Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease
Overview
The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcomes in subjects with heart failure and in comparison to subjects without cardiovascular disease.
Full Title of Study: “An Open-Label, Multicenter, Phase 3 Study Evaluating the Prognostic Usefulness of I-123 mIBG Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: July 2008
Interventions
- Drug: 123I-mIBG (meta-iodobenzylguanidine)
- Single dose
Arms, Groups and Cohorts
- Experimental: 123I-mIBG (meta-iodobenzylquanidine
- Single dose
Clinical Trial Outcome Measures
Primary Measures
- Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio
- Time Frame: Approximately 24 months from the date of administration of 123I-mIBG
- H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7×7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as ‘Low’ and ‘High’ based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events.
Participating in This Clinical Trial
Inclusion Criteria
- Study subjects must be adults with an established diagnosis of heart failure (New York Heart Association Class II or III) and reduced left ventricular ejection fraction (LVEF) (≤ 35%) or be healthy volunteers without heart disease. Exclusion Criteria:
- Healthy volunteers are not eligible if they have a history diabetes mellitus, signs/symptoms of neurological disease (eg, Parkinson's Disease, multiple system atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic nervous system. – Subjects with New York Heart Association Class I or IV heart failure are not eligible.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- GE Healthcare
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- John Lombard, Study Director, GE Healthcare
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