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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