ST Elevation (STEMI) Myocardial InfarctionNCT07366684
Clinical Characteristics, Frailty, and Prognostic Predictors in Patients Aged 75 and Older With Acute Coronary Syndrome
An observational study of ST Elevation (STEMI) Myocardial Infarction and Non ST Elevation Myocardial Infarction (NSTEMI), run by Clinical Center Niš at 1 site in Serbia.
Trial summary
This study will evaluate clinical characteristics, frailty, and predictors of prognosis in patients aged 75 years and older who are hospitalized with acute coronary syndrome (ACS). The research includes both a retrospective and a prospective cohort. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction, Non ST Elevation Myocardial Infarction (NSTEMI), Unstable Angina Pectoris
- What is being tested?
- Percutaneous Coronary Intervention (PCI) and Conservative Medical Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 550 participants
- Where
- 1 siteSerbia
- Study dates
- 13 May 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized patients aged 75 years and older with acute coronary syndrome (STEMI, NSTEMI, unstable angina) treated at the University Clinical Center Niš. Approximately 350 retrospective and 200 prospective patients are expected to be included.
Who may be able to join
- Age ≥ 75 years
- Diagnosis of acute coronary syndrome (STEMI, NSTEMI, or unstable angina)
- Hospitalization in a tertiary care center (University Clinical Center Niš)
- For prospective cohort: signed informed consent
Who cannot join
- Refusal to provide informed consent (prospective cohort)
- Missing or incomplete medical documentation (retrospective cohort)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia1 site, 1 recruiting
- Recruiting
Clinical Center Niš
Niš, 18000
Svetlana Apostolović, MD, PhD, +381631094144, drapostolovic@gmail.com
About this study
Official title: Investigation of Clinical Characteristics, Frailty, and Predictors of In-Hospital and Six-Month Prognosis in Hospitalized Patients Aged 75 Years and Older With Acute Coronary Syndrome
This study will evaluate clinical characteristics, frailty, and predictors of prognosis in patients aged 75 years and older who are hospitalized with acute coronary syndrome (ACS). The research includes both a retrospective and a prospective cohort. The aim is to determine whether frailty scores, combined with clinical and laboratory parameters available at admission, can improve risk prediction for complications and mortality compared with standard risk scores (TIMI, GRACE, Syntax). The study will also compare outcomes between patients treated with percutaneous coronary intervention (PCI) and those treated conservatively with medications. Patients will be followed during hospitalization and for six months after discharge. The results are expected to contribute to more personalized treatment strategies for elderly patients with ACS.
Read the detailed description
This observational study will evaluate clinical characteristics,frailty, and prognostic predictors in patients aged 75 years and older hospitalized with acute coronary syndrome (ACS). The study is designed with two complementary components:
Retrospective cohort (≈350 patients):
Data will be collected from electronic medical records of patients previously hospitalized with ACS. Variables include demographics, comorbidities, laboratory findings (hematology, biochemistry, cardiac biomarkers), ECG changes, echocardiographic parameters, and coronary angiography results. Standard risk scores (TIMI, GRACE, Syntax) will be compared with observed outcomes. Data integrity will be ensured through double-entry verification, and missing values will be addressed using multiple imputation.
Prospective cohort (≈800 patients):
Patients will be consecutively enrolled at admission with ACS. Data collection will include the same parameters as in the retrospective cohort, with additional dynamic laboratory monitoring and frailty assesment. Frailty will be assessed within 48 hours of admission using the Rockwood Frailty Scale, performed by trained investigators. Echocardiography and coronary angiography will be conducted according to institutional protocols. Patients will be followed during hospitalization and 6 months after discharge, using structured case report forms and telephone interviews. Outcomes will include major adverse cardiovascular events (MACE), all-cause mortality, rehospitalizations, PCI-related complications (vascular, gastrointestinal bleeding, neurological), and treatment adherence.
Data management and statistical analysis:
All data will be entered into a secure, password-protected database with regular quality control checks. Statistical analyses will be performed using SPSS v.27 and R. Methods include descriptive statistics, univariate and multivariate logistic regression, ROC curve analysis, and comparison of AUC values. Predictors identified in the retrospective cohort will be validated in the prospective cohort.
