Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)
Johns Hopkins University
Summary
The overall hypothesis of this study is that subtle interactions between structural (substrate) and functional (trigger) abnormalities of the heart, some of which are genetically-determined, can be used to identify patients at high risk of sudden cardiac death (SCD). Such information may be used to better define patients most likely to benefit from replacement of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD pulse generator replacement for primary prevention of SCD (PROSe-ICD) was established to : 1. to gain a better understanding of the biological mechanisms that predispose to SCD 2. to develop readily determined clinical, electrocardiographic, genetic and blood protein markers identify patients with an increased risk of dying suddenly
Description
PROSe-ICD is a multicenter prospective cohort study of patients who undergo ICD implantation for primary prevention of SCD, designed to compare patients who sustain SCD (as measured by an appropriate ICD firing for rapid ventricular tachycardia (VT) or rapid ventricular fibrillation (VF) to those who do not. The cohort for this observational study consists of patients with cardiomyopathy who have an ICD implanted for primary SCD prevention according to recent trials (MADIT II, SCD-HeFT, DEFINITE) and practice guidelines. Patients are followed longitudinally for clinical, ECG, genomic and prot…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
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 indicatio…
Locations (4)
- Washington Hospital CenterWashington D.C., District of Columbia
- University of Maryland Medical CenterBaltimore, Maryland
- Johns Hopkins University School of MedicineBaltimore, Maryland
- Virginia Commonwealth University School of MedicineRichmond, Virginia