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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.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00126438
First received: August 3, 2005
Last updated: March 24, 2017
Last verified: March 2017
  Purpose
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.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome 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 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.


Enrollment: 515
Study Start Date: July 2005
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 123I-mIBG (meta-iodobenzylguanidine)
Single dose
Drug: 123I-mIBG (meta-iodobenzylguanidine)
Single Dose
Other Names:
  • MIBG
  • Iobenguane

  Eligibility

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126438

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00126438     History of Changes
Other Study ID Numbers: MBG312
Study First Received: August 3, 2005
Results First Received: June 30, 2015
Last Updated: March 24, 2017

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

ClinicalTrials.gov processed this record on August 18, 2017