Ventricular Arrhythmias in Acute Myocardial Infarction (ADVERSE-MI)

May 26, 2026 updated by: Poitiers University Hospital

Ventricular Arrhythmias in the Acute Phase of Myocardial Infarction: ADVERSE MI Study

Ventricular arrhythmias are a serious complication of myocardial infarction. The aim of this study is to provide reliable data on the management and mortality associated with ventricular arrhythmia in the setting of acute myocardial infarction.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Ventricular arrhythmias remain a major complication during the acute phase of myocardial infarction. The 2022 European guidelines on ventricular arrhythmias recommend implantable cardioverter-defibrillator (ICD) placement for secondary prevention when ventricular fibrillation occurs ≥ 48 hours after the infarct. Yet this recommendation rests on limited evidence. We therefore conduct a multicentre retrospective study to characterise the clinical profile, management, and prognosis of sustained ventricular arrhythmias (ventricular tachycardia and ventricular fibrillation) arising in the acute myocardial infarction setting.

The primary objective of this study is to evaluate post-discharge mortality in patients who develop an arrhythmia either within 48 hours of, or more than 48 hours after, an acute myocardial infarction. Sensitivity analyses will further examine outcomes according to the arrhythmia subtype (ventricular fibrillation vs ventricular tachycardia), the presence of concomitant heart failure, and the myocardial-infarction phenotype (STEMI vs NSTEMI).

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Caen, France
        • Recruiting
        • University hospital of Caen
      • Dijon, France
        • Recruiting
        • University Hospital of Dijon
      • Grenoble, France
        • Recruiting
        • University hospital of Grenoble
      • Paris, France
        • Recruiting
        • Hôpital Européen Georges Pompidou
      • Pau, France
        • Recruiting
        • Hospital of Pau
      • Poitiers, France
        • Recruiting
        • University hospital of Poitiers
      • Saint-Etienne, France
        • Recruiting
        • University Hospital of Saint Etienne
      • Tours, France
        • Recruiting
        • University hospital of Tours

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All included individuals will be consecutive patients who developed a sustained ventricular arrhythmia during the acute phase of a myocardial infarction between January 1, 2012, and April 14, 2024.

Description

Inclusion Criteria:

  • ≥ 18 years
  • Acute myocardial infarction
  • Sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation) at the acute phase of an acute myocardial infarction (before hospital discharge)
  • Between January 1, 2012 and April 14, 2024

Exclusion Criteria:

  • None

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
Ventricular arrhythmia
patients who developed a sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation) during the acute phase of myocardial infarction, i.e., from infarct onset to hospital discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-discharge mortality
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline demographic and clinical characteristics at inclusion
Time Frame: At baseline
This outcome is the characterization of the study population at baseline, including demographic, and clinical-related variables collected at the time of myocardial infarction.
At baseline
Number of participants fot each type of myocardial infarction
Time Frame: At baseline
Includes revascularization strategy and other therapeutic management measures implemented during the index hospitalization.
At baseline
Number of participants with each ventricular arrhythmia characteristic and management strategy during index hospitalization
Time Frame: At baseline
Descriptive summary of ventricular arrhythmia presentation and in-hospital management, including arrhythmia type, timing of occurrence, recurrence, and therapeutic interventions.
At baseline
In-hospital mortality
Time Frame: From admission until the date of death or hospital discharge, whichever came first, assessed up to 28 days
proportion of patients who die during their hospital stay, before discharge
From admission until the date of death or hospital discharge, whichever came first, assessed up to 28 days
Number of participants with wearable cardioverter-defibrillator utilization
Time Frame: At baseline
At baseline
Rate of recurrent myocardial infarction after hospital discharge
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
Rate of recurrent ventricular arrhythmias after hospital discharge
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
Rate of defibrillator implantation during hospitalization and after hospital discharge
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
Number of participants, incidence, characteristics, and management of electrical storms
Time Frame: At baseline
At baseline

Collaborators and Investigators

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

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Rodrigue Garcia, MD; PhD, Cardiology department and CIC 1402; University Hospital of Poitiers

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)

June 20, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVERSE MI STUDY

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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