Status:
COMPLETED
Inflammation, Cardiac Sympathetic Innervation, and Arrhythmic Sudden Death
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institutes of Health (NIH)
General Electric
Conditions:
Ischemic Cardiomyopathy
Dilated Cardiomyopathy
Eligibility:
All Genders
18+ years
Brief Summary
Despite pharmacologic advances for the treatment of congestive heart failure (HF), sudden cardiac death (SCD) and pump failure remain the leading causes of mortality in patients with HF. Although, SCD...
Detailed Description
The primary aim is as follows: Primary Aim 1: Determine if inflammation is associated with abnormal cardiac sympathetic innervation in patients enrolled in the PROSE-ICD study. Rationale/Hypothesis:...
Eligibility Criteria
Inclusion
- Patient Population - This proposal will enroll patients from the PROSE-ICD cohort who have undergone ICD implantation for primary prevention of SCD. PROSE-ICD is a multicenter prospective observational cohort study designed to identify risk factors for SCD in high-risk patients.
- Inclusion Criteria The entire PROSE-ICD population with ischemic and non-ischemic cardiomyopathy will be divided into quartiles based on previously measured hsCRP levels in the PROSE-ICD database. The study sample for this study will include 50 randomly selected PROSE-ICD participants from the lowest hsCRP quartile and another 50 randomly selected participants from the highest quartile. PROSE-ICD includes patients greater than 18 years old who have a history of acute MI at least 4 weeks old (confirmed by persistent pathologic Q waves on ECG, CPK-MB \> three times the upper limit of normal, or a fixed perfusion defect on nuclear imaging) or non-ischemic LV dysfunction for at least 9 months who have an EF ≤ 35% and who have undergone implantation of an FDA-approved ICD for primary prevention of SCD within 2 weeks of enrollment.
- Exclusion Criteria Exclusion criteria for PROSE-ICD include an indication for ICD implantation for secondary prevention; inability or unwillingness to provide informed consent; women \<50 years old with anatomic child-bearing potential who are unwilling to use contraceptives; NYHA class IV HF; patients with permanent pacemakers; and unsuccessful ICD implantation
- Additional exclusion criteria for PROSE-ICD patients enrolled in MIBG imaging will include:
- Positive pregnancy test in women with child bearing potential
- Use of a medication for non-cardiac conditions that may interfere with MIBG that cannot be safely withheld for five half-lives before study procedures.
- Renal insufficiency (GFR \<30 ml/dl or creatinine \>3.0 mg/dl) or dialysis.
- Hypersensitivity to iodine.
Exclusion
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01919983
Start Date
March 1 2012
End Date
September 1 2014
Last Update
December 8 2017
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287