Predicting Ventricular Tachycardia Events Using Heart Imaging in Adults with Non-Ischemic Cardiomyopathy
An International Multicenter Observational Study
Led by Centro Medico Teknon · Updated on 2024-12-12
500
Participants Needed
4
Research Sites
16 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating how to better predict the risk of sudden cardiac death SCD and dangerous heart rhythms in patients with non-ischemic cardiomyopathy NICM, a heart condition affecting the left ventricle. Current methods based on low heart function do not adequately identify all patients at risk, as many with better heart function still suffer from sudden cardiac arrests. This study focuses on detailed heart tissue imaging using late gadolinium enhancement cardiac magnetic resonance, LGE-CMR to identify scar and border zone masses that might better predict these risks.
The study uses advanced image processing software ADAS 3D LV to analyze scar tissue characteristics such as border zone mass and heterogeneous tissue channels HTC in the heart. It includes a main retrospective cohort study, a prospective validation cohort, and a retrospective subgroup analysis assessing changes in scar features over time. Participants are patients diagnosed with NICM without previous arrhythmia events, who have had or will have LGE-CMR scans as part of their clinical care.
Participants will be followed for up to 100 months from their first CMR scan to see if they experience sudden cardiac death, sustained ventricular arrhythmias, or receive defibrillator therapy. Researchers will collect data on heart function, scar characteristics, patient age, and genetic information when available. No treatments are assigned by the study it observes outcomes based on existing clinical data and imaging. The study aims to improve risk classification for these patients over a period of at least two years or more.
CONDITIONS
Brief Title
Image-Based Prediction of Ventricular Tachycardia Events in Non-ischemic Cardiomyopathy
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Diagnosis of non-ischemic heart disease involving the left ventricle, including dilated cardiomyopathy, non-dilated left ventricular cardiomyopathy, or post-myocarditis cardiomyopathy
Life expectancy of more than 1 year with good functional status
Signed informed consent
At least one late gadolinium enhancement cardiac MRI (LGE-CMR) already performed
No ventricular arrhythmia events at the time of first LGE-CMR study
You will not qualify if you...
Pregnancy
Life expectancy less than 1 year or poor functional status (NYHA IV class)
Other structural heart diseases such as ischemic, congenital, or arrhythmogenic right ventricular cardiomyopathy
No LGE-CMR at enrollment or unavailable LGE-CMR data
Previously documented sustained ventricular arrhythmias at time of first LGE-CMR
Receiving other investigational treatments
Medical, geographical, or social factors preventing participation or inability to give informed consent
Patient refusal to participate in the study
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - At enrollment
Participants undergo cardiac MRI imaging to assess heart scar characteristics as part of standard clinical care.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 100 months
Participants are observed over time to monitor for sudden cardiac death, sustained ventricular arrhythmia, or defibrillator therapy.
Follow-up visits as per clinical practice
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Left ventricular midwall fibrosis as a predictor of mortality and morbidity after cardiac resynchronization therapy in patients with nonischemic cardiomyopathy.
Francisco Leyva, Robin J Taylor, Paul W X Foley...
Scar Characterization to Predict Life-Threatening Arrhythmic Events and Sudden Cardiac Death in Patients With Cardiac Resynchronization Therapy: The GAUDI-CRT Study.
Juan Acosta, Juan Fernández-Armenta, Roger Borràs...