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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
Up to 5 years
2

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)

Time frame
up to five years

Secondary outcomes

Other outcomes

Sponsors and contacts

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