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NCT00126438 · ClinicalTrials.gov registry record · Phase 3
Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease
A Phase 3 study, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 515
- Enrollment target
NCT00126438: Completed Phase 3 study, sponsored by GE Healthcare.
NCT00126438 is a Phase 3 study that has completed, run by GE Healthcare. The registered enrollment target is 515 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00126438, a Phase 3 study, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 515 participants
- Enrollment target
Study Summary
The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcome in subjects with heart failure and in comparison to subjects without cardiovascular disease.
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. Assessments were done by 3 independent readers. 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 collected relative to time to adverse cardiac events. Data an
Interventions
- DRUG 123I-mIBG (meta-iodobenzylguanidine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2005-07 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
What the finished NCT00126438 record still lists
NCT00126438 is an interventional study that assigns participants to a tested intervention. The registered 515 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which 123I-mIBG (meta-iodobenzylguanidine) is the first listed.
NCT00126438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00126438 about?
NCT00126438 is a clinical study titled "Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease". The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcome in subjects with heart failure and in comparison to subjects without cardiovascular disease.
What is the current status of trial NCT00126438?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 515 participants. The study started on 2005-07. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00126438?
The interventions under investigation include: 123I-mIBG (meta-iodobenzylguanidine) (DRUG).
Who is sponsoring clinical trial NCT00126438?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00126438's enrollment target sits among peer trials
515 724th of 2000 higher than 1,277 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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