ACS (Acute Coronary Syndrome)TIRANA (ACS)NCT07026708
TIRANA-ACS: A Prospective Registry Study for the Targeted Investigation of Residual Inflammation After Non-ST/ ST Elevation Acute Coronary Syndrome
An observational study of ACS (Acute Coronary Syndrome) and Myocardial Infarction (MI), run by University Hospital Centre Mother Teresa at 1 site in Albania.
Trial summary
This prospective observational study aims to evaluate the prognostic significance of the neutrophil-to-lymphocyte ratio (NLR) as a predictor of mortality in patients following an episode of Acute Coronary Syndrome (ACS). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ACS (Acute Coronary Syndrome), Myocardial Infarction (MI), Myocardial Inflammation
- How many people
- 1,600 participants
- Where
- 1 siteAlbania
- Study dates
- 1 Nov 2024to 1 Jun 2027
- How long will I take part?
- 2 Years
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General patient information, diagnosis, comorbidities, CRP levels, neutrophil and lymphocyte counts, thrombocyte count, HDL cholesterol, LDL cholesterol, and complications (electrical and mechanical) will be collected from the medical records in the cardiology department of our main tertiary hospital "Mother Teresa Hospital". Angiographic data and treatment information will be gathered from standard coronary angiography reports used at our cardiac catheterization laboratories. The follow-up form used for telephone interviews with patients is based on standardized instruments, including the WHO Rose Angina Questionnaire, Seattle Angina Questionnaire, EQ-5D-5L, MacNew Heart Disease Health-Related Quality of Life Questionnaire, McGill Pain Questionnaire, and the MRC Dyspnoea Scale. Patient status will be evaluated at 24 hours, 48 hours, and 6 months after the onset of symptoms. The symptom onset time will be obtained from medical records documented upon patient referral.
Who may be able to join
- All patients (undergoing PCI, aged 18-85 years) presenting to the cardiology department or/and the cardiology intensive care unit with a diagnosis of ACS
Who cannot join
- Patients presenting to the cardiology department or/and the cardiology intensive care unit with diagnoses other than ACS and/or UA. Patients who died before undergoing PCI and those who did not provide a contact number.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Albania1 site, 1 recruiting
- Recruiting
Faculty of Medicine Tirana
Tirana, 1005
Alban Dibra, Prof . Dr, PhD, +355682085837, a_dibra@yahoo.com
Martiola Kola, +355693410998, martiola.kola@gmail.com
About this study
Official title: Target Investigation of Residual Inflammation After Non-ST/ ST Elevation Acute Coronary Syndrome - TIRANA (ACS) Prospective REGISTRY
This prospective observational study aims to evaluate the prognostic significance of the neutrophil-to-lymphocyte ratio (NLR) as a predictor of mortality in patients following an episode of Acute Coronary Syndrome (ACS). Despite advancements in interventional cardiology and medical therapy, mortality remains significant in post-ACS patients, and early risk stratification is essential for optimizing outcomes.
Recent studies have suggested that systemic inflammatory markers, such as NLR, are associated with adverse cardiovascular events. It is an easily obtainable and cost-effective laboratory parameter derived from a routine complete blood count. However, its value as an independent predictor of mortality post-ACS has not yet been fully established in our population.
Read more
The study will include patients aged, admitted with a confirmed diagnosis of ACS (STEMI or Non-STEMI) and treated with percutaneous coronary intervention (PCI). NLR values will be measured from the first blood draw upon hospital admission, 24 and 48 hours post PCI. Patients will be followed up for up to 6 months after discharge through telephone interviews .
First, primary outcomes of the study will be the association between NLR values and mortality (all cause mortality and cardiovascular mortality), MACE (MACE was defined as the composite of all-cause mortality, cardiac death, unplanned revascularization, non-fatal myocardial infarction that was attributable and not related to stent failure or unplanned revascularization not related to stent failure) within 6 months post-ACS.
Secondary outcomes will include:
- Differences in mean NLR between STEMI and NSTEMI patients.
