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Principal Investigator Name: Gordon Tomaselli, MD, FAHA, FACC, FHRS

Study Coordinator: Barbara Butcher, R.N.

Contact Phone: (443) 287-3472
Study Coordinator

Contact email:

Study Short Title: PROSE-ICD

Long Title: Fundamental Biology of Sudden Cardiac Death
and Its Application to Identify Patients at Risk

IRB#: NA_00045142 #: NCT00733590

Funding source: NIH/NHLBI and Johns Hopkins Cardiovascular
Clinical Center

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

Inclusion Criteria:

  • 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 6 months of enrollment

Exclusion Critria:

  • 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