Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease

GE Healthcare587 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

587

Conditions

Heart Failure, Congestive

Interventions

123I-mIBG (meta-iodobenzylguanidine)DRUG

Single dose

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

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

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 7x7 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.

Time frame: Approximately 24 months from the date of administration of 123I-mIBG

Data from ClinicalTrials.gov

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