Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/27/2017 |
| Start Date: | May 2008 |
| End Date: | February 2010 |
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.
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.
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- The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.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.
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