Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
Public ClinicalTrials.gov record NCT01890434. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter Open-label Study to Evaluate Efficacy of Gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Significant Coronary Artery Disease (CAD) in Subjects With Known or Suspected CAD by a Blinded Image Analysis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01890434
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 478 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 26, 2013 (Actual)
- Primary completion
- Aug 6, 2016 (Actual)
- Completion
- Nov 10, 2016 (Actual)
- Last update posted
- Jul 31, 2019
2013 – 2016
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Tucson | Arizona | 85724 | — |
| Not listed | Los Angeles | California | 90048-0750 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Chicago | Illinois | 60611-2908 | — |
| Not listed | