Observational study on heart defibrillators for preventing sudden cardiac death
Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)
This study looks at patients with heart defibrillators to see what factors might increase the risk of sudden cardiac death and how to better choose who needs these devices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 4 sites (Washington D.C., District of Columbia and 3 other locations) |
| Trial ID | NCT00733590 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the biological mechanisms that lead to sudden cardiac death (SCD) by examining patients with implanted internal defibrillators (ICDs) for primary prevention. It will categorize and follow these patients to identify clinical, electrocardiographic, genetic, and blood protein markers that indicate an increased risk of SCD. The study will compare patients who experience SCD events to those who do not, using standardized ICD settings to facilitate rhythm identification. The goal is to improve patient selection for ICD therapy based on their risk profiles.
Who should consider this trial
Good fit: Ideal candidates include patients with a history of acute myocardial infarction, non-ischemic left ventricular dysfunction, and an ejection fraction of 35% or less who are undergoing ICD generator replacement for primary prevention.
Not a fit: Patients with secondary prevention ICD replacements or those with advanced heart failure (NYHA Class IV) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification of patients who would benefit from ICD implantation, potentially reducing the incidence of sudden cardiac death.
How similar studies have performed: Other studies have shown success in identifying risk factors for sudden cardiac death, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of acute MI at least 4 weeks old * Non-ischemic LV dysfunction for at least 9 months * Who have an ejection fraction (EF) \< or = to 35% * Undergone elective replacement indicator (ERI) generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment. * Who have primary prevention implants. Exclusion Criteria: * ICD generator replacement for secondary prevention * Inability or unwillingness to provide valid informed consent * New York Heart Association Class IV heart failure * Patients with pre-existing Class 1 indications for pacemaker therapy.
Where this trial is running
Washington D.C., District of Columbia and 3 other locations
- Washington Hospital Center — Washington D.C., District of Columbia, United States (Recruiting)
- University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Recruiting)
- Virginia Commonwealth University School of Medicine — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Katherine C Wu, MD — Associate Professor of Medicine Johns Hopkins University
- Study coordinator: Katherine Wu, MD
- Email: kwu@jhmi.edu
- Phone: 410-502-7283
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.