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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.

12. september 2026 opdateret af: Asmaa talaat, Assiut University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Anslået)

400

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Hamdy Shams Eldin Mohamed, Professor of Cardiology
  • Telefonnummer: +201065601161
  • E-mail: hamdyshams@aun.edu.eg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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).
Diagnostisk test: Total Ischemic Time Evaluation
Measurement and documentation of the time duration from symptom onset to primary PCI balloon inflation/device placement.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Contrast-Induced Nephropathy (CIN)
Tidsramme: 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.
Up to 72 hours post-procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serial Variations of Renal Biomarkers and Short-Term Clinical Outcomes
Tidsramme: Baseline, 24, 48, and 72 hours post-procedure, up to index hospital discharge (up to 7 days)
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.
Baseline, 24, 48, and 72 hours post-procedure, up to index hospital discharge (up to 7 days)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assiut University

Efterforskere

  • Ledende efterforsker: Hamdy Shams Eldin Mohamed, Professor of Cardiology, Cardiology Department, Faculty of Medicine, Assiut University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

15. juli 2028

Studieafslutning (Anslået)

25. august 2028

Datoer for studieregistrering

Først indsendt

12. september 2026

Først indsendt, der opfyldte QC-kriterier

12. september 2026

Først opslået (Faktiske)

17. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. september 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • total ischemic time CIN

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

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