MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

Myocardial Infarction Clinical Trial

— SMART-DEF  

Official title:

Multicenter randomiSed Trial on MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269692
• Other study ID #: 2023-A01353-42
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2030

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Christian de CHILLOU, MD, PhD
• Email: c.dechillou[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Implantable cardioverter-defibrillators (ICD) are currently recommended for the primary prevention of sudden cardiac death (SCD) in patients with a remote (>6 weeks) myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF).

Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Hence, the use of LVEF as a unique risk-stratifier of SCD results in a low proportion (17 to 31%) of appropriate ICD device therapy at 2 years. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. Therefore, the current implantation strategy of prophylactic ICDs, based on LVEF only, needs to be improved in post-MI patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1812
• Est. completion date: April 1, 2030
• Est. primary completion date: April 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years;

• Patients with a LVEF=35% assessed at least after a 40 to 90 days period (depending on the presence of coronary revascularization) following an index myocardial infarction;

• Left ventricular systolic impairment as defined by LVEF=35% by any current standard technique (echocardiogram, multiple gated acquisition scan, or MRI) within 2 months;

• Able and willing to comply with all pre-, post- and follow-up testing, and requirements;

• Use of maximum tolerated doses of ACE inhibitors (or Angiotensin II Receptor Blockers if intolerant of ACE) and Beta Blockers and MRA as per ESC guidelines;

• Person affiliated to or beneficiary of a social security plan

• Person informed about study organization and having signed the informed consent

Exclusion Criteria:

• History of cardiac arrest or sustained VT or VF unless within 48 hours of an acute myocardial infarction;

• Standard contraindications for cardiac LGE-MRI;

• Hypersensitivity to gadolinium-based contrast agent;

• Currently implanted permanent pacemaker and/or ICD;

• Patient refusal of ICD/ILR implantation;

• Currently implanted permanent pacemaker and/or ICD;

• Clinical indication for or Cardiac Resynchronization Therapy (CRT);

• Severe renal insufficiency defined by a glomerular filtration rate (GFR) < 30 mL/min/1.73m²;

• Recent PTCA (within 30 days) or CABG (within 90 days);

• Baseline NYHA functional class IV;

• Contraindication for ICD implantation according to current guidelines;

• Woman of childbearing age without effective contraception;

• Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the French Public Health Code.

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Infarction
• Myocardial Infarction
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• MRI screening
Cardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar
• Implantable Loop Recorder
Inplantation of the Implantable Loop Recorder (ILR) for the patients assigned to the experimental group
• Implantable Cardioverter Defibrillator
Inplantation of the Implantable Cardioverter Defibrillator (ICD) for the patients assigned to the control group, according to the current guidelines

Locations

Country	Name	City	State
France	CHRU Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Sudden Cardiac Death (SCD) during the follow-up period	Occurrence of SCD during the follow-up period, as defined by the World Health Organization in 10-ICD: death occurring within 24 hours from onset of symptoms.	72 months
Secondary	Total number of deaths during the follow-up period		72 months
Secondary	Total number of deaths from cardiovascular cause during the follow-up period		72 months
Secondary	Total number of SCD due to ventricular arrhythmia during the follow-up period		72 months
Secondary	Total number (per patient) of sustained VT episodes treated by the ICD or recorded by the ILR during the follow-up period		72 months
Secondary	Total number (per patient) of VF episodes treated by the ICD or recorded by the ILR during the follow-up period		72 months
Secondary	Total number of hospitalizations due to cardiovascular causes during the follow-up period		72 months
Secondary	Duration of hospitalizations due to cardiovascular causes during the follow-up period		72 months
Secondary	Total number of hospitalizations from any cause during the follow-up period		72 months
Secondary	Duration of hospitalizations from any cause during the follow-up period		72 months
Secondary	Quality of life assessed by the scoring obtained from EuroQol questionnaires (EQ-5D-5L) during the follow-up period		72 months
Secondary	Measurements of the estimated costs	Measurements of the estimated costs for the National Health Insurance System (NHIS) in the different arms of the trial	72 months
Secondary	Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences	Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences, LGE segmentation by cardiologists/radiologists as the ground truth	36 months
Secondary	Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences	Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences, LGE segmentation by cardiologists/radiologists as the ground truth	36 months
Secondary	Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar	Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar, using manually corrected segmentation by cardiologists/radiologists as the ground truth	36 months
Secondary	Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar	Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar, using manually corrected segmentation by cardiologists/radiologists as the ground truth	36 months