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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantable Loop Recorder | Experimental | Patients identified at very low-risk of VT/VF randomized to be implanted with an ILR (experimental strategy). Following randomization, these patients will be followed using remote ILR monitoring. |
|
| Implantable Cardioverter Defibrillator | Other | Patients identified at very low-risk of VT/VF randomized to be implanted with an ICD (reference strategy), which corresponds to the currently recommended treatment in post-MI patients with a LVEF ≤35% (European Society of Cardiology guidelines 2015) (Zeppenfeld et al., 2022). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI screening | Device | Cardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of deaths during the follow-up period | 72 months | |
| Total number of deaths from cardiovascular cause during the follow-up period | 72 months | |
| Total number of SCD due to ventricular arrhythmia during the follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian de CHILLOU, MD, PhD | Contact | c.dechillou@chru-nancy.fr | ||
| Guilaume DROUOT, PhD | Contact | g.drouot@chru-nancy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Nancy | Vandœuvre-lès-Nancy | 54511 | France |
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| Implantable Loop Recorder | Device | Inplantation of the Implantable Loop Recorder (ILR) for the patients assigned to the experimental group |
|
| Implantable Cardioverter Defibrillator | Device | Inplantation of the Implantable Cardioverter Defibrillator (ICD) for the patients assigned to the control group, according to the current guidelines |
|
| 72 months |
| Total number (per patient) of sustained VT episodes treated by the ICD or recorded by the ILR during the follow-up period | 72 months |
| Total number (per patient) of VF episodes treated by the ICD or recorded by the ILR during the follow-up period | 72 months |
| Total number of hospitalizations due to cardiovascular causes during the follow-up period | 72 months |
| Duration of hospitalizations due to cardiovascular causes during the follow-up period | 72 months |
| Total number of hospitalizations from any cause during the follow-up period | 72 months |
| Duration of hospitalizations from any cause during the follow-up period | 72 months |
| Quality of life assessed by the scoring obtained from EuroQol questionnaires (EQ-5D-5L) during the follow-up period | 72 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
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