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Studies

Interventional Recruiting

NCT07545512 on ClinicalTrials.gov

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

Official title: ODISSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY (ODISSEY-SCD

  • Sponsor: Centre Hospitalier Universitaire de Clermont-Ferrand
  • Enrollment: 400 (Estimated)
  • Study start: 2026-10-01 (Estimated)
  • Primary completion: 2033-07-01 (Estimated)
  • Study completion: 2033-07-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Other

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

Intervention / Treatment

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

Primary Outcome Measures

  • Occuirence of sudden cardiac death in patients with ischemic heart disease and moderately impaired left ventricular ejection fraction (between 35 and 50%). (Up to 5 years)
    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)
  • Markers to predict the risk of sudden cardiac death or malignant ventricular arrhytmia (up to five years)
    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)

Countries

France

Locations and Investigators

  • CHU Amiens, Amiens, France (Not yet recruiting)
    • Maciej KUBALA (Principal Investigator)
  • CHU Brest, Brest, France (Not yet recruiting)
    • Jacques MANSOURATI (Principal Investigator)
  • CHU Caen, Caen, France (Not yet recruiting)
    • Laure CHAMP-RIGOT (Principal Investigator)
  • CHU Clermont-Ferrand, Clermont-Ferrand, France (Not yet recruiting)
    • Lise Laclautre
    • Romain ESCHALIER, PU-PH (Principal Investigator)
  • CHRU Lille, Lille, France (Recruiting)
    • Christelle MARQUIE (Principal Investigator)
  • HCL - Hôpital de la Croix-Rousse, Lyon, France (Not yet recruiting)
    • Paul CHARLES (Principal Investigator)
  • HCL - Hôpital Pierre Wertheimer, Lyon, France (Not yet recruiting)
    • Francis BESSIERE (Principal Investigator)
  • CHU Nancy, Nancy, France (Not yet recruiting)
    • Christian De CHILLOU (Principal Investigator)
  • CHU Nantes Hôpital Nord Laennec, Nantes, France (Recruiting)
    • Vincent PROBST (Principal Investigator)
  • APHP - Hôpital européen Georges-Pompidou, Paris, France (Not yet recruiting)
    • Eloi MARIJON (Principal Investigator)
  • CHU de Poitiers, Poitiers, France (Not yet recruiting)
    • Rodrigue GARCIA (Principal Investigator)
  • CHU Saint Etienne, Saint-Etienne, France (Not yet recruiting)
    • Antoine DA COSTA (Principal Investigator)
  • CHU Strasbourg, Strasbourg, France (Recruiting)
    • Laurence JESEL-MOREL (Principal Investigator)
  • CHU Toulouse, Toulouse, France (Not yet recruiting)
    • Philippe MAURY (Principal Investigator)
  • CH Vichy, Vichy, France (Not yet recruiting)
    • Clément QUINERO (Principal Investigator)

Study Officials