Personalized risk prediction for sudden cardiac death
Use of interpREtable Artificial Intelligence techniqueS for a PErsonalized Risk prediCTion of Sudden Cardiac Death in Patients With Ischemic and Non-ischemic Left Ventricular Dysfunction (the RESPECT Study)
Istituto Auxologico Italiano · NCT06321900
This study is trying to create a personalized way to predict the risk of sudden cardiac death in people with heart problems by using advanced tests and information.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1050 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT06321900 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a personalized risk model for predicting sudden cardiac death (SCD) in patients with various cardiovascular diseases. It utilizes a combination of electrocardiography, advanced imaging biomarkers, and genetic testing to identify individuals at high risk for SCD, beyond the traditional reliance on left ventricular ejection fraction (LVEF). By integrating multiple risk factors, the study seeks to enhance the accuracy of risk stratification and improve patient outcomes. The research is led by Prof. Badano at the Istituto Auxologico Italiano in Milan.
Who should consider this trial
Good fit: Ideal candidates include patients with a history of ischemic cardiomyopathy and LVEF less than 50%, as well as those with specific types of cardiomyopathies at risk of SCD.
Not a fit: Patients with NYHA class IV heart failure or those who have experienced unexplained syncope or aborted SCD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the identification of patients at risk for sudden cardiac death, leading to better-targeted preventive measures.
How similar studies have performed: While there have been studies on individual biomarkers for predicting SCD, this approach of combining multiple risk factors is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * history of ischemic cardiomyopathy, LVEF \<50% by 2D echo, and NYHA class II or III; * primitive (dilated, hypertrophic, and arrhythmogenic) cardiomyopathies at risk of SCD; * signed informed consent to be part of the study. Exclusion Criteria: * unwilling to be part of the study, * NYHA class IV, * history of unexplained syncope, aborted SCD or documented sustained ventricular tachycardia, * insufficient acoustic window to allow the quantitation of LVEF by 2D echocardiography without the infusion of contrast agents (i.e., more than 2 LV segments not adequately visualized), * atrial fibrillation during the echocardiographic or CMR studies, * myocardial infarction in the 40 days or revascularization in the 90 days preceding the enrolment, * more than moderate stenosis or regurgitation of any heart valve.
Where this trial is running
Milan
- Istituto Auxologico Italiano IRCCS — Milan, Italy (RECRUITING)
Study contacts
- Principal investigator: Luigi Badano, MD, Ph.D. — Istituto Auxologico Italiano, IRCCS
- Study coordinator: Luigi Badano, MD, Ph.D.
- Email: l.badano@auxologico.it
- Phone: +3902619112319
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.
Conditions: Sudden Cardiac Death Due to Cardiac Arrhythmia, Cardiomyopathies, Ischemic Heart Disease, Cardiovascular Diseases, Personalized medicine, Sudden cardiac death, Artificial intelligence, Genetics