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.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Total Ischemic Time Evaluation

    Diagnostic test

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

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: STEMI Patients Undergoing Primary PCI1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
Baseline, 24, 48, and 72 hours post-procedure, up to index hospital discharge (up to 7 days)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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