- Association between elevated NLR and the presence of multivessel coronary artery disease on angiography.
- Correlation of NLR with other biomarkers, including the platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), high-density lipoprotein (HDL) cholesterol, and maximum troponin levels (as an indicator of myocardial infarction size)
This study aims to contribute to the identification of easily accessible and cost-efficient biomarkers that can aid clinicians in early risk stratification of ACS survivors. A strong correlation between high NLR values and increased post-discharge mortality would suggest that inflammation plays a key role in patient prognosis and could potentially influence post-ACS management strategies.
- Conditions
- ACS (Acute Coronary Syndrome), Myocardial Infarction (MI), Myocardial Inflammation, Inflammation Biomarkers, NSTEMI - Non-ST Segment Elevation MI, STEMI
- Keywords
- Residual inflammation, Myocardial infarction, Percutaneous Coronary Intervention, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Myocarditis, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Coronary Syndrome Patients | Data Collection: General patient information, diagnosis, comorbidities, CRP levels, neutrophil and lymphocyte counts, thrombocyte count, HDL cholesterol, LDL cholesterol, and complications (electrical and mechanical) will be collected from the medical records in the cardiology department of our main tertiary hospital "Mother Teresa Hospital". Angiographic data and treatment information will be gathered from standard coronary angiography reports used at our cardiac catheterization laboratories. The follow-up form used for telephone interviews with patients is based on standardized instruments, including the WHO Rose Angina Questionnaire, Seattle Angina Questionnaire, EQ-5D-5L, MacNew Heart Disease Health-Related Quality of Life Questionnaire, McGill Pain Questionnaire, and the MRC Dyspnoea Scale. Patient status will be evaluated at 24 hours, 48 hours, and 6 months after the onset of symptoms. The symptom onset time will be obtained from medical records documented upon patient referral. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil-to-Lymphocyte Ratio (NLR)
Association Between Neutrophil-to-Lymphocyte Ratio (NLR) and Mortality (all cause mortality and cardiovascular mortality), MACE (MACE was defined as the composite of all-cause mortality, cardiac death, unplanned revascularization, non-fatal myocardial infarction that was attributable and not related to stent failure or unplanned revascularization not related to stent failure) in Post-Acute Coronary Syndrome (ACS) Patients .
This outcome assesses the predictive value of NLR levels for mortality within 6 months following an ACS event.
Measured: 6 months post-ACS with a potential prolonged period of roughly 12 months
Mortality (all cause mortality and cardiovascular mortality)
Mortality (all cause mortality and cardiovascular mortality) in Post-Acute Coronary Syndrome (ACS) Patients .
Measured: 6 months post-ACS with a potential prolonged period of roughly 12 months
MACE (Major Acute Coronary Events)
MACE was defined as the composite of all-cause mortality, cardiac death, unplanned revascularization, non-fatal myocardial infarction that was attributable and not related to stent failure or unplanned revascularization not related to stent failure in Post-Acute Coronary Syndrome (ACS) Patients .
Measured: 6 months post-ACS with a potential prolonged period of roughly 12 months
Secondary outcomes (4)
Difference in Mean NLR Between STEMI and NSTEMI Patients
This outcome evaluates the variation in mean NLR values among patients diagnosed with ST-Elevation Myocardial Infarction (STEMI) versus Non-ST-Elevation Myocardial Infarction (NSTEMI).
Time Frame: At hospital admission
Measured: At hospital admission
Association Between High NLR and Presence of Multivessel Coronary Artery Disease
This outcome explores whether elevated NLR values are associated with the presence of multivessel disease identified during coronary angiography.
Measured: During initial coronary angiography
Correlation Between NLR and Other Inflammatory Markers (PLR, CRP, HDL-Cholesterol)
This outcome assesses the relationship between the NLR and other laboratory markers of inflammation and cardiovascular risk, including platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), and HDL-cholesterol levels.
