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

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ClinicalTrials.gov Identifier: NCT00126425
Recruitment Status : Completed
First Posted : August 4, 2005
Results First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: 123I-mIBG (meta-iodobenzylguanidine) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 587 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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 Start Date : July 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 123I-mIBG (meta-iodobenzylquanidine
Single dose
Drug: 123I-mIBG (meta-iodobenzylguanidine)
Single dose
Other Names:
  • Iobenguane
  • mIBG
  • meta-iodobenzylguanidine



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126425


Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: John Lombard GE Healthcare

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00126425     History of Changes
Other Study ID Numbers: MBG311
First Posted: August 4, 2005    Key Record Dates
Results First Posted: December 13, 2016
Last Update Posted: December 13, 2016
Last Verified: October 2016

Keywords provided by GE Healthcare:
Heart Failure
nuclear cardiology
sympathetic innervation
123I-mIBG

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
3-Iodobenzylguanidine
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals