ST Elevation (STEMI) Myocardial InfarctionNCT07826572
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
An observational study of ST Elevation (STEMI) Myocardial Infarction and Contrast Induced Nephropathy (CIN), run by Assiut University.
Trial summary
Contrast-Induced Nephropathy (CIN) is a serious complication following primary percutaneous coronary intervention (PCI) in patients presenting with acute ST-segment elevation myocardial infarction (STEMI). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN), Acute Kidney Injury
- What is being tested?
- Total Ischemic Time Evaluation
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 25 Aug 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive adult patients aged >=18 years presenting with acute ST-segment elevation myocardial infarction (STEMI) within 12 hours of symptom onset who undergo emergency primary percutaneous coronary intervention (PPCI) at Assiut University Heart Hospital.
Who may be able to join
- Patients aged >=18 years at the time of presentation.
- Definitive diagnosis of acute ST-segment elevation myocardial infarction (STEMI) presenting within 12 hours of symptom onset, characterized by typical ischemic symptoms (e.g., retrosternal chest pain) and electrocardiographic criteria: persistent ST-segment elevation >=1 mm in >=2 contiguous limb leads, or >=2 mm in >=2 contiguous precordial leads (V2-V3 thresholds: >=2.5 mm in men <40 years, >=2.0 mm in men >=40 years, and >=1.5 mm in women), or a validated new or presumably new left bundle branch block (LBBB).
- Selection for immediate mechanical reperfusion via emergency primary percutaneous coronary intervention (PPCI) according to current guidelines.
- A reliable and verifiable chronological timeline regarding the exact onset of chest pain or ischemic symptoms to ensure precise calculation of the total ischemic duration.
- Willingness to participate, demonstrated by signed, informed consent obtained from the patient or an authorized family representative prior to data collection under approved institutional protocols.
- .
Who cannot join
- <!-- -->
- Pre-existing end-stage renal disease (ESRD) requiring long-term peritoneal dialysis or hemodialysis, or an admission baseline eGFR <15 mL/min/1.73m2.
- Prior exposure to iodinated contrast media within the past 7 days, or scheduled elective contrast procedures within the subsequent 72 hours.
- Intentional pre-procedural administration of structured, high-volume intravenous fluid hydration regimens specifically designed to prevent contrast nephropathy (e.g., sodium bicarbonate protocols), which would confound baseline renal kinetics.
- Known active treatment with high-potency nephrotoxic drugs within the 48 hours prior to admission (e.g., cisplatin, high-dose aminoglycosides, amphotericin B).
- Active pregnancy, ongoing breastfeeding, or severe non-cardiac co-morbidities associated with a life expectancy <30 days (e.g., advanced terminal malignancies)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Asmaa Talaat Ibrahiem Mohamed, Resident of Cardiology contact
About this study
Contrast-Induced Nephropathy (CIN) is a serious complication following primary percutaneous coronary intervention (PCI) in patients presenting with acute ST-segment elevation myocardial infarction (STEMI). While the standard Mehran Risk Score uses static baseline clinical and procedural variables, it lacks dynamic parameters reflecting acute myocardial ischemic duration. Total ischemic time-from symptom onset to balloon inflation-drives systemic inflammation, forward cardiac failure, and renal hypoperfusion.
This prospective observational validation cohort study aims to evaluate the independent predictive value of Total Ischemic Time for CIN in acute STEMI patients undergoing primary PCI. Additionally, it investigates whether integrating total ischemic duration into the classic Mehran Risk Score enhances discrimination accuracy, net reclassification, and calibration performance for early pre-procedural risk stratification.
Read the detailed description
Background:
Contrast-Induced Nephropathy (CIN) remains one of the most significant complications following primary percutaneous coronary intervention (PPCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). The traditional Mehran Risk Score utilizes static baseline parameters (such as hypotension, IABP, CHF, age, anemia, diabetes, contrast volume, and baseline eGFR) to stratify CIN risk. However, it omits the duration of acute myocardial ischemia. Prolonged total ischemic time (the interval from symptom onset to first balloon inflation/device placement) triggers severe systemic inflammatory cascades, hemodynamic instability, and transient renal hypoperfusion, which may independently increase susceptibility to contrast-induced acute kidney injury.
Objectives:
To evaluate the independent predictive value of Total Ischemic Time for Contrast-Induced Nephropathy (CIN) in acute STEMI patients undergoing primary PCI.
To investigate whether integrating total ischemic duration into the classic Mehran Risk Score enhances its predictive performance, discrimination, calibration, and risk reclassification capacity.
