Ventricular ArrhythmiaADVERSE-MINCT07517523
Ventricular Arrhythmias in Acute Myocardial Infarction
An observational study of Ventricular Arrhythmia and Acute Myocardial Infarction (AMI), run by Poitiers University Hospital at 8 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmia, Acute Myocardial Infarction (AMI)
- How many people
- 500 participants
- Where
- 8 sitesFrance
- Study dates
- 20 Jun 2025to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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
Who cannot join
- None
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
University hospital of Caen
Caen
- Recruiting
University hospital of Dijon
Dijon
- Recruiting
University hospital of Grenoble
Grenoble
- Recruiting
Hopital Européen Georges Pompidou
Paris
- Recruiting
Hospital of Pau
Pau
- Recruiting
University hospital of Poitiers
Poitiers
- Recruiting
University hospital of Saint Etienne
Saint-Etienne
- Recruiting
University hospital of Tours
Tours
About this study
Official title: 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.
Read the 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).
- Keywords
- ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, ventricular fibrillation, ventricular tachycardia, cardiac arrest, implantable cardioverter defibrillator
- Medical subject headings
- ST Elevation Myocardial Infarction, Ventricular Fibrillation, Tachycardia, Ventricular, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Post-discharge mortality
Measured: through study completion, an average of 2 years
Secondary outcomes (9)
Baseline demographic and clinical characteristics at inclusion
This outcome is the characterization of the study population at baseline, including demographic, and clinical-related variables collected at the time of myocardial infarction.
Measured: At baseline
Number of participants fot each type of myocardial infarction
Includes revascularization strategy and other therapeutic management measures implemented during the index hospitalization.
Measured: At baseline
Number of participants with each ventricular arrhythmia characteristic and management strategy during index hospitalization
Descriptive summary of ventricular arrhythmia presentation and in-hospital management, including arrhythmia type, timing of occurrence, recurrence, and therapeutic interventions.
Measured: At baseline
In-hospital mortality
proportion of patients who die during their hospital stay, before discharge
Measured: 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
Measured: At baseline
Rate of recurrent myocardial infarction after hospital discharge
Measured: through study completion, an average of 2 years
Rate of recurrent ventricular arrhythmias after hospital discharge
Measured: through study completion, an average of 2 years
Rate of defibrillator implantation during hospitalization and after hospital discharge
Measured: through study completion, an average of 2 years
Number of participants, incidence, characteristics, and management of electrical storms
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 Jun 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodrigue Garcia, MD; PhD, Principal investigator, Cardiology department and CIC 1402; University Hospital of Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517523
- Sponsor's protocol ID
- ADVERSE MI STUDY
- Acronym
- ADVERSE-MI
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Arrhythmias in the Acute Phase of Myocardial Infarction: ADVERSE MI Study
- ClinicalTrials.gov ID
- NCT07517523
- Acronym / sponsor ID
- ADVERSE-MI / ADVERSE MI STUDY
- Keywords
- ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, ventricular fibrillation, ventricular tachycardia, cardiac arrest, implantable cardioverter defibrillator
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-discharge mortality
Time frame: through study completion, an average of 2 years
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
Related trials for Ventricular Arrhythmia
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EDEN Intracardiac Electrogram Recording and Classifying System
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Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
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Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodrigue Garcia, MD; PhD principal investigator
Cardiology department and CIC 1402; University Hospital of Poitiers
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrhythmia and Acute Myocardial Infarction (AMI), run by Poitiers University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Véronique Le Marcis (+33 5 49444084, veronique.le-marcis@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-discharge mortality (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.