Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-26 @ 7:18 PM
Study NCT ID:
NCT07175259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relation of Total Ischemic Time to Repolarization Indices and Their Impact on Outcomes Among STEMI Patients Undergoing Primary PCI
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Relation of Total Ischemic Time to Repolarization Indices and Their Impact on Outcomes Among STEMI Patients Undergoing Primary PCI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1. Evaluate The impact of early versus late presentation on electrocardiographic ventricular repolarization indices.
2. To assess the association between repolarization indices among early, late presentation in relation to in-hospital ventricular arrhythmias, in-hospital MACE, and 6 months MACE.
2. To assess the association between repolarization indices among early, late presentation in relation to in-hospital ventricular arrhythmias, in-hospital MACE, and 6 months MACE.
Detailed Description:
ST-elevation myocardial infarction (STEMI) remains a time-critical cardiovascular emergency. Early reperfusion is essential to reduce myocardial necrosis, preserve ventricular function, and improve survival outcomes. However, delayed presentation remains a significant problem, especially in developing countries, leading to larger infarct sizes and worse clinical outcomes. (Park J, Choi KH, Lee JM, et al. 2019) Ventricular repolarization indices including QT interval ( Measured from the onset of the QRS complex (beginning of Q wave or R if no Q visible)To the end of the T wave returning to the isoelectric line ), QT dispersion (QTD) ( Calculated as: QTD = QT{max} - QT{min}), corrected QT interval (QTc) Calculated using Bazett's formula: QTc = {QT}/{sqrt{RR}. Corrected QT dispersion (cQTD or QTcd) Calculated as: cQTD = QTc{max}- QTc{min}.TPE/QT ratio, Calculated as: {TPE/QT Ratio} = {TPE}/{QT}, T peak-to-Tend interval (TPE) ( Measured from the peak of the T wave To the end of the T wave returning to the isoelectric line ), are non-invasive markers of electrical instability and myocardial injury. Prolongation of these indices has been associated with worse microvascular perfusion (including the no-reflow phenomenon (Abdelmeguid AE, Abdelhamid SM, Abdelhameed KM, et al. 2023) and lower myocardial blush grade \[MBG\]) (Liu X, Li Y, Li D, et al. 2021) and higher rates of major adverse cardiovascular events (MACE). (Çağdaş M, Rencüzoğulları İ, Karakoyun S, et al. 2018, Abdelmeguid AE, Abdelhamid SM, Abdelhameed KM, et al. 2023, Liu X, Li Y, Li D, et al. 2021) There is limited data assessing the direct relationship between early vs late presentation, repolarization indices measured before and after PCI, and subsequent outcomes in STEMI patients, particularly in our local population.
This study aims to fill this gap by investigating whether timing of presentation significantly affects repolarization indices and whether these indices can predict in-hospital and six-month clinical outcomes.
This study aims to fill this gap by investigating whether timing of presentation significantly affects repolarization indices and whether these indices can predict in-hospital and six-month clinical outcomes.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: