CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry (DERIVATE)
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/22/2018 |
| Start Date: | January 2010 |
| End Date: | December 2020 |
CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry
The DERIVATE study was conceived to integrate the information resulted from clinical data,
transthoracic echocardiography, and cardiac magnetic resonance (CMR) imaging to provide a
more reliable risk stratification in patients affected by heart failure (HF) and worthy of
prophylactic implanted cardioverter defibrillator (ICD) therapy. The main purposes of this
multicenter registry are to: 1) determine CMR findings, and specifically late gadolinium
enhancement (LGE) features, T1 mapping, and extracellular volume (ECV) that predict sudden
cardiac death (SCD) and ventricular arrhythmia; 2) provide a comprehensive clinical and
imaging score that effectively improves the selection of patients who deserve a prophylactic
ICD therapy; 3) evaluate the contribution of machine learning to predict major adverse
cardiac events (MACE) as compared to standard clinical scores.
transthoracic echocardiography, and cardiac magnetic resonance (CMR) imaging to provide a
more reliable risk stratification in patients affected by heart failure (HF) and worthy of
prophylactic implanted cardioverter defibrillator (ICD) therapy. The main purposes of this
multicenter registry are to: 1) determine CMR findings, and specifically late gadolinium
enhancement (LGE) features, T1 mapping, and extracellular volume (ECV) that predict sudden
cardiac death (SCD) and ventricular arrhythmia; 2) provide a comprehensive clinical and
imaging score that effectively improves the selection of patients who deserve a prophylactic
ICD therapy; 3) evaluate the contribution of machine learning to predict major adverse
cardiac events (MACE) as compared to standard clinical scores.
The current guidelines provide indications for primary prevention implanted cardioverter
defibrillator (ICD) therapy based on left ventricle ejection fraction (LVEF) and New York
Heart Association (NYHA) class. This strategy is able to intercept only part of fatal
arrhythmic events and, on the other hand, led to useless ICD implantations mainly among those
patients with severe heart failure (HF) who will never incur in sever arrhythmias but rather
will die because of decompensated HF. Cardiac magnetic resonance offers the possibility of
identifying and quantitatively assessing myocardium fibrosis both localized in a specific
area and diffuse and has already proved a significant prognostic meaning. DERIVATE is a
prospective, international, multicenter, observational registry of stable HF patients with
reduced LVEF who underwent clinical evaluation, transthoracic echocardiography (TTE) and
cardiac magnetic resonance (CMR). Specifically, the primary aim of DERIVATE is to determine
CMR findings that predict outcomes, with incremental value over LVEF and NYHA classification.
The DERIVATE registry uses a collaborative design with contribution and merger of similar
prospectively enrolled cohorts from 33 sites in 6 countries in Europe and North America. The
targeted population for the DERIVATE registry is a large sample of patients with clinical
history of chronic HF who have undergone CMR by referral physician. Indication for CMR exams
was recorded and classified according to the known causes of HF. All DERIVATE study patients
are followed for all-cause mortality, sudden cardiac death (SCD), cardiovascular death
(including death caused by acute myocardial infarction and stroke), sustained ventricular
tachycardia (VT), aborted SCD, hospitalization or cardiac death related to chronic HF. The
follow up minimum period is 12 months. Complete risk factors, clinical presentation,
echocardiography and CMR data recording, and follow-up for all-outcomes will contribute data
for common analysis.
defibrillator (ICD) therapy based on left ventricle ejection fraction (LVEF) and New York
Heart Association (NYHA) class. This strategy is able to intercept only part of fatal
arrhythmic events and, on the other hand, led to useless ICD implantations mainly among those
patients with severe heart failure (HF) who will never incur in sever arrhythmias but rather
will die because of decompensated HF. Cardiac magnetic resonance offers the possibility of
identifying and quantitatively assessing myocardium fibrosis both localized in a specific
area and diffuse and has already proved a significant prognostic meaning. DERIVATE is a
prospective, international, multicenter, observational registry of stable HF patients with
reduced LVEF who underwent clinical evaluation, transthoracic echocardiography (TTE) and
cardiac magnetic resonance (CMR). Specifically, the primary aim of DERIVATE is to determine
CMR findings that predict outcomes, with incremental value over LVEF and NYHA classification.
The DERIVATE registry uses a collaborative design with contribution and merger of similar
prospectively enrolled cohorts from 33 sites in 6 countries in Europe and North America. The
targeted population for the DERIVATE registry is a large sample of patients with clinical
history of chronic HF who have undergone CMR by referral physician. Indication for CMR exams
was recorded and classified according to the known causes of HF. All DERIVATE study patients
are followed for all-cause mortality, sudden cardiac death (SCD), cardiovascular death
(including death caused by acute myocardial infarction and stroke), sustained ventricular
tachycardia (VT), aborted SCD, hospitalization or cardiac death related to chronic HF. The
follow up minimum period is 12 months. Complete risk factors, clinical presentation,
echocardiography and CMR data recording, and follow-up for all-outcomes will contribute data
for common analysis.
Inclusion Criteria:
- Heart Failure patients (according to the ACC/AHA classification) with known ischemic
cardiomyopathy (ICM) or non ischemic dilated cardiomyopathy (DCM)
- reduced left ventricle ejection fraction (LVEF) (<55%)
Exclusion Criteria:
- pregnancy
- current alcohol or drug abuse
- unstable angina
- decompensated HF (NYHA class IV) in the previous 1 month
- acute myocarditis in the previous 3 months
- recent myocardial infarction (MI) (<40 days) or)
- severe valvular disease
- cardiac amyloidosis
- hypertrophic cardiomyopathy
- arrhthmogenic right ventricular cardiomyopathy
- takotsubo cardiomyopathy
- congenital heart disease
- non CMR compatible device
- estimated glomerular filtration rate ≤30 mL/min/1.73m2
- other contraindication to gadolinium contrast agent
- severe claustrophobia
- participating in other trials with an active treatment arm (not to exclude patients
who are in trials of diagnostic techniques or approved therapies)
- unwilling or unable to provide informed consent.
We found this trial at
3
sites
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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