Clinical trial NCT04599439: CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)
Official title: CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Myocardial Infarction Old
Arrhythmias, Cardiac
Ventricular Tachycardia
Ventricular Arrythmia
Sudden Cardiac Death
Sudden Cardiac Death Due to Cardiac Arrhythmia
Keywords: myocardial infarction
cardiac magnetic resonance imaging
scar arrhythmogenicity
ventricular arrhythmias
sudden cardiac death
border zone channels
Lead sponsor: Centro Medico Teknon
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with chronic (\> 3 months after the index coronary event), stable ischemic heart disease, irrespectively of the LVEF, will be included.

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, Barcelona, Spain), with FDA 510(k) Clearance and European Community 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ventricular arrhythmias or sudden cardiac death
timeFrame: 2 years
Secondary outcomes:
measure: Non-cardiac causes of mortality
timeFrame: 2 years
measure: Heart failure hospitalization rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Antonio Berruezo, MD, PhD
Study officials:
affiliation: Centro Médico Teknon
name: Antonio Berruezo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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