The study team consists of cardiologists, statisticians, and trained research staff responsible for patient enrollment, frailty assessment, and data monitoring. Complications and adverse events will be defined according to standardized cardiology guidelines and adjudicated by an independent committee.
The study is conducted in accordance with the Declaration of Helsinki. Retrospective data collection does not require informed consent, while prospective participants will provide written informed consent. The expected contribution is improved risk stratification and more personalized therapeutic approaches for elderly patients with ACS.
- Conditions
- ST Elevation (STEMI) Myocardial Infarction, Non ST Elevation Myocardial Infarction (NSTEMI), Unstable Angina Pectoris
- Being tested
- Percutaneous Coronary Intervention (PCI), Conservative Medical Therapy
- Keywords
- Acute Coronary Syndrome (ACS), Elderly, Frailty, Percutaneous Coronary Intervention (PCI), Conservative Treatment, Major adverse cardiovascular events (MACE), Prognostic Predictors / Risk Stratification
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Angina, Unstable, Acute Coronary Syndrome, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention (PCI)Procedure or surgery
Patients receiving PCI as part of routine clinical care
Conservative Medical TherapyOther
Patients treated conservatively with guideline-directed medical therapy as part of routine care
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Patients ≥75 Years With Acute Coronary Syndrome | Patients aged 75 years and older admitted with acute coronary syndrome (STEMI, NSTEMI, or unstable angina). Data will be collected retrospectively and prospectively, including clinical, laboratory, echocardiographic, angiographic, and frailty parameters. Outcomes will be assessed during hospitalization and at 6 months after discharge. Receives: Procedure: Percutaneous Coronary Intervention (PCI); Other: Conservative Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of treatment strategy (PCI vs conservative therapy) on on all-cause mortality and major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke) in elderly patients with acute coronary syndrome (ACS)
To compare outcomes of patients aged ≥75 years with ACS (STEMI, NSTEMI, unstable angina) treated with percutaneous coronary intervention (PCI) versus conservative medical therapy. The primary outcome includes all-cause mortality and major adverse cardiovascular events (MACE). Unit of Measure: % of patients experiencing event.
Measured: Peri-procedurally (within 48 hours of PCI or index admission for conservative therapy), at discharge (assessed up to 14 days after admission (Day 1)), and at 6 months after discharge (± 14 days).
Secondary outcomes (28)
Impact of treatment strategy (PCI vs conservative therapy) on hemorrhagic complications
Incidence of major bleeding, defined as clinically overt bleeding resulting in hemodynamic compromise, intracranial hemorrhage, bleeding requiring transfusion, or bleeding requiring surgical or endovascular hemostatic intervention; includes gastrointestinal and access-site bleeding. Unit of Measure: Incidence (%)
Measured: Peri-procedurally (within 48 hours of PCI or index admission) and at discharge (assessed up to 14 days after admission (Day 1)).
Number of Participants with ≥1 All-cause Rehospitalization
Proportion of patients with ≥1 rehospitalization for any cause and total number of rehospitalizations per patient during follow-up; comparison between PCI and conservative therapy. Unit of Measure: % of patients with ≥1 rehospitalization; count per patient.
Measured: 6 months after discharge (± 14 days).
Demographic predictors of conservative management
Patient age and sex as predictors of the decision to pursue conservative medical therapy instead of percutaneous coronary intervention (PCI). Independent predictors will be identified using multivariable logistic regression and reported as odds ratios with 95% confidence intervals.
Measure: Age (years); Sex (male/female).
Measured: Baseline (Day 1).
Admission hemoglobin as predictor of conservative management
Hemoglobin concentration measured at admission and recorded in the dataset. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: g/L.
Measured: Baseline.
Admission eGFR (CKD-EPI) as predictor of conservative management
Estimated glomerular filtration rate (CKD-EPI) measured at admission and recorded in the dataset. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: mL/min/1.73 m².
Measured: Baseline.
Admission hs-Troponin I as predictor of conservative management
High-sensitivity troponin I measured at admission; assay name and 99th percentile documented. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: ng/L.
Measured: Baseline.
Admission CRP as predictor of conservative management
C-reactive protein measured at admission and recorded in the dataset. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: mg/L.
Measured: Baseline.
