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Different Reperfusion Timing and Ventricular Arrhythmias in STEMI Patients

N

Nanjing Medical University

Status

Completed

Conditions

ST Elevation Myocardial Infarction
Arrhythmia Ventricular

Study type

Observational

Funder types

Other

Identifiers

NCT04660474
VERY-STEMI

Details and patient eligibility

About

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.

Full 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.

Enrollment

517 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

517 participants in 3 patient groups

Early reperfusion group
Description:
All patients hospitalized and diagnosed as STEMI according to the 4th universal definition of myocardial infarction underwent coronary angiography and PCI treatment. Patients with SO2RT\<24 hours were assigned to Early reperfusion group.
Intermediate reperfusion group
Description:
All patients hospitalized and diagnosed as STEMI according to the 4th universal definition of myocardial infarction underwent coronary angiography and PCI treatment. Patients with SO2RT ranging from 24 hours to 7days were assigned to Intermediate reperfusion group.
Late reperfusion group
Description:
All patients hospitalized and diagnosed as STEMI according to the 4th universal definition of myocardial infarction underwent coronary angiography and PCI treatment. Patients with SO2RT\>7days were assigned to Late reperfusion group.

Trial contacts and locations

1

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Central trial contact

Sibo Wang; Liansheng Wang, Doctor

Data sourced from clinicaltrials.gov

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