Different Reperfusion Timing and Ventricular Arrhythmias in STEMI Patients

Completed

• Conditions: ST Elevation Myocardial Infarction; Arrhythmia Ventricular

• Registration Number: NCT04660474
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

The aim of this study was to investigate the association between different reperfusion timing and ventricular arrhythmias (VAs) to provide evidence for clinical decision-making for patients with ST-segment elevation myocardial infarction (STEMI). All the participants included in the study were diagnosed with STEMI according to the 4th universal definition of myocardial infarction, with a follow-up of 1, 6, 12 months, respectively. Symptom onset-to-reperfusion timing (SO2RT) and 24h-dynamic electrocardiogram parameters were recorded to compare different SO2RT and VAs during 3 follow-up visits.

Detailed Description

It is Class I recommendation that STEMI require emergency revascularization with no delay. However, arrhythmias after acute myocardial infarction (AMI), particularly VAs, also occur in the early post-MI phase, leading to increased mortality. Previous studies have shown benefits of late reperfusion to electrical stability. The aim of this study was to investigate the association between different reperfusion timing and VAs to provide evidence for clinical decision-making for STEMI. In this multicenter, prospective, observational study, STEMI participants from July 2019 to December 2020 confirmed according to the 4th universal definition of myocardial infarction were enrolled, with a follow-up of 1, 6, 12 months, respectively. SO2RT was defined as the time interval between symptom onset and reperfusion timing which referred to the timing when coronary angiography showed Thrombolysis In Myocardial Infarction (TIMI) blood flow level 2\~3 immediately after percutaneous coronary intervention (PCI). The primary end point was VAs on 24h-dynamic electrocardiogram. Secondary outcomes included a composite of death from coronary heart disease, fetal of non-fetal ischemic stroke, revascularization, or chest pain requiring readmission.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-09
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 517

Inclusion Criteria

• STEMI patients undergoing coronary angiography and PCI;
• can complete 3 follow-up visits well.

Exclusion Criteria

• without PCI;
• undergoing thrombolytic therapy;
• mental diseases;
• renal failure;
• stroke sequelae;
• tumor and a history of revascularization.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAs	12 months	The incidence of ventricular arrhythmias on 24h-dynamic electrocardiogram.

Secondary Outcome Measures

Name	Time	Method
Death from coronary heart disease	12 months	The incidence of death from coronary heart disease during follow-ups.
Chest pain requiring readmission	12 months	The incidence of chest pain requiring readmission during follow-ups.
Fetal of non-fetal ischemic stroke	12 months	The incidence of fetal of non-fetal ischemic stroke during follow-ups.
Revascularization	12 months	The incidence of revascularization during follow-ups.

Trial Locations

Locations (1)

the First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China