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Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event

This study has been completed.
Information provided by (Responsible Party):
GE Healthcare Identifier:
First received: November 4, 2008
Last updated: April 25, 2017
Last verified: April 2017
The study was designed to study the utility of meta-iodobenzylguanidine (123I-mIBG) imaging to identify those participants with heart failure who would experience an adverse cardiac event during 24 months of follow-up from the administration date of 123I-mIBG in previous studies MBG311 or MBG312.

Condition Intervention
Congestive Heart Failure Drug: I-123 mIBG

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: An Open-label, Multicentre, Phase 3 Study to Demonstrate the Prognostic Usefulness of 123I-mIBG Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event During 24 Months Followup

Resource links provided by NLM:

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status [ Time Frame: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months ]
    The numerical value of 123 I-mIBG uptake (H/M ratio) 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. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis.

Enrollment: 471
Study Start Date: May 2008
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No participants received any drug administration. No intervention conducted.
Drug: I-123 mIBG
This was an observational study. Participants were previously dosed in separate study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart Failure Participants who participated in: MBG311 (NCT00126425) and MBG312/312C (NCT00126438).

Inclusion Criteria:

  • The subject was a Heart Failure subject who signed informed consent for MBG311, MBG312, or MBG312C.
  • The subject was administered 123I-mIBG in MBG311, MBG312, or MBG312C.
  • The subject completed the late planar imaging assessments (at a minimum) required by the protocols for MBG311, MBG312, or MBG312C.
  • The subject agreed to allow the investigator access to medical records, including those relating to subject death should this occur.

Exclusion Criteria:

  • The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.
  • The subject was considered lost-to-follow-up (6 months without contact) in MBG311, MBG312, or MBG312C.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00785044

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

Responsible Party: GE Healthcare Identifier: NCT00785044     History of Changes
Other Study ID Numbers: MBG313
Study First Received: November 4, 2008
Results First Received: April 8, 2015
Last Updated: April 25, 2017

Keywords provided by GE Healthcare:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals processed this record on September 21, 2017