Measured: Within 48 hours of hospital admission
Correlation Between NLR and Peak Troponin Levels
This outcome evaluates the correlation between baseline NLR and peak troponin levels as a surrogate marker for myocardial infarction size.
Measured: During hospitalization (within first 5 days of admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACS (Acute Coronary Syndrome)Studies 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
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Centre Mother Teresa
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Andi Rroku, MD, Principal investigator, Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin FranklinAlban Dibra, Prof. Dr, Phd, Study director, University of Medicine, TiranaMartiola Kola, MD, Principal investigator, University of Medicine, Tirana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026708
- Sponsor's protocol ID
- 3232
- Acronym
- TIRANA (ACS)
- Status last verified
- Sep 2025
- First submitted
- 10 Jun 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Investigation of Residual Inflammation After Non-ST/ ST Elevation Acute Coronary Syndrome - TIRANA (ACS) Prospective REGISTRY
- ClinicalTrials.gov ID
- NCT07026708
- Acronym / sponsor ID
- TIRANA (ACS) / 3232
- Conditions
- ACS (Acute Coronary Syndrome), Myocardial Infarction (MI), Myocardial Inflammation, Inflammation Biomarkers, NSTEMI - Non-ST Segment Elevation MI, STEMI
- Keywords
- Residual inflammation, Myocardial infarction, Percutaneous Coronary Intervention, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University Hospital Centre Mother TeresaUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 18 Jun 2025 (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 prospective observational study aims to evaluate the prognostic significance of the neutrophil-to-lymphocyte ratio (NLR) as a predictor of mortality in patients following an episode of Acute Coronary Syndrome (ACS). Despite advancements in interventional cardiology and medical therapy, mortality remains significant in post-ACS patients, and early risk stratification is essential for optimizing outcomes.
Recent studies have suggested that systemic inflammatory markers, such as NLR, are associated with adverse cardiovascular events. It is an easily obtainable and cost-effective laboratory parameter derived from a routine complete blood count. However, its value as an independent predictor of mortality post-ACS has not yet been fully established in our population.
The study will include patients aged, admitted with a confirmed diagnosis of ACS (STEMI or Non-STEMI) and treated with percutaneous coronary intervention (PCI). NLR values will be measured from the first blood draw upon hospital admission, 24 and 48 hours post PCI. Patients will be followed up for up to 6 months after discharge through telephone interviews .
First, primary outcomes of the study will be the association between NLR values and mortality (all cause mortality and cardiovascular mortality), MACE (MACE was defined as the composite of all-cause mortality, cardiac death, unplanned revascularization, non-fatal myocardial infarction that was attributable and not related to stent failure or unplanned revascularization not related to stent failure) within 6 months post-ACS.
Secondary outcomes will include:
- Differences in mean NLR between STEMI and NSTEMI patients.
- Association between elevated NLR and the presence of multivessel coronary artery disease on angiography.
