Myocardial InfarctionSMART-DEFNCT06269692
MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
A study testing MRI screening, Implantable Loop Recorder and Implantable Cardioverter Defibrillator in people with Myocardial Infarction and Ventricular Tachycardia, run by Central Hospital, Nancy, France at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Ventricular Tachycardia, Ventricular Fibrillation
- What is being tested?
- MRI screening, Implantable Loop Recorder and Implantable Cardioverter Defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,812 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to 1 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christian de CHILLOU, MD, PhD contact
Guilaume DROUOT, PhD contact
France1 site
CHRU Nancy
Vandœuvre-lès-Nancy, 54511
Christian de CHILLOU, MD, PhD, c.dechillou@chru-nancy.fr
Guillaume DROUOT, PhD, g.drouot@chru-nancy.fr
About this study
Official title: Multicenter randomiSed Trial on MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
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.
- Conditions
- Myocardial Infarction, Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death
- Being tested
- MRI screening, Implantable Loop Recorder, Implantable Cardioverter Defibrillator
- Keywords
- Myocardial Infarction
- Medical subject headings
- Myocardial Infarction, Tachycardia, Ventricular, Ventricular Fibrillation, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI screeningDevice
Cardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar
Implantable Loop RecorderDevice
Inplantation of the Implantable Loop Recorder (ILR) for the patients assigned to the experimental group
Implantable Cardioverter DefibrillatorDevice
Inplantation of the Implantable Cardioverter Defibrillator (ICD) for the patients assigned to the control group, according to the current guidelines
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MRI screening; Device: Implantable Loop Recorder |
| 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). Receives: Device: MRI screening; Device: Implantable Cardioverter Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 months
Secondary outcomes (15)
Total number of deaths during the follow-up period
Measured: 72 months
Total number of deaths from cardiovascular cause during the follow-up period
Measured: 72 months
Total number of SCD due to ventricular arrhythmia during the follow-up period
Measured: 72 months
Total number (per patient) of sustained VT episodes treated by the ICD or recorded by the ILR during the follow-up period
Measured: 72 months
Total number (per patient) of VF episodes treated by the ICD or recorded by the ILR during the follow-up period
Measured: 72 months
Total number of hospitalizations due to cardiovascular causes during the follow-up period
Measured: 72 months
Duration of hospitalizations due to cardiovascular causes during the follow-up period
Measured: 72 months
Total number of hospitalizations from any cause during the follow-up period
Measured: 72 months
Duration of hospitalizations from any cause during the follow-up period
Measured: 72 months
Quality of life assessed by the scoring obtained from EuroQol questionnaires (EQ-5D-5L) during the follow-up period
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,812 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian DE CHILLOU, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269692
- Sponsor's protocol ID
- 2023-A01353-42
- Acronym
- SMART-DEF
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter randomiSed Trial on MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
- ClinicalTrials.gov ID
- NCT06269692
- Acronym / sponsor ID
- SMART-DEF / 2023-A01353-42
- Conditions
- Myocardial Infarction, Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death
- Keywords
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,812 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implantable Loop Recorder | Experimental | Device: MRI screening, Device: Implantable Loop RecorderPatients 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 | Device: MRI screening, Device: Implantable Cardioverter DefibrillatorPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI screeningCardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar | Device | Implantable Cardioverter Defibrillator, Implantable Loop Recorder |
| Implantable Loop RecorderInplantation of the Implantable Loop Recorder (ILR) for the patients assigned to the experimental group | Device | Implantable Loop Recorder |
| Implantable Cardioverter DefibrillatorInplantation of the Implantable Cardioverter Defibrillator (ICD) for the patients assigned to the control group, according to the current guidelines | Device | Implantable Cardioverter Defibrillator |
Primary outcome
Occurrence of Sudden Cardiac Death (SCD) during the follow-up period
Time frame: 72 months
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.
15 secondary outcomes
Total number of deaths during the follow-up period
Time frame: 72 months
Total number of deaths from cardiovascular cause during the follow-up period
Time frame: 72 months
Total number of SCD due to ventricular arrhythmia during the follow-up period
Time frame: 72 months
Total number (per patient) of sustained VT episodes treated by the ICD or recorded by the ILR during the follow-up period
Time frame: 72 months
Total number (per patient) of VF episodes treated by the ICD or recorded by the ILR during the follow-up period
Time frame: 72 months
Total number of hospitalizations due to cardiovascular causes during the follow-up period
Time frame: 72 months
Duration of hospitalizations due to cardiovascular causes during the follow-up period
Time frame: 72 months
Total number of hospitalizations from any cause during the follow-up period
Time frame: 72 months
Duration of hospitalizations from any cause during the follow-up period
Time frame: 72 months
Quality of life assessed by the scoring obtained from EuroQol questionnaires (EQ-5D-5L) during the follow-up period
Time frame: 72 months
Measurements of the estimated costs
Time frame: 72 months
Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences
Time frame: 36 months
Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences
Time frame: 36 months
Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar
Time frame: 36 months
Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian de CHILLOU, MD, PhD contact
Guilaume DROUOT, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI screening, Implantable Loop Recorder and Implantable Cardioverter Defibrillator in people with Myocardial Infarction and Ventricular Tachycardia, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian de CHILLOU, MD, PhD (c.dechillou@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Sudden Cardiac Death (SCD) during the follow-up period (time frame: 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.