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NCT02127307 · ClinicalTrials.gov registry record
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.
A clinical trial, sponsored by GE Healthcare.
- Completed
- Registry status
- 964
- Enrollment target
NCT02127307: Completed study, sponsored by GE Healthcare.
NCT02127307 is a clinical trial that has completed, run by GE Healthcare. The registered enrollment target is 964 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02127307 has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- 964 participants
- Enrollment target
Study Summary
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).
Primary Outcome
H/M ratio for 123I-mIBG uptake 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. H/M ratios were categorized as 'Low' and 'High' based on being \<1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data, as reflected by the H/M ratio, for identifying HF participants at lower risk of death during 60 months of fo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 964 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-04 |
What the finished NCT02127307 record still lists
NCT02127307 is an observational study that tracks outcomes without assigning an intervention. The registered 964 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02127307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02127307 about?
NCT02127307 is a clinical study titled "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.". 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 MBG3...
What is the current status of trial NCT02127307?
This trial is currently completed. The enrollment target is 964 participants. The study started on 2014-02. Estimated completion is 2016-04.
Who is sponsoring clinical trial NCT02127307?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
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