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NCT Number: NCT07517523

Ventricular Arrhythmias in Acute Myocardial Infarction

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.

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Key information

Conditions

Ventricular Arrhythmia Acute Myocardial Infarction (AMI) Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Arrest Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Tachycardia Tachycardia, Ventricular Vascular Diseases Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital of Caen, Caen, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Post-discharge mortality

    Time frame: through study completion, an average of 2 years

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. Number of participants with wearable cardioverter-defibrillator utilization

    Time frame: At baseline

  6. Rate of recurrent myocardial infarction after hospital discharge

    Time frame: through study completion, an average of 2 years

  7. Rate of recurrent ventricular arrhythmias after hospital discharge

    Time frame: through study completion, an average of 2 years

  8. Rate of defibrillator implantation during hospitalization and after hospital discharge

    Time frame: through study completion, an average of 2 years

  9. Number of participants, incidence, characteristics, and management of electrical storms

    Time frame: At baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Véronique Le Marcis

CONTACT

[email protected]

+33 5 49444084

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: ADVERSE-MI

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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