Admission BNP/NT-proBNP as predictor of conservative management
BNP or NT-proBNP measured at admission and recorded in the dataset. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: pg/mL.
Measured: Baseline.
Admission HbA1c as predictor of conservative management
Glycated hemoglobin (HbA1c) measured at admission and recorded in the dataset. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: %.
Measured: Baseline.
Composite admission laboratory abnormality score as predictor of conservative management
Composite score derived from admission laboratory parameters not otherwise specified as individual outcomes. Included analytes: WBC with differential, RBC, HCT, MCV, MCH, MCHC, PLT, Glucose, urea, creatinine, total proteins, albumin, Total cholesterol, HDL, LDL, triglycerides, Na, K, Cl, Ca, AST, ALT, GGT, LDH, CK-MB, TSH.
Each analyte will be coded as 1 if outside the central hospital laboratory reference range and 0 if within range (assay name, manufacturer, units, and reference intervals documented). The composite score equals the total number of abnormal parameters per patient and will be entered as a single predictor variable in multivariable logistic regression to evaluate its association with the decision for conservative therapy versus PCI. Missing data will be handled by multiple imputation; sensitivity analyses will assess robustness. Unit of Measure: Count (number of abnormal parameters per patient).
Measured: Baseline.
ECG ischemic changes at admission as predictor of conservative management
Binary composite coded as 1 if any of the following are present on the admission ECG: ST elevation, ST depression, T-wave inversion, or pathologic q/Q/qS complexes; coded as 0 if none are present. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Unit of measure: Presence/absence (yes/no).
Measured: Baseline
ECG rhythm and arrhythmias at admission as predictor of conservative management
Binary composite coded as 1 if any of the following are present on the admission ECG: atrial fibrillation (any), atrial flutter, supraventricular tachycardia, premature atrial complexes, premature ventricular complexes, non-sustained VT, sustained VT, ventricular fibrillation, or accelerated idioventricular rhythm; coded as 0 if none are present. Evaluated as a predictor of the decision for conservative therapy versus PCI. Unit of measure: Presence/absence (yes/no).
Measured: Baseline.
ECG conduction abnormalities at admission as predictor of conservative management
Binary composite coded as 1 if any of the following are present on the admission ECG: sinoatrial block, sick sinus syndrome, atrioventricular block (any degree), right bundle branch block, left bundle branch block, left anterior hemiblock, or left posterior hemiblock; coded as 0 if none are present. Evaluated as a predictor of the decision for conservative therapy versus PCI.
Measured: Baseline
Angiographic high-risk anatomy composite as predictor of conservative management
Binary composite coded as 1 if any of the following are present on coronary angiography prior to the treatment decision: left main coronary lesion (≥50% luminal stenosis), multivessel coronary disease (≥2 epicardial vessels with significant stenosis), bifurcation lesion, or ≥70% stenosis in any vessel; coded as 0 if none are present. Evaluated as a predictor of the decision to pursue conservative medical therapy versus PCI in multivariable logistic regression. Unit of measure: Presence/absence (yes/no).
Measured: Peri-procedurally (immediately after angiography); values used are those available at or prior to the documented treatment decision (decision documented within 48 hours of admission).
Left Ventricular Ejection Fraction as predictor of conservative management
Categorical coded as 1 if LVEF ≤40%, coded as 2 if 41-49%, coded as 3 if ≥50%, based on Teichholz, Simpson biplane, or visual estimation if biplane unavailable. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.
Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
E/e' ratio as predictor of conservative management
Binary composite coded as 1 if average E/e' ≥16, coded as 0 if <16. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.
Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
Pericardial effusion as predictor of conservative management
Binary coded as 1 if effusion present, coded as 0 if absent. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.
Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
Left Atrial Volume Index as predictor of conservative management
Categorical coded as 1 if LAVI ≥34 mL/m², coded as 0 if <34 mL/m². Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.
Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
Wall Motion Score Index as predictor of conservative management
Categorical coded as 1 if WMSI >1.0, coded as 0 if ≤1.0. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.
Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
Valvular regurgitation as predictor of conservative management
Binary composite coded as 1 if any of the following are present: aortic regurgitation, mitral regurgitation, pulmonary regurgitation, or tricuspid regurgitation; coded as 0 if none are present. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.
Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
Comorbidity predictors of conservative management
Presence of predefined comorbid conditions recorded at admission and used as predictors of the decision for conservative therapy versus PCI. Each comorbidity will be recorded using standard clinical definitions and ICD codes where available. Comorbidities will be coded as binary variables (yes/no); chronic kidney disease will be classified by KDIGO stage (CKD stage 1-5). Candidate comorbid predictors will be evaluated in univariate analyses and included in multivariable logistic regression based on clinical relevance and univariate p<0.10. Missing data will be handled by multiple imputation; sensitivity analyses will be performed.
Measured: At admission (baseline, pre-intervention/decision).
Frailty predictors of conservative management
Frailty assessed at admission using the Rockwood Clinical Frailty Scale (CFS) and the Hopkins frailty instrument; assessor initials and assessment timing recorded. Scores modeled primarily as continuous and secondarily as prespecified categorical variables; inclusion in multivariable logistic regression guided by univariate screening and clinical relevance; missing data handled by multiple imputation. Measure: Rockwood CFS coded as: 0 (score 1-3); 1 (score 4-6); 2 (score 7-9). Hopkins frailty coded as: 0 (score 0); 1 (score 1-2); 2 (score 3-5). Raw Rockwood CFS (1-9) and raw Hopkins score (numeric) will be recorded.
Measured: At admission (baseline, pre-intervention/decision).
Number of Participants with Major Adverse Cardiovascular Events (MACE)
Composite endpoint defined as cardiovascular death, myocardial infarction, or stroke. Participants will be coded as positive if any of these events occur, and negative if none occur. Unit of measure: Presence/absence (yes/no).
Measured: Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).
Number of Participants with Cardiovascular Rehospitalization
Presence/absence of rehospitalization due to cardiovascular causes (including acute coronary syndrome, heart failure, arrhythmia, stroke, or repeat revascularization). Unit of measure: Presence/absence (yes/no).
Measured: Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).
Number of Participants with All-cause Mortality
Presence/absence of death from any cause. Unit of measure: Presence/absence (yes/no).
Measured: Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).
Correlation between clinical predictors and clinical outcomes (in-hospital MACE and 6-month all-cause mortality)
The outcomes are in-hospital major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke) and all-cause mortality at 6 months. Each outcome will be reported separately. Candidate predictors include demographic characteristics, prespecified comorbidities, admission laboratory values (including renal function and eGFR), echocardiographic measures (e.g., LVEF, LV volumes, LAVI, TAPSE), ECG parameters (e.g., ST elevation/depression, T-wave inversion, rhythm abnormalities, conduction blocks), and angiographic findings (culprit vessel, multivessel disease, left main disease, percent stenosis). Independent predictors will be identified using multivariable logistic regression for in-hospital MACE and Cox proportional hazards models for 6-month mortality. Full variable definitions, units, assay names, and reference ranges are provided in the SAP.
Measured: Predictors measured at admission (baseline). In-hospital MACE assessed during hospitalization (up to 15 days after admission). Six-month all-cause mortality assessed 6 months after discharge (±14 days).
Correlation between frailty scores and cognitive categories and clinical outcomes (in-hospital MACE and 6-month all-cause mortality).
Frailty and cognition will be assessed at admission using the Rockwood Clinical Frailty Scale (CFS, range 1-9; higher = greater frailty), the Hopkins frailty instrument (range 0-5; higher = greater frailty), and the Mini-Mental State Examination (MMSE, range 0-30; higher = better cognition). Clinical outcomes are in-hospital MACE (composite of cardiovascular death, myocardial infarction, and stroke) and all-cause mortality at 6 months. Results will be reported by the prespecified score categories (CFS 1-3 / 4-6 / 7-9; Hopkins 0 / 1-2 / 3-5; MMSE <24 vs ≥24) and expressed as the percentage of patients with each outcome within categories. Statistical analysis will include correlation coefficients (Spearman or Pearson as appropriate) and multivariable models comparing categories (logistic regression for in-hospital MACE; Cox proportional hazards for 6-month mortality); reference groups, covariates and all cutoffs are specified in the SAP.
Measured: Scores measured at admission, outcomes assessed at discharge (up to 14 days after admission), and outcomes reassessed 6 months after discharge (± 14 days).
