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

August 29, 2023 updated by: Antonio Berruezo, MD, PhD, Centro Medico Teknon

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.

Study Overview

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Barcelona, Spain, 08022
        • Recruiting
        • Antonio Berruezo, MD, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonio Berruezo, MD, PhD
        • Sub-Investigator:
          • Beatriz Jáuregui, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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).
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventricular arrhythmias or sudden cardiac death
Time Frame: 2 years
Clinical composite of cardiac death or any sustained ventricular arrhythmia after a 2-year follow-up period.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-cardiac causes of mortality
Time Frame: 2 years
Death due to non-cardiac conditions
2 years
Heart failure hospitalization rate
Time Frame: 2 years
Hospitalization due to decompensated heart failure
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Antonio Berruezo, MD, PhD, Centro Medico Teknon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

October 17, 2020

First Submitted That Met QC Criteria

October 18, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Cardiac magnetic resonance imaging

3
Subscribe