GE Healthcare
Princeton, New Jersey, 08540, United States
NCT Number: NCT02127307
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).
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Notify Me18 year and older
All sexes
Observational
Princeton, New Jersey, 08540, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months
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 follow-up.
GE Healthcare
Industry
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.
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