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NCT01779869 · ClinicalTrials.gov registry record · Phase 4
Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson
A Phase 4 study of Ischemic Heart Disease, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01779869: Completed Phase 4 study of Ischemic Heart Disease, sponsored by Washington University School of Medicine.
NCT01779869 is a Phase 4 study of Ischemic Heart Disease that has completed, run by Washington University School of Medicine. The registered enrollment target is 16 participants, below the 265-participant average among 14 other Ischemic Heart Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01779869, a Phase 4 study of Ischemic Heart Disease, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective for this pilot study is to develop an optimized, clinically usable myocardial PET-MR perfusion protocol and to determine which of all data potentially available should be acquired for a clinical myocardial perfusion examination. Hypothesis: The hypothesis is that high resolution, high sensitivity DCE MRI could replace the rest PET myocardial perfusion imaging, significantly decreasing examination time and patient radiation dose while maintaining the comprehensive reference-quality PET myocardial stress perfusion coverage. The primary outcome will be comparison of diagnostic accuracy of each combination of imaging to detect clinically significant coronary artery stenosis (≥70% diameter stenosis).
Primary Outcome
The accuracy of the cardiac PET and cardiac MR examination components of the PET/MRI, and the accuracy of the combined PET/MR examination, for ischemic heart disease will be compared to the accuracy of cardiac SPECT in patients who have had ICA as "truth" or the reference standard. To assess the accuracy of an abbreviated PET/MR examination, an additional accuracy analysis was made using only the stress PET perfusion imaging and the MR LGE data sets. The accuracy of this combined data set was al
Conditions Studied
Interventions
- DRUG Regadenoson
Study Locations (1)
Missouri
- Center for Clinical Imaging Research at Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
What the finished NCT01779869 record still lists
NCT01779869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 265-participant average among 14 other Ischemic Heart Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Ischemic Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Regadenoson is the first listed.
NCT01779869 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT01779869 about?
NCT01779869 is a clinical study titled "Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson". The objective for this pilot study is to develop an optimized, clinically usable myocardial PET-MR perfusion protocol and to determine which of all data potentially available should be acquired for a clinical myocardial perfusion examination. Hypothesis: The hypothesis is that high resolution, high ...
What is the current status of trial NCT01779869?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2013-01. Estimated completion is 2015-06.
What conditions does trial NCT01779869 study?
This clinical trial studies the following conditions: Ischemic Heart Disease.
What interventions are being tested in trial NCT01779869?
The interventions under investigation include: Regadenoson (DRUG).
Who is sponsoring clinical trial NCT01779869?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01779869 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01779869's enrollment target sits among peer trials
16 15th of 14 the lowest of 14 other Ischemic Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ischemic Heart Disease 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.
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