Different Reperfusion Timing and Ventricular Arrhythmias in STEMI Patients

May 21, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

Association of Reperfusion Timing With Short- and Medium-term Ventricular Arrhythmias in Patients With ST-segment Elevation Myocardial Infarction: A Prospective Observational Study

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

517

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

A prospective cohort study was designed to investigate the effects of different reperfusion timing on VAs in STEMI patients. During the patients' follow-up, 24h-dynamic electrocardiography, echocardiography were required to record the incidence of primary outcome and other parameters. Information on SO2RT, demographic characteristics, hypertension, diabetes and dyslipidemia history, drug use, smoking, drinking, biochemical indexes and coronary lesions were also collected.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Early reperfusion group
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAs
Time Frame: 12 months
The incidence of ventricular arrhythmias on 24h-dynamic electrocardiogram.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Huai'an First People's Hospital
The Affiliated Hospital of Hangzhou Normal University
The Affiliated Jiangning Hospital of Nanjing Medical University

Investigators

  • Study Director: Liansheng Wang, Doctor, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VERY-STEMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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