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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00785044
First Posted: November 5, 2008
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GE Healthcare
  Purpose
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
Group
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.

  Eligibility

Information from the National Library of Medicine

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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).
Criteria

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
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): NCT00785044


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

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00785044     History of Changes
Other Study ID Numbers: MBG313
First Submitted: November 4, 2008
First Posted: November 5, 2008
Results First Submitted: April 8, 2015
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by GE Healthcare:
Heart Failure
MIBG
123I-mIBG

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