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NCT07826572

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.

Sponsor: Assiut University

View on ClinicalTrials.gov

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). 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2026-10-01

Completion Date

2028-08-25

Last Updated

2026-09-17

Healthy Volunteers

Yes

Conditions

ST Elevation (STEMI) Myocardial Infarction Contrast Induced Nephropathy (CIN)Acute Kidney Injury

Interventions

DIAGNOSTIC_TEST

Total Ischemic Time Evaluation

Measurement and documentation of the time duration from symptom onset to primary PCI balloon inflation/device placement.

Inclusion Criteria: * Inclusion Criteria: 1. Patients aged \>=18 years at the time of presentation. 2. 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). 3. Selection for immediate mechanical reperfusion via emergency primary percutaneous coronary intervention (PPCI) according to current guidelines. 4. 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. 5. 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. . Exclusion Criteria:  1. Pre-existing end-stage renal disease (ESRD) requiring long-term peritoneal dialysis or hemodialysis, or an admission baseline eGFR \<15 mL/min/1.73m2. 2. Prior exposure to iodinated contrast media within the past 7 days, or scheduled elective contrast procedures within the subsequent 72 hours. 3. 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. 4. Known active treatment with high-potency nephrotoxic drugs within the 48 hours prior to admission (e.g., cisplatin, high-dose aminoglycosides, amphotericin B). 5. Active pregnancy, ongoing breastfeeding, or severe non-cardiac co-morbidities associated with a life expectancy \<30 days (e.g., advanced terminal malignancies)