Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event
|ClinicalTrials.gov Identifier: NCT00785044|
Recruitment Status : Completed
First Posted : November 5, 2008
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
|Condition or disease||Intervention/treatment|
|Congestive Heart Failure||Drug: I-123 mIBG|
|Study Type :||Observational|
|Actual Enrollment :||471 participants|
|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|
|Study Start Date :||May 2008|
|Primary Completion Date :||January 2010|
|Study Completion Date :||February 2010|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785044
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||John Strohmeyer||GE Healthcare|