Secondary complications and adverse events
Incidence of periprocedural complications, gastrointestinal bleeding, neurological complications, and psychiatric disorders (e.g., psycho-organic syndrome).
Measured: Peri-procedurally, at discharge (assessed up to 14 days after admission (Day 1)), and at 6 months after discharge (± 14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start13 May 2026
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ST Elevation (STEMI) Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Center Niš
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nis
- Responsible party
- Principal investigator, Svetlana Apostolović, Clinical Center Niš
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366684
- Sponsor's protocol ID
- ACS75-NIS-2025
- Status last verified
- May 2026
- First submitted
- 1 Dec 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including demographics, clinical, laboratory, echocardiographic, angiographic, frailty scores, and outcomes, will be made available. A data dictionary will also be provided. Data will be shared with qualified researchers upon reasonable request, after publication of the main results, for up to 5 years. Access will require approval by the principal investigator and a signed data use agreement.
Publications
Narendren A, Whitehead N, Burrell LM, Yudi MB, Yeoh J, Jones N, Weinberg L, Miles LF, Lim HS, Clark DJ, Al-Fiadh A, Farouque O, Koshy AN. Management of Acute Coronary Syndromes in Older People: Comprehensive Review and Multidisciplinary Practice-Based Recommendations. J Clin Med. 2024 Jul 28;13(15):4416. doi: 10.3390/jcm13154416.
PubMed 39124683Morici N, De Servi S, De Luca L, Crimi G, Montalto C, De Rosa R, De Luca G, Rubboli A, Valgimigli M, Savonitto S. Management of acute coronary syndromes in older adults. Eur Heart J. 2022 Apr 19;43(16):1542-1553. doi: 10.1093/eurheartj/ehab391.
PubMed 34347065H Ratcovich, P Palm, J Faerch, L Bang, T Engstroem, H H Tilsted, L Holmvang, Prevalence and prognosis of frailty in patients >70 years old with acute coronary syndrome referred to invasive angiography. Eur Heart J Acute Cardiovasc Care. 2023;12(Suppl 1):zuad036.045. doi:10.1093/ehjacc/zuad036.045
Szummer K, Montez-Rath ME, Alfredsson J, Erlinge D, Lindahl B, Hofmann R, Ravn-Fischer A, Svensson P, Jernberg T. Comparison Between Ticagrelor and Clopidogrel in Elderly Patients With an Acute Coronary Syndrome: Insights From the SWEDEHEART Registry. Circulation. 2020 Nov 3;142(18):1700-1708. doi: 10.1161/CIRCULATIONAHA.120.050645. Epub 2020 Sep 1.
PubMed 32867508Aranzulla TC, Radano I, Civera S, Musumeci G. Acute coronary syndrome in elderly and frail patients. European Society of Cardiology - Council for Cardiology Practice, CardioPractice. Published August 6, 2024. Available at: https://www.escardio.org/Councils/Council-for-Cardiology-Practice-%28CCP%29/Cardiopractice/acute-coronary-syndrome-in-elderly-and-frail-patients
Damluji AA, Forman DE, Wang TY, Chikwe J, Kunadian V, Rich MW, Young BA, Page RL 2nd, DeVon HA, Alexander KP; American Heart Association Cardiovascular Disease in Older Populations Committee of the Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; and Council on Lifestyle and Cardiometabolic Health. Management of Acute Coronary Syndrome in the Older Adult Population: A Scientific Statement From the American Heart Association. Circulation. 2023 Jan 17;147(3):e32-e62. doi: 10.1161/CIR.0000000000001112. Epub 2022 Dec 12.
PubMed 36503287Rout A, Moumneh MB, Kalra K, Singh S, Garg A, Kunadian V, Biscaglia S, Alkhouli MA, Rymer JA, Batchelor WB, Nanna MG, Damluji AA. Invasive Versus Conservative Strategy in Older Adults >/=75 Years of Age With Non-ST-segment-Elevation Acute Coronary Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2024 Nov 5;13(21):e036151. doi: 10.1161/JAHA.124.036151. Epub 2024 Nov 4.