Methods \& Procedure:
This prospective observational validation cohort study will recruit consecutive adult STEMI patients presenting to Assiut University Heart Hospital undergoing primary PCI within 12 hours of symptom onset. Total ischemic time (symptom-to-balloon time) will be precisely documented upon presentation. Baseline laboratory tests including serum creatinine, blood urea nitrogen (BUN), complete blood count (CBC), and blood glucose will be drawn prior to PCI. Serum creatinine will be re-evaluated at 24, 48, and 72 hours post-PCI to detect CIN (defined as an absolute increase in serum creatinine of ≥ 0.5 mg/dL or a relative increase of ≥ 25% from baseline within 48-72 hours post-contrast administration).
Statistical modeling will compare the performance of the classic Mehran Risk Score against a modified model incorporating total ischemic time using Area Under the Receiver Operating Characteristic Curve (AUROC), Net Reclassification Improvement (NRI), and Integrated Discrimination Improvement (IDI).
- Conditions
- ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN), Acute Kidney Injury
- Being tested
- Total Ischemic Time Evaluation
- Keywords
- Primary Percutaneous Coronary Intervention, Total Ischemic Time, Mehran Risk Score, STEMI, Contrast Induced Acute Kidney Injury
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Ischemic Time EvaluationDiagnostic test
Measurement and documentation of the time duration from symptom onset to primary PCI balloon inflation/device placement.
| Study group | Role | What they receive |
|---|---|---|
| STEMI Patients Undergoing Primary PCI | Consecutive adult STEMI patients presenting within 12 hours of symptom onset who undergo primary percutaneous coronary intervention (PPCI). Total ischemic time and baseline serum creatinine are measured, and renal function is monitored at 24, 48, and 72 hours post-PCI to evaluate Contrast-Induced Nephropathy (CIN). Receives: Diagnostic Test: Total Ischemic Time Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Contrast-Induced Nephropathy (CIN)
Incidence of CIN, defined as an absolute increase in serum creatinine of ≥ 0.5 mg/dL or a relative increase of ≥ 25% from baseline values measured at 24, 48, and 72 hours following primary PCI.
Measured: Up to 72 hours post-procedure
Secondary outcomes (1)
Serial Variations of Renal Biomarkers and Short-Term Clinical Outcomes
Tracking serial chronological variations of renal biomarker metrics including serum creatinine, blood urea nitrogen (BUN), and estimated glomerular filtration rate (eGFR) calculated via CKD-EPI 2021 equation, alongside the incidence of major adverse cardiovascular events (MACE), emergent renal replacement therapy, and short-term in-hospital mortality across total ischemic time sub-cohorts.
Measured: Baseline, 24, 48, and 72 hours post-procedure, up to index hospital discharge (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Jul 2028 (estimated)
- Study completion25 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST Elevation (STEMI) Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa talaat, Assiut University
- Investigators
- Hamdy Shams Eldin Mohamed, Professor of Cardiology, Principal investigator, Cardiology Department, Faculty of Medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826572
- Sponsor's protocol ID
- total ischemic time CIN
- Status last verified
- Jul 2026
- First submitted
- 12 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and maintain strict confidentiality in accordance with the study protocol and institutional review board guidelines. Only aggregated study results will be made available upon publication.
Publications
Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621LURA A, BOTTI GD. [Contrast radiographic study of heart valve calcifications]. Radiol Med. 1949 Nov;35(11):859-76. No abstract available. Italian.
PubMed 15395837
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT07826572
- Acronym / sponsor ID
- total ischemic time CIN
- Conditions
- ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN), Acute Kidney Injury
- Keywords
- Primary Percutaneous Coronary Intervention, Total Ischemic Time, Mehran Risk Score, STEMI, Contrast Induced Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 25 Aug 2028 (estimated)
- First posted
- 17 Sep 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.
Contrast-Induced Nephropathy (CIN) is a serious complication following primary percutaneous coronary intervention (PCI) in patients presenting with acute ST-segment elevation myocardial infarction (STEMI). While the standard Mehran Risk Score uses static baseline clinical and procedural variables, it lacks dynamic parameters reflecting acute myocardial ischemic duration. Total ischemic time-from symptom onset to balloon inflation-drives systemic inflammation, forward cardiac failure, and renal hypoperfusion.
This prospective observational validation cohort study aims to evaluate the independent predictive value of Total Ischemic Time for CIN in acute STEMI patients undergoing primary PCI. Additionally, it investigates whether integrating total ischemic duration into the classic Mehran Risk Score enhances discrimination accuracy, net reclassification, and calibration performance for early pre-procedural risk stratification.
