CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)

Sponsor

Centro Medico Teknon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04599439

Collaborator

(none)

1,000

Enrollment

Location

37.9

Anticipated Duration (Months)

26.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (> 5% of the left ventricular -LV- mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from sustained monomorphic ventricular tachycardias (SMVT) than in matched controls for age, sex, infarct location, and left ventricular ejection fraction (LVEF). However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of sudden cardiac death (SCD). In a recent, case-control study, we identified the border zone channel (BZC) mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical SL, Barcelona, Spain), with FDA 510(k) Clearance and CE Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of approx. 2 years.

In the present cohort study, we sought to evaluate the usefulness of the BZC mass measurement to predict the occurrence of VT events in a prospective, multicenter, unselected series of consecutive chronic ischemic patients without previous arrhythmia evidence, irrespectively of their LVEF.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Myocardial Infarction Old Arrhythmias, Cardiac Ventricular Tachycardia Ventricular Arrythmia Sudden Cardiac Death Sudden Cardiac Death Due to Cardiac Arrhythmia	Diagnostic Test: Cardiac magnetic resonance imaging

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
High arrhythmia risk Patients with a cardiac magnetic resonance-derived border zone channel (BZC) mass > 5.15 g will be considered at highest risk for developing ventricular arrhythmias (VA) or sudden cardiac death (SCD).	Diagnostic Test: Cardiac magnetic resonance imaging All patients will undergo a cardiac magnetic resonance test to calculate their border zone channel (BZC) mass. This will not be used to decide further interventions, but all the patients will be treated according to standards of care.
Low arrhythmia risk Patients with a cardiac magnetic resonance-derived border zone channel (BZC) mass < 5.15 g will be considered at lowest risk for developing ventricular arrhythmias (VA) or sudden cardiac death (SCD).	Diagnostic Test: Cardiac magnetic resonance imaging All patients will undergo a cardiac magnetic resonance test to calculate their border zone channel (BZC) mass. This will not be used to decide further interventions, but all the patients will be treated according to standards of care.

Arm

Intervention/Treatment

High arrhythmia risk

Patients with a cardiac magnetic resonance-derived border zone channel (BZC) mass > 5.15 g will be considered at highest risk for developing ventricular arrhythmias (VA) or sudden cardiac death (SCD).

Diagnostic Test: Cardiac magnetic resonance imaging

All patients will undergo a cardiac magnetic resonance test to calculate their border zone channel (BZC) mass. This will not be used to decide further interventions, but all the patients will be treated according to standards of care.

Low arrhythmia risk

Patients with a cardiac magnetic resonance-derived border zone channel (BZC) mass < 5.15 g will be considered at lowest risk for developing ventricular arrhythmias (VA) or sudden cardiac death (SCD).

Diagnostic Test: Cardiac magnetic resonance imaging

Outcome Measures

Primary Outcome Measures

Ventricular arrhythmias or sudden cardiac death [2 years]
Clinical composite of cardiac death or any sustained ventricular arrhythmia after a 2-year follow-up period.

Secondary Outcome Measures

Non-cardiac causes of mortality [2 years]
Death due to non-cardiac conditions
Heart failure hospitalization rate [2 years]
Hospitalization due to decompensated heart failure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18 years.
Chronic (> 3 months after the index coronary event), stable ischemic heart disease, irrespectively of the LVEF.
Life expectancy of > 1 year with a good functional status.
Signed informed consent.

Exclusion Criteria:

Age < 18 years.
Pregnancy.
Life expectancy of < 1 year, or bad functional status (NYHA IV functional class).
Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
Previously documented sustained ventricular arrhythmias.
Impossibility or contraindications to undergo a contrast-enhanced CMR study.
Concomitant investigation treatments.
Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.