Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | July 2005 |
| End Date: | September 2008 |
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
The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to
predict cardiac outcome in subjects with heart failure and in comparison to subjects without
cardiovascular disease.
predict cardiac outcome in subjects with heart failure and in comparison to subjects without
cardiovascular disease.
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 were not eligible if they had a history of diabetes mellitus,
signs/symptoms of neurological disease (e.g., 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 were not
eligible.
- Subjects were excluded if they had previously received 123I-mIBG or 131I-mIBG or
participated in a clinical study involving investigational medicinal product or
devices within 30 days.
- Subjects that had a pacemaker or had received defibrillation, anti-tachycardia pacing
or cardioversion to treat a previous arrhythmic event or had an ICD inserted within 30
days before study entry are not eligible.
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