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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
November 4, 2008
November 5, 2008
April 8, 2015
April 26, 2017
April 26, 2017
May 2008
January 2010   (Final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT00785044 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
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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
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.
Not Provided
Observational
Observational Model: Other
Time Perspective: Prospective
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Non-Probability Sample
Heart Failure Participants who participated in: MBG311 (NCT00126425) and MBG312/312C (NCT00126438).
Congestive Heart Failure
Drug: I-123 mIBG
This was an observational study. Participants were previously dosed in separate study.
Group
No participants received any drug administration. No intervention conducted.
Intervention: Drug: I-123 mIBG
Not Provided

*   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 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00785044
MBG313
No
Not Provided
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GE Healthcare
GE Healthcare
Not Provided
Study Director: John Strohmeyer GE Healthcare
GE Healthcare
April 2017