Dangerous heart rhythms after a heart attack
Ventricular Arrhythmias in the Acute Phase of Myocardial Infarction: ADVERSE MI Study
This study will see how survival and treatment differ for adults who develop sustained ventricular tachycardia or ventricular fibrillation during a heart attack, comparing events that occur within 48 hours to those that occur later.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 8 sites (Caen and 7 other locations) |
| Trial ID | NCT07517523 on ClinicalTrials.gov |
What this trial studies
This is a multicenter retrospective chart review of adults with sustained ventricular arrhythmias occurring during the acute phase of an acute myocardial infarction at several French university hospitals between January 1, 2012 and April 14, 2024. Investigators will collect clinical characteristics, management steps (including device therapy and other treatments), and outcomes up to and after hospital discharge. The primary analysis compares post-discharge mortality for arrhythmias occurring within 48 hours versus after 48 hours of the index infarct. Sensitivity analyses will examine differences by arrhythmia subtype (ventricular fibrillation versus ventricular tachycardia), presence of concomitant heart failure, and ST-elevation versus non-ST-elevation myocardial infarction.
Who should consider this trial
Good fit: Adults (age ≥18) treated for an acute myocardial infarction between January 1, 2012 and April 14, 2024 who experienced a sustained ventricular tachycardia or ventricular fibrillation during the index hospitalization before discharge.
Not a fit: Patients who did not experience a sustained ventricular arrhythmia during the acute MI, who were treated only as outpatients, or who are under 18 would not be included and are unlikely to directly benefit from this analysis.
Why it matters
Potential benefit: If successful, the results could clarify timing-related risks and help refine recommendations for post-MI management such as timing of ICD placement to improve survival decisions.
How similar studies have performed: Previous evidence is limited and guideline recommendations about ICD placement after post-MI ventricular fibrillation rely on sparse retrospective data, so this area remains under-tested without definitive prospective trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Caen and 7 other locations
- University hospital of Caen — Caen, France (Recruiting)
- University hospital of Dijon — Dijon, France (Recruiting)
- University hospital of Grenoble — Grenoble, France (Recruiting)
- Hopital Européen Georges Pompidou — Paris, France (Recruiting)
- Hospital of Pau — Pau, France (Recruiting)
- University hospital of Poitiers — Poitiers, France (Recruiting)
- University hospital of Saint Etienne — Saint-Etienne, France (Recruiting)
- University hospital of Tours — Tours, France (Recruiting)
Study contacts
- Principal investigator: Rodrigue Garcia, MD; PhD — Cardiology department and CIC 1402; University Hospital of Poitiers
- Study coordinator: Véronique Le Marcis
- Email: veronique.le-marcis@chu-poitiers.fr
- Phone: +33 5 49444084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.