NCT07826572Not yet recruiting
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.
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 12 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 15 Jul 2028
- Lead sponsor
- Assiut University
- Diseases
- Coronary artery disease
- NCT number
- NCT07826572
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 Oct 2026 to the primary completion date, 15 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to iodinated contrast media within the past 7 days, or scheduled elective contrast procedures within the subsequent 72 hours.
- Known active treatment with high-potency nephrotoxic drugs within the 48 hours prior to admission (e.g., cisplatin, high-dose aminoglycosides, amphotericin B).
Other illness
- Active pregnancy, ongoing breastfeeding, or severe non-cardiac co-morbidities associated with a life expectancy \<30 days (e.g., advanced terminal malignancies)
Lab values
- Pre-existing end-stage renal disease (ESRD) requiring long-term peritoneal dialysis or hemodialysis, or an admission baseline eGFR \<15 mL/min/1.73m2.
- 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.
Other
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Who the study is looking for
- Inclusion Criteria:
- 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.
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Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.