Phase 4 Study to Demonstrate Prognostic Usefulness of AdreView™ Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience Death During 60 Months Follow-up.
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/12/2016 |
| Start Date: | February 2014 |
| End Date: | April 2016 |
An Open-Label, Multicenter, Phase 4 Study to Demonstrate the Prognostic Usefulness of AdreView™ Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience Death During 60 Months Follow-up.
This aim of the study is to investigate the prognostic usefulness of AdreView™ imaging to
identify those subjects with New York Heart Association (NYHA) Class II or III HF who will
die during 60 months of follow-up from the date of administration of AdreView™ in prior
studies MBG311, MBG312, or MBG312C (hereafter included in MBG312).
identify those subjects with New York Heart Association (NYHA) Class II or III HF who will
die during 60 months of follow-up from the date of administration of AdreView™ in prior
studies MBG311, MBG312, or MBG312C (hereafter included in MBG312).
Inclusion Criteria:
- The subject was a HF subject who had signed informed consent for MBG311 or MBG312.
- The subject was administered AdreView™ in MBG311 or MBG312.
- The subject completed the late planar imaging assessments (at a minimum) required by
the protocols for MBG311 and MBG312, and those images were read and judged diagnostic
by at least 2 blinded readers.
- In addition, all subjects must meet 1 of the following 3 inclusion criteria.
- If the subject can be located, he/she provides informed consent to allow the
investigator access to medical records and/or gives permission for the investigator
to speak to treating physicians.
- If the subject can be located and he/she declines to provide informed consent, the
IRB/EC provides a waiver of consent to allow the investigator to record that the
subject is alive.
- If the subject cannot be located, the IRB/EC provides a waiver of consent to allow
the investigator to access available medical records for care provided subsequent to
last date of subject participation in MBG311, MBG312, and/or MBG313 and/or to allow
collection of data from publicly available sources.
Exclusion Criteria:
- The subject withdrew or was withdrawn from MBG311 or MBG312 because of a protocol
violation.
- The subject underwent heart transplantation during MBG311, MBG312, or MBG313.
- The subject was recorded to have died during MBG311, MBG312, or MBG313.
- The subject voluntarily withdrew from MBG311, MBG312, or MBG313, and the IRB/EC has
not provided a waiver to allow recording of subject survival status in such an
instance.
- The subject cannot be located, cannot be contacted, and no information can be found
to establish survival status beyond the date of last contact in MBG311, MBG312, or
MBG313, including information available as a result of an IRB/EC-approved waiver.
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