Predicting Ventricular Tachycardia Events in Patients with Healed Heart Attacks
CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)
This study is trying to see if special heart scans can help predict dangerous heart rhythms in people who have had previous heart attacks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Medico Teknon Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04599439 on ClinicalTrials.gov |
What this trial studies
This observational study aims to utilize cardiac magnetic resonance imaging (CMR) to predict the occurrence of ventricular tachycardia events in patients who have experienced healed myocardial infarctions. By assessing the fibrotic tissue in the heart, the study seeks to identify arrhythmogenic substrates that could lead to serious cardiac events. The research focuses on patients with chronic ischemic heart disease and evaluates the relationship between scar tissue and the risk of arrhythmias. The findings could help in determining the need for implantable cardioverter-defibrillator (ICD) placement in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with chronic stable ischemic heart disease and a life expectancy of more than one year.
Not a fit: Patients with a life expectancy of less than one year, those with other structural heart diseases, or those who have previously documented sustained ventricular arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict life-threatening arrhythmias in patients with a history of myocardial infarction, potentially improving patient outcomes.
How similar studies have performed: Previous studies have indicated that cardiac magnetic resonance imaging can effectively identify arrhythmogenic substrates, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona
- Antonio Berruezo, MD, PhD — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio Berruezo, MD, PhD — Centro Médico Teknon
- Study coordinator: Antonio Berruezo, MD, PhD
- Email: antonio.berruezo@quironsalud.es
- Phone: (+34) 93 290 62 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.