Ventricular Arrhythmias in Acute Myocardial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ventricular Arrhythmia, Acute Myocardial Infarction (AMI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ventricular Arrhythmias in the Acute Phase of Myocardial Infarction: ADVERSE MI Study
Overview
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.
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).
Primary outcome measures
- Post-discharge mortality [Time frame: through study completion, an average of 2 years]
Secondary outcome measures (9)
- Baseline demographic and clinical characteristics at inclusion [Time frame: At baseline]
- Number of participants fot each type of myocardial infarction [Time frame: At baseline]
- Number of participants with each ventricular arrhythmia characteristic and management strategy during index hospitalization [Time frame: 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]
- Number of participants with wearable cardioverter-defibrillator utilization [Time frame: At baseline]
- Rate of recurrent myocardial infarction after hospital discharge [Time frame: 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]
- Rate of defibrillator implantation during hospitalization and after hospital discharge [Time frame: through study completion, an average of 2 years]
- Number of participants, incidence, characteristics, and management of electrical storms [Time frame: At baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 8 centers
- University hospital of Caen — Caen
- University hospital of Dijon — Dijon
- University hospital of Grenoble — Grenoble
- Hopital Européen Georges Pompidou — Paris
- Hospital of Pau — Pau
- University hospital of Poitiers — Poitiers
- University hospital of Saint Etienne — Saint-Etienne
- University hospital of Tours — Tours
Identifiers
NCT: NCT07517523 · ADVERSE MI STUDY