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NCT01890434 · ClinicalTrials.gov registry record · Phase 3
Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
A Phase 3 study of Coronary Artery Disease, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 478
- Enrollment target
- 20
- Study locations
NCT01890434: Completed Phase 3 study of Coronary Artery Disease, sponsored by Bayer.
NCT01890434 is a Phase 3 study of Coronary Artery Disease that has completed, run by Bayer. The registered enrollment target is 478 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01890434, a Phase 3 study of Coronary Artery Disease, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
- 20
- Study locations
Study Summary
Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a subject in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. The primary objective of this study is to demonstrate that sensitivity and specificity of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD. The CMR images acquired with a uniform imaging acquisition software will be evaluated either against the results from routine clinical Coronary Angiography (CA) or Computed Tomography Angiography (CTA), which are the standard of reference. CMRI and CA/CTA images will be collected for an independent image review (blinded read).
Primary Outcome
Blinded readers evaluated 6 myocardial regions based on regional perfusion score \[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angi
Conditions Studied
Interventions
- DRUG Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Study Locations (20)
Maryland
- - Bethesda
- - Bethesda
Ohio
- - Cleveland
- - Columbus
Other
- - Chermside
- - North Adelaide
Arizona
- - Tucson
California
- - Los Angeles
Georgia
- - Atlanta
Illinois
- - Chicago
Massachusetts
- - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2013-08-26 |
| Est. Completion | 2016-11-10 |
| Phase | Phase 3 |
What the finished NCT01890434 record still lists
NCT01890434 is an interventional study that assigns participants to a tested intervention. The registered 478 participants enrollment target is mid-sized for trials with a published cap, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Gadobutrol (Gadavist, Gadovist, BAY86-4875) is the first listed.
NCT01890434 names 20 study sites across 17 states, led by Maryland, Ohio, Other.
Frequently Asked Questions
What is clinical trial NCT01890434 about?
NCT01890434 is a clinical study titled "Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)". Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a subject in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. The primary...
What is the current status of trial NCT01890434?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2013-08-26. Estimated completion is 2016-11-10.
What conditions does trial NCT01890434 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT01890434?
The interventions under investigation include: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (DRUG).
Who is sponsoring clinical trial NCT01890434?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01890434 being conducted?
This trial has 20 study locations across Arizona, California, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01890434's enrollment target sits among peer trials
478 77th of 219 higher than 143 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery 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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