N/A
Completed N=964
Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event
Source: ClinicalTrials.gov NCT00785044 ↗Enrolled (actual)
964
Serious AEs
—
Results posted
Apr 2017
Primary outcomePrimary: 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 — 1.451; 1.394 Ratio — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1.451; 1.394 | <0.001 sig |
Eligibility 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- The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.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.
Data sourced from ClinicalTrials.gov (NCT00785044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.