Detailed description
Background:
Contrast-Induced Nephropathy (CIN) remains one of the most significant complications following primary percutaneous coronary intervention (PPCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). The traditional Mehran Risk Score utilizes static baseline parameters (such as hypotension, IABP, CHF, age, anemia, diabetes, contrast volume, and baseline eGFR) to stratify CIN risk. However, it omits the duration of acute myocardial ischemia. Prolonged total ischemic time (the interval from symptom onset to first balloon inflation/device placement) triggers severe systemic inflammatory cascades, hemodynamic instability, and transient renal hypoperfusion, which may independently increase susceptibility to contrast-induced acute kidney injury.
Objectives:
To evaluate the independent predictive value of Total Ischemic Time for Contrast-Induced Nephropathy (CIN) in acute STEMI patients undergoing primary PCI.
To investigate whether integrating total ischemic duration into the classic Mehran Risk Score enhances its predictive performance, discrimination, calibration, and risk reclassification capacity.
Methods \& Procedure:
This prospective observational validation cohort study will recruit consecutive adult STEMI patients presenting to Assiut University Heart Hospital undergoing primary PCI within 12 hours of symptom onset. Total ischemic time (symptom-to-balloon time) will be precisely documented upon presentation. Baseline laboratory tests including serum creatinine, blood urea nitrogen (BUN), complete blood count (CBC), and blood glucose will be drawn prior to PCI. Serum creatinine will be re-evaluated at 24, 48, and 72 hours post-PCI to detect CIN (defined as an absolute increase in serum creatinine of ≥ 0.5 mg/dL or a relative increase of ≥ 25% from baseline within 48-72 hours post-contrast administration).
Statistical modeling will compare the performance of the classic Mehran Risk Score against a modified model incorporating total ischemic time using Area Under the Receiver Operating Characteristic Curve (AUROC), Net Reclassification Improvement (NRI), and Integrated Discrimination Improvement (IDI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI Patients Undergoing Primary PCI | – | Diagnostic Test: Total Ischemic Time EvaluationConsecutive adult STEMI patients presenting within 12 hours of symptom onset who undergo primary percutaneous coronary intervention (PPCI). Total ischemic time and baseline serum creatinine are measured, and renal function is monitored at 24, 48, and 72 hours post-PCI to evaluate Contrast-Induced Nephropathy (CIN). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients aged >=18 years presenting with acute ST-segment elevation myocardial infarction (STEMI) within 12 hours of symptom onset who undergo emergency primary percutaneous coronary intervention (PPCI) at Assiut University Heart Hospital.
Key inclusion criteria (6 listed)
- .
Key exclusion criteria (6 listed)
- <!-- -->
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 |
|---|---|---|
| Total Ischemic Time EvaluationMeasurement and documentation of the time duration from symptom onset to primary PCI balloon inflation/device placement. | Diagnostic test | STEMI Patients Undergoing Primary PCI |
Primary outcome
Incidence of Contrast-Induced Nephropathy (CIN)
Time frame: Up to 72 hours post-procedure
Incidence of CIN, defined as an absolute increase in serum creatinine of ≥ 0.5 mg/dL or a relative increase of ≥ 25% from baseline values measured at 24, 48, and 72 hours following primary PCI.
1 secondary outcome
Serial Variations of Renal Biomarkers and Short-Term Clinical Outcomes
Time frame: Baseline, 24, 48, and 72 hours post-procedure, up to index hospital discharge (up to 7 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 17 Sep 2026.
- Background: PubMed 28886621Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
- Background: PubMed 15395837LURA A, BOTTI GD. [Contrast radiographic study of heart valve calcifications]. Radiol Med. 1949 Nov;35(11):859-76. No abstract available. Italian.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient privacy and maintain strict confidentiality in accordance with the study protocol and institutional review board guidelines. Only aggregated study results will be made available upon publication.
Related trials for ST Elevation (STEMI) Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
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.
Asmaa Talaat Ibrahiem Mohamed, Resident of Cardiology contact
Hamdy Shams Eldin Mohamed, Professor of Cardiology principal investigator
Cardiology Department, Faculty of Medicine, Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation (STEMI) Myocardial Infarction and Contrast Induced Nephropathy (CIN), run by Assiut University.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Asmaa Talaat Ibrahiem Mohamed, Resident of Cardiology (+201069382042, Asmaa.18313612@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Contrast-Induced Nephropathy (CIN) (time frame: Up to 72 hours post-procedure). 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 NCT07826572, which also lists 2 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 17 Sep 2026.