Total Ischemic Time Evaluation
Diagnostic TestMeasurement and documentation of the time duration from symptom onset to primary PCI balloon inflation/device placement.
NCT Number: NCT07826572
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
.
Exclusion criteria
<!-- -->
Measurement and documentation of the time duration from symptom onset to primary PCI balloon inflation/device placement.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Asmaa Talaat Ibrahiem Mohamed, Resident of Cardiology
CONTACT
Hamdy Shams Eldin Mohamed, Professor of Cardiology
CONTACT
Assiut University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07776288
Acute Myocardial Infarction (AMI), Cardiomyopathies
Santiago, Santiago Metropolitan, Chile
View Trial DetailsNCT07263282
Cardiovascular Diseases, Heart Diseases
Asyut, Egypt
View Trial DetailsNCT07277400
Cardiovascular Diseases, Heart Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT07129850
Cardiovascular Diseases, Heart Diseases
View Trial Details