PubMed 39494560
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Clinical Characteristics, Frailty, and Predictors of In-Hospital and Six-Month Prognosis in Hospitalized Patients Aged 75 Years and Older With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07366684
- Acronym / sponsor ID
- ACS75-NIS-2025
- Conditions
- ST Elevation (STEMI) Myocardial Infarction, Non ST Elevation Myocardial Infarction (NSTEMI), Unstable Angina Pectoris
- Keywords
- Acute Coronary Syndrome (ACS), Elderly, Frailty, Percutaneous Coronary Intervention (PCI), Conservative Treatment, Major adverse cardiovascular events (MACE), Prognostic Predictors / Risk Stratification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Clinical Center NišUniversity, hospital or other
- Collaborators
- University of Nis
- Study start
- 13 May 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate clinical characteristics, frailty, and predictors of prognosis in patients aged 75 years and older who are hospitalized with acute coronary syndrome (ACS). The research includes both a retrospective and a prospective cohort. The aim is to determine whether frailty scores, combined with clinical and laboratory parameters available at admission, can improve risk prediction for complications and mortality compared with standard risk scores (TIMI, GRACE, Syntax). The study will also compare outcomes between patients treated with percutaneous coronary intervention (PCI) and those treated conservatively with medications. Patients will be followed during hospitalization and for six months after discharge. The results are expected to contribute to more personalized treatment strategies for elderly patients with ACS.
Detailed description
This observational study will evaluate clinical characteristics,frailty, and prognostic predictors in patients aged 75 years and older hospitalized with acute coronary syndrome (ACS). The study is designed with two complementary components:
Retrospective cohort (≈350 patients):
Data will be collected from electronic medical records of patients previously hospitalized with ACS. Variables include demographics, comorbidities, laboratory findings (hematology, biochemistry, cardiac biomarkers), ECG changes, echocardiographic parameters, and coronary angiography results. Standard risk scores (TIMI, GRACE, Syntax) will be compared with observed outcomes. Data integrity will be ensured through double-entry verification, and missing values will be addressed using multiple imputation.
Prospective cohort (≈800 patients):
Patients will be consecutively enrolled at admission with ACS. Data collection will include the same parameters as in the retrospective cohort, with additional dynamic laboratory monitoring and frailty assesment. Frailty will be assessed within 48 hours of admission using the Rockwood Frailty Scale, performed by trained investigators. Echocardiography and coronary angiography will be conducted according to institutional protocols. Patients will be followed during hospitalization and 6 months after discharge, using structured case report forms and telephone interviews. Outcomes will include major adverse cardiovascular events (MACE), all-cause mortality, rehospitalizations, PCI-related complications (vascular, gastrointestinal bleeding, neurological), and treatment adherence.
Data management and statistical analysis:
All data will be entered into a secure, password-protected database with regular quality control checks. Statistical analyses will be performed using SPSS v.27 and R. Methods include descriptive statistics, univariate and multivariate logistic regression, ROC curve analysis, and comparison of AUC values. Predictors identified in the retrospective cohort will be validated in the prospective cohort.
The study team consists of cardiologists, statisticians, and trained research staff responsible for patient enrollment, frailty assessment, and data monitoring. Complications and adverse events will be defined according to standardized cardiology guidelines and adjudicated by an independent committee.
The study is conducted in accordance with the Declaration of Helsinki. Retrospective data collection does not require informed consent, while prospective participants will provide written informed consent. The expected contribution is improved risk stratification and more personalized therapeutic approaches for elderly patients with ACS.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Patients ≥75 Years With Acute Coronary Syndrome | – | Procedure: Percutaneous Coronary Intervention (PCI), Other: Conservative Medical TherapyPatients aged 75 years and older admitted with acute coronary syndrome (STEMI, NSTEMI, or unstable angina). Data will be collected retrospectively and prospectively, including clinical, laboratory, echocardiographic, angiographic, and frailty parameters. Outcomes will be assessed during hospitalization and at 6 months after discharge. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized patients aged 75 years and older with acute coronary syndrome (STEMI, NSTEMI, unstable angina) treated at the University Clinical Center Niš. Approximately 350 retrospective and 200 prospective patients are expected to be included.
