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Not yet recruitingNCT07826572Updated Sep 17, 2026

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 in ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN) and Acute Kidney Injury, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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.

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).

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Eligibility criteria

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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).

    Diagnostic Test: Total Ischemic Time Evaluation

Interventions

  • Diagnostic testTotal Ischemic Time Evaluation

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

05

What researchers measure

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)

06

Study locations

No study locations are listed for this record.

07

References and documents

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 28886621 ↗
  • LURA A, BOTTI GD. [Contrast radiographic study of heart valve calcifications]. Radiol Med. 1949 Nov;35(11):859-76. No abstract available. Italian. PubMed 15395837 ↗

Individual participant data

Plan to share: 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.

08

Registry details

Key details

Study ID
NCT07826572
Lead sponsor
Assiut University
Responsible party
Asmaa talaat (resident of cardiology , assiut universiy, Assiut University) — Principal investigator
First posted
Sep 17, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jul 15, 2028 (estimated)
Completion
Aug 25, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Asmaa Talaat Ibrahiem Mohamed, Resident of Cardiology
Contact
Asmaa.18313612@med.aun.edu.eg
+201069382042
Hamdy Shams Eldin Mohamed, Professor of Cardiology
Contact
hamdyshams@aun.edu.eg
+201065601161
Hamdy Shams Eldin Mohamed, Professor of Cardiology
principal investigator · Cardiology Department, Faculty of Medicine, Assiut University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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