Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Sep 8, 2020

Keywords

ClinConnect Summary

This study, called BREACH-ECGI, is a research project aimed at better understanding how the heart’s electrical system works in people who have, or are at risk for, dangerous heart rhythms like ventricular tachycardia or sudden cardiac arrest. Researchers will compare two groups (a control group and a diseased group) using a noninvasive method called ECG-Imaging (ECGI). All participants will have a body surface mapping test with a vest of 256 chest electrodes plus a CT scan (or a CT/CMR scan) to map the heart’s structure. The goal is to learn more about where and how these electrical signals develop, which could improve how doctors predict risk and plan future treatments.

Who can participate? Adults 18 and older who either have a history of ventricular arrhythmias or are at risk for them, and have certain heart conditions (such as ischemic or non-ischemic cardiomyopathy, other heart diseases, some congenital heart conditions), or who have a structurally normal heart but need a heart CT for clinical reasons. Exclusions include known severe allergies to electrodes or contrast, serious other illnesses, pregnancy, kidney problems with very low filtration, or inability to consent. The study is being run in the Netherlands (Maastricht and Hasselt/Jessa hospitals) and is not a simple treatment trial—the information gathered may help scientists understand arrhythmias better and improve risk assessment in the future. The study is ongoing, with about 270 participants planned and results not yet available.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• In order to be eligible to participate in this study, a subject must be ≥ 18 years old, have either a history of VTAs or be at risk of VTAs and have one of the following diagnoses:
• • Ischemic cardiomyopathy
• • Non-ischemic cardiomyopathy
• • Non-structural heart disease
• • Congenital heart disease (with a limitation to CCTGA and situs inversus)
• • Or: a subject must be ≥ 18 years old and have a structurally normal heart with a clinical indication for a cardiac CT.
• Exclusion Criteria:
• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• • A known strong reaction against electrode attachment or contrast agent.
• • Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
• • Pregnancy, nursing or planning to be pregnant.
• • The subject has an estimated glomerular filtration rate (eGFR) of \<30mL/min/1.73m2, using the MDRD calculation 14.
• • Being unable to give informed consent.