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Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease

This study has been completed.
Information provided by (Responsible Party):
GE Healthcare Identifier:
First received: August 3, 2005
Last updated: March 24, 2017
Last verified: March 2017

August 3, 2005
March 24, 2017
July 2005
July 2008   (Final data collection date for primary outcome measure)
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 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. Data analysis to assess the relative hazard of an adverse cardiac event was performed only on HF participants categorized into 2 groups with H/M <1.6 and H/M ≥1.6 using a Cox proportional hazards model.
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Complete list of historical versions of study NCT00126438 on Archive Site
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Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease
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.
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Phase 3
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Heart Failure, Congestive
Drug: 123I-mIBG (meta-iodobenzylguanidine)
Single Dose
Other Names:
  • MIBG
  • Iobenguane
Experimental: 123I-mIBG (meta-iodobenzylguanidine)
Single dose
Intervention: Drug: 123I-mIBG (meta-iodobenzylguanidine)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2008
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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GE Healthcare
GE Healthcare
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Study Director: John Strohmeyer GE Healthcare
GE Healthcare
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP