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

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00785044
First received: November 4, 2008
Last updated: April 28, 2010
Last verified: April 2010

November 4, 2008
April 28, 2010
June 2008
January 2010   (final data collection date for primary outcome measure)
Demonstrate the prognostic usefulness of assessment of myocardial sympathetic innervation, measured by the numerical H/M ratio on planar 123I-mIBG imaging, for identifying heart failure subjects at higher risk of experiencing an adverse cardiac [ Time Frame: 24 months after dosing date in MBG 311/312/312C ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00785044 on ClinicalTrials.gov Archive Site
To identify the optimum H/M threshold that provides the best combination of Sensitivity and Specificity for identifying HF subjects at higher risk of experiencing an ACE during 24 months of follow-up. To demonstrate the prognostic usefulness of the heart [ Time Frame: 24 months after dosing date in MBG 311/312/312C ] [ Designated as safety issue: No ]
Same as current
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Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event
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

In the past two years, subjects participated in a medical research study using the investigational drug called 123I-Iodine meta-iodobenzylguanidine (123I-mIBG)(pronounced "123 I oo dine-meta ioo doo ben zul gwan nid deen"). The sponsor of that study (GE Healthcare) is now interested in gathering data concerning heart failure subjects and cardiac events, since they were enrolled in the original study. There will be no injections of radioactive imaging agents or repeat imaging studies.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

Heart Failure Subjects who participated in MBG 311/312/312C.

Heart Failure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
471
February 2010
January 2010   (final data collection date for primary outcome measure)

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 agrees 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00785044
MBG313
No
Arnold Jacobson, M.D., GE Healthcare
GE Healthcare
Not Provided
Study Director: John Strohmeyer GE Healthcare
GE Healthcare
April 2010

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