ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVE… (NCT07545512) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
France400 participantsStarted 2026-07-01
Plain-language summary
Although advances in treatment and patient management have considerably improved post-infarction prognosis, the risk of sudden cardiac death remains a major concern. Sudden cardiac death (SCD) is defined as an unexpected death occurring within one hour of the onset of symptoms, often of arrhythmic origin. In patients who have survived a myocardial infarction, sudden death represents a persistent threat. This risk is often associated with complications such as left ventricular dysfunction, malignant ventricular arrhythmias, and structural alterations of the myocardium, all of which can favor the development of fatal cardiac events. Among the risk factors identified, reduced left ventricular ejection fraction, a history of ventricular arrhythmias and the presence of extensive scarring of the myocardium are particularly significant.
Assessing the risk of SCD in post-infarction patients is crucial to determining appropriate prevention strategies, such as implanting automatic implantable defibrillators (ICDs). Assessment tools are varied, but currently only left ventricular ejection fraction (LVEF) \< 35% is identified and validated. However, this risk stratification is unsatisfactory, particularly in view of SCD in patients with a history of myocardial infarction and a moderately impaired LVEF (between 35 and 50%). Although the initial treatment of myocardial infarction is essential for the patient's immediate survival, managing the risk of sudden death in the long term remains a major clinical challenge. A multiparametric approach is needed to optimize prognosis and prevent premature death in these patients.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients over 18 years of age
* Hospitalized for acute STEMI within 6 months (Type 1 myocardial infarction according to ESC recommendations, Thygesen EHJ 2018).
* Left ventricular ejection fraction between 35% and 50% at least 40 days after acute myocardial infarction (see above).
* Under optimal tolerated medical treatment.
* Covered by a social security scheme.
* Legally competent to give voluntary informed consent to participate in the study.
* Patient who will not participate in further studies involving an investigational drug or device until the end of the trial (i.e. 60 months). Participation in registries is authorized
Exclusion Criteria:
* Presence of a secondary prevention indication for implantation of an implantable automatic defibrillator (ICD)
* Presence of a pacemaker
* Administration of ventricular antiarrhythmic drugs other than beta-blockers (i.e. amiodarone, sotalol, flecainide)
* Patients with systemic diseases (cancer, liver failure or end-stage renal disease)
* Patients with assessed life expectancy \< 1 year.
* Age \> 80
* Adult patient under legal protection (guardianship, curatorship or other legal protection measure)
* The subject is pregnant or nursing or positive beta HCG for women of childbearing age
* Patient participating in another clinical research protocol involving an investigational drug or device within the last 30 days (participation in a registry is permitted at the same time).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is focused on people who've had a heart attack and have a left ventricular ejection fraction between 35 and 50% — does my ejection fraction actually fall in that range, and could I potentially be a candidate worth discussing with you?
2Since this trial is listed as 'not yet recruiting,' how soon might it open, and is there anything I should be doing in the meantime to prepare or stay informed about whether I might qualify?
3The study is trying to identify markers that predict sudden cardiac death risk in people like me — what kinds of tests or monitoring would likely be involved, and how would that fit with my current care routine?
4Since this is listed as Phase N/A and appears to be an observational or registry-type study, does that mean it's mainly tracking outcomes rather than testing a new treatment, and would participating change anything about the care I actually receive?
5Even if this trial isn't open yet or isn't the right fit for me, are there already established ways to assess my personal risk of sudden cardiac death given my history of heart attack and moderately reduced heart function?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occuirence of sudden cardiac death in patients with ischemic heart disease and moderately impaired left ventricular ejection fraction (between 35 and 50%).
Timeframe: Up to 5 years
2
Markers to predict the risk of sudden cardiac death or malignant ventricular arrhytmia