Key inclusion criteria (4 listed)
- Age ≥ 75 years
- Diagnosis of acute coronary syndrome (STEMI, NSTEMI, or unstable angina)
- Hospitalization in a tertiary care center (University Clinical Center Niš)
- For prospective cohort: signed informed consent
Key exclusion criteria (2 listed)
- Refusal to provide informed consent (prospective cohort)
- Missing or incomplete medical documentation (retrospective cohort)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary Intervention (PCI)Patients receiving PCI as part of routine clinical care | Procedure or surgery | Hospitalized Patients ≥75 Years With Acute Coronary Syndrome |
| Conservative Medical TherapyPatients treated conservatively with guideline-directed medical therapy as part of routine care | Other | Hospitalized Patients ≥75 Years With Acute Coronary Syndrome |
Primary outcome
Impact of treatment strategy (PCI vs conservative therapy) on on all-cause mortality and major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke) in elderly patients with acute coronary syndrome (ACS)
Time frame: Peri-procedurally (within 48 hours of PCI or index admission for conservative therapy), at discharge (assessed up to 14 days after admission (Day 1)), and at 6 months after discharge (± 14 days).
To compare outcomes of patients aged ≥75 years with ACS (STEMI, NSTEMI, unstable angina) treated with percutaneous coronary intervention (PCI) versus conservative medical therapy. The primary outcome includes all-cause mortality and major adverse cardiovascular events (MACE). Unit of Measure: % of patients experiencing event.
28 secondary outcomes
Impact of treatment strategy (PCI vs conservative therapy) on hemorrhagic complications
Time frame: Peri-procedurally (within 48 hours of PCI or index admission) and at discharge (assessed up to 14 days after admission (Day 1)).
Number of Participants with ≥1 All-cause Rehospitalization
Time frame: 6 months after discharge (± 14 days).
Demographic predictors of conservative management
Time frame: Baseline (Day 1).
Admission hemoglobin as predictor of conservative management
Time frame: Baseline.
Admission eGFR (CKD-EPI) as predictor of conservative management
Time frame: Baseline.
Admission hs-Troponin I as predictor of conservative management
Time frame: Baseline.
Admission CRP as predictor of conservative management
Time frame: Baseline.
Admission BNP/NT-proBNP as predictor of conservative management
Time frame: Baseline.
Admission HbA1c as predictor of conservative management
Time frame: Baseline.
Composite admission laboratory abnormality score as predictor of conservative management
Time frame: Baseline.
ECG ischemic changes at admission as predictor of conservative management
Time frame: Baseline
ECG rhythm and arrhythmias at admission as predictor of conservative management
Time frame: Baseline.
ECG conduction abnormalities at admission as predictor of conservative management
Time frame: Baseline
Angiographic high-risk anatomy composite as predictor of conservative management
Time frame: Peri-procedurally (immediately after angiography); values used are those available at or prior to the documented treatment decision (decision documented within 48 hours of admission).
Left Ventricular Ejection Fraction as predictor of conservative management
Time frame: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
E/e' ratio as predictor of conservative management
Time frame: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
Pericardial effusion as predictor of conservative management
Time frame: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
Left Atrial Volume Index as predictor of conservative management
Time frame: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
Wall Motion Score Index as predictor of conservative management
Time frame: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
Valvular regurgitation as predictor of conservative management
Time frame: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.
Comorbidity predictors of conservative management
Time frame: At admission (baseline, pre-intervention/decision).
Frailty predictors of conservative management
Time frame: At admission (baseline, pre-intervention/decision).
Number of Participants with Major Adverse Cardiovascular Events (MACE)
Time frame: Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).
Number of Participants with Cardiovascular Rehospitalization
Time frame: Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).
Number of Participants with All-cause Mortality
Time frame: Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).
Correlation between clinical predictors and clinical outcomes (in-hospital MACE and 6-month all-cause mortality)
Time frame: Predictors measured at admission (baseline). In-hospital MACE assessed during hospitalization (up to 15 days after admission). Six-month all-cause mortality assessed 6 months after discharge (±14 days).
Correlation between frailty scores and cognitive categories and clinical outcomes (in-hospital MACE and 6-month all-cause mortality).
Time frame: Scores measured at admission, outcomes assessed at discharge (up to 14 days after admission), and outcomes reassessed 6 months after discharge (± 14 days).