- Correlation of NLR with other biomarkers, including the platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), high-density lipoprotein (HDL) cholesterol, and maximum troponin levels (as an indicator of myocardial infarction size)
This study aims to contribute to the identification of easily accessible and cost-efficient biomarkers that can aid clinicians in early risk stratification of ACS survivors. A strong correlation between high NLR values and increased post-discharge mortality would suggest that inflammation plays a key role in patient prognosis and could potentially influence post-ACS management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Coronary Syndrome Patients | – | –Data Collection: General patient information, diagnosis, comorbidities, CRP levels, neutrophil and lymphocyte counts, thrombocyte count, HDL cholesterol, LDL cholesterol, and complications (electrical and mechanical) will be collected from the medical records in the cardiology department of our main tertiary hospital "Mother Teresa Hospital". Angiographic data and treatment information will be gathered from standard coronary angiography reports used at our cardiac catheterization laboratories. The follow-up form used for telephone interviews with patients is based on standardized instruments, including the WHO Rose Angina Questionnaire, Seattle Angina Questionnaire, EQ-5D-5L, MacNew Heart Disease Health-Related Quality of Life Questionnaire, McGill Pain Questionnaire, and the MRC Dyspnoea Scale. Patient status will be evaluated at 24 hours, 48 hours, and 6 months after the onset of symptoms. The symptom onset time will be obtained from medical records documented upon patient referral. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General patient information, diagnosis, comorbidities, CRP levels, neutrophil and lymphocyte counts, thrombocyte count, HDL cholesterol, LDL cholesterol, and complications (electrical and mechanical) will be collected from the medical records in the cardiology department of our main tertiary hospital "Mother Teresa Hospital". Angiographic data and treatment information will be gathered from standard coronary angiography reports used at our cardiac catheterization laboratories. The follow-up form used for telephone interviews with patients is based on standardized instruments, including the WHO Rose Angina Questionnaire, Seattle Angina Questionnaire, EQ-5D-5L, MacNew Heart Disease Health-Related Quality of Life Questionnaire, McGill Pain Questionnaire, and the MRC Dyspnoea Scale. Patient status will be evaluated at 24 hours, 48 hours, and 6 months after the onset of symptoms. The symptom onset time will be obtained from medical records documented upon patient referral.
Key inclusion criteria (1 listed)
- All patients (undergoing PCI, aged 18-85 years) presenting to the cardiology department or/and the cardiology intensive care unit with a diagnosis of ACS
Key exclusion criteria (1 listed)
- Patients presenting to the cardiology department or/and the cardiology intensive care unit with diagnoses other than ACS and/or UA. Patients who died before undergoing PCI and those who did not provide a contact number.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: 6 months post-ACS with a potential prolonged period of roughly 12 months
Association Between Neutrophil-to-Lymphocyte Ratio (NLR) and Mortality (all cause mortality and cardiovascular mortality), MACE (MACE was defined as the composite of all-cause mortality, cardiac death, unplanned revascularization, non-fatal myocardial infarction that was attributable and not related to stent failure or unplanned revascularization not related to stent failure) in Post-Acute Coronary Syndrome (ACS) Patients . This outcome assesses the predictive value of NLR levels for mortality within 6 months following an ACS event.
Mortality (all cause mortality and cardiovascular mortality)
Time frame: 6 months post-ACS with a potential prolonged period of roughly 12 months
Mortality (all cause mortality and cardiovascular mortality) in Post-Acute Coronary Syndrome (ACS) Patients .
MACE (Major Acute Coronary Events)
Time frame: 6 months post-ACS with a potential prolonged period of roughly 12 months
MACE was defined as the composite of all-cause mortality, cardiac death, unplanned revascularization, non-fatal myocardial infarction that was attributable and not related to stent failure or unplanned revascularization not related to stent failure in Post-Acute Coronary Syndrome (ACS) Patients .
4 secondary outcomes
Difference in Mean NLR Between STEMI and NSTEMI Patients
Time frame: At hospital admission
Association Between High NLR and Presence of Multivessel Coronary Artery Disease
Time frame: During initial coronary angiography
Correlation Between NLR and Other Inflammatory Markers (PLR, CRP, HDL-Cholesterol)
Time frame: Within 48 hours of hospital admission
Correlation Between NLR and Peak Troponin Levels
Time frame: During hospitalization (within first 5 days of admission)
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 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for ACS (Acute Coronary Syndrome)
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
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.
Andi Rroku, MD principal investigator
Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin
Alban Dibra, Prof. Dr, Phd study director
University of Medicine, Tirana
Martiola Kola, MD principal investigator
University of Medicine, Tirana
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 ACS (Acute Coronary Syndrome) and Myocardial Infarction (MI), run by University Hospital Centre Mother Teresa at 1 site in Albania.
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 1 inclusion and 1 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 30 Sep 2025. 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 Albania. 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 Martiola Kola, MD (003553410998, martiola.kola@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil-to-Lymphocyte Ratio (NLR) (time frame: 6 months post-ACS with a potential prolonged period of roughly 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025.