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

GE Healthcare471 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

471

Conditions

Congestive Heart Failure

Interventions

I-123 mIBGDRUG

This was an observational study. Participants were previously dosed in separate study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.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.

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

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

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.

Time frame: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months

Data from ClinicalTrials.gov

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