Secondary complications and adverse events
Time frame: Peri-procedurally, at discharge (assessed up to 14 days after admission (Day 1)), and at 6 months after discharge (± 14 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 39124683Narendren A, Whitehead N, Burrell LM, Yudi MB, Yeoh J, Jones N, Weinberg L, Miles LF, Lim HS, Clark DJ, Al-Fiadh A, Farouque O, Koshy AN. Management of Acute Coronary Syndromes in Older People: Comprehensive Review and Multidisciplinary Practice-Based Recommendations. J Clin Med. 2024 Jul 28;13(15):4416. doi: 10.3390/jcm13154416.
- Background: PubMed 34347065Morici N, De Servi S, De Luca L, Crimi G, Montalto C, De Rosa R, De Luca G, Rubboli A, Valgimigli M, Savonitto S. Management of acute coronary syndromes in older adults. Eur Heart J. 2022 Apr 19;43(16):1542-1553. doi: 10.1093/eurheartj/ehab391.
- BackgroundH Ratcovich, P Palm, J Faerch, L Bang, T Engstroem, H H Tilsted, L Holmvang, Prevalence and prognosis of frailty in patients >70 years old with acute coronary syndrome referred to invasive angiography. Eur Heart J Acute Cardiovasc Care. 2023;12(Suppl 1):zuad036.045. doi:10.1093/ehjacc/zuad036.045
- Background: PubMed 32867508Szummer K, Montez-Rath ME, Alfredsson J, Erlinge D, Lindahl B, Hofmann R, Ravn-Fischer A, Svensson P, Jernberg T. Comparison Between Ticagrelor and Clopidogrel in Elderly Patients With an Acute Coronary Syndrome: Insights From the SWEDEHEART Registry. Circulation. 2020 Nov 3;142(18):1700-1708. doi: 10.1161/CIRCULATIONAHA.120.050645. Epub 2020 Sep 1.
- BackgroundAranzulla TC, Radano I, Civera S, Musumeci G. Acute coronary syndrome in elderly and frail patients. European Society of Cardiology - Council for Cardiology Practice, CardioPractice. Published August 6, 2024. Available at: https://www.escardio.org/Councils/Council-for-Cardiology-Practice-%28CCP%29/Cardiopractice/acute-coronary-syndrome-in-elderly-and-frail-patients
- Background: PubMed 36503287Damluji AA, Forman DE, Wang TY, Chikwe J, Kunadian V, Rich MW, Young BA, Page RL 2nd, DeVon HA, Alexander KP; American Heart Association Cardiovascular Disease in Older Populations Committee of the Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; and Council on Lifestyle and Cardiometabolic Health. Management of Acute Coronary Syndrome in the Older Adult Population: A Scientific Statement From the American Heart Association. Circulation. 2023 Jan 17;147(3):e32-e62. doi: 10.1161/CIR.0000000000001112. Epub 2022 Dec 12.
- Background: PubMed 39494560Rout A, Moumneh MB, Kalra K, Singh S, Garg A, Kunadian V, Biscaglia S, Alkhouli MA, Rymer JA, Batchelor WB, Nanna MG, Damluji AA. Invasive Versus Conservative Strategy in Older Adults >/=75 Years of Age With Non-ST-segment-Elevation Acute Coronary Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2024 Nov 5;13(21):e036151. doi: 10.1161/JAHA.124.036151. Epub 2024 Nov 4.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including demographics, clinical, laboratory, echocardiographic, angiographic, frailty scores, and outcomes, will be made available. A data dictionary will also be provided. Data will be shared with qualified researchers upon reasonable request, after publication of the main results, for up to 5 years. Access will require approval by the principal investigator and a signed data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation (STEMI) Myocardial Infarction and Non ST Elevation Myocardial Infarction (NSTEMI), run by Clinical Center Niš at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Svetlana Apostolović (+381631094144, drapostolovic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of treatment strategy (PCI vs conservative therapy) on on all-cause mortality and major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke) in elderly patients with acute coronary syndrome (ACS) (time frame: Peri-procedurally (within 48 hours of PCI or index admission for conservative therapy), at discharge (assessed up to 14 days after admission (Day 1)), and at 6 months after discharge (± 14 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07366684, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.