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Principal Investigator Name: Gordon Tomaselli, MD, FAHA, FACC, FHRS
Study Coordinator: Barbara Butcher, R.N.
Contact Phone: (443) 287-3472
Contact email: firstname.lastname@example.org
Study Short Title: PROSE-ICD
Long Title: Fundamental Biology of Sudden Cardiac Death
and Its Application to Identify Patients at Risk
Funding source: NIH/NHLBI and Johns Hopkins Cardiovascular
Summary of Trial: This study examines the role of genetic, protein and
electrocardiographic markers measured
longitudinally in predicting the risk of SCD and
overall mortality in patients with implantable
defibrillators placed for primary prevention
- history of acute MI at least 4 weeks old
- non-ischemic LV dysfunction for at least 9 months
- EF < or = to 35%
- undergone implantation of an FDA-approved ICD for primary prevention of SCD within 4 weeks of enrollment
- ICD implantation for secondary prevention
- inability or unwillingness to provide valid informed consent
- women < 50 years old with anatomic child-bearing potential who are unwilling to use contraceptives
- New York Heart Association class IV heart failure
- patients with permanent pacemakers or pre-existing Class 1 indications for pacemaker implantation
- Unsuccessful ICD implantation
Clinical Trial Sites:
Johns Hopkins Hospital
Medical College of Virginia
Washington Hospital Center
Virginia College of Medicine
Compensation for Participating: No
Start Date: 2003
Anticipated Stop Date: December 31, 2011