ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY

NCT07545512 | Not Yet Recruiting

• 1 other identifier: RBHP 2025 ESCHALIER
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Myocardial Infarction (MI); Sudden Cardiac Death Due to Cardiac Arrhythmia

Keywords

Sudden cardiac death in patients with ischemic heart disease and moderately impaired left ventricular ejection fraction (between 35 and 50%).

Outcome Measures

Primary Outcomes (2)

• Occuirence of sudden cardiac death in patients with ischemic heart disease and moderately impaired left ventricular ejection fraction (between 35 and 50%).

  Occurrence of sudden cardiac death or cardiovascular death or malignant ventricular arrhythmias (life-threatening ventricular arrhythmias: ventricular tachycardia (\>30s) or ventricular fibrillation) at 60 months follow-up (dependent variable)

  Up to 5 years

• Markers to predict the risk of sudden cardiac death or malignant ventricular arrhytmia

  Various markers recovered during the various initial examinations and during follow-up (clinical and remote monitoring) to predict the risk of SCD or malignant ventricular arrhythmia (independent variable)

  up to five years

Interventions

This study involved an auxillary CE-marked medical device (implantable holter for cardiac rhythm monitoring) DEVICE

This study involved an auxillary CE-marked medical device (implantable holter for cardiac rhythm monitoring) used outside its current recommendations and implanted for this study.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU Saint Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Romain ESCHALIER

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2033
• Study Completion (Estimated): May 1, 2033
• Last Updated: April 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

FR (2)