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

NCT04599439 | Unknown

• 1 other identifier: DEVELOP-VT
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Ventricular arrhythmias or sudden cardiac death

  Clinical composite of cardiac death or any sustained ventricular arrhythmia after a 2-year follow-up period.

  2 years

Secondary Outcomes (2)

• Non-cardiac causes of mortality

  2 years

• Heart failure hospitalization rate

  2 years

Study Arms (2)

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

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

Interventions

Cardiac magnetic resonance imaging DIAGNOSTIC_TEST

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.

High arrhythmia risk; Low arrhythmia risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Medico Teknon: lead

Study Sites (1)

Antonio Berruezo, MD, PhD

Barcelona, 08022, Spain

RECRUITING

Related Publications (14)

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  PMID: 21880674 BACKGROUND

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MeSH Terms

Conditions

Myocardial Infarction; Arrhythmias, Cardiac; Tachycardia, Ventricular; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Tachycardia; Cardiac Conduction System Disease; Heart Arrest; Death, Sudden; Death

Study Officials

• Antonio Berruezo, MD, PhD

  Centro Médico Teknon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Berruezo, MD, PhD

CONTACT

(+34) 93 290 62 51; antonio.berruezo@quironsalud.es

Beatriz Jáuregui, MD

CONTACT

(+34) 93 290 62 51; beatriz.jauregui@quironsalud.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Arrhythmia Department & Director of Research and Innovation

Study Record Dates

• First Submitted: October 17, 2020
• First Posted: October 22, 2020
• Study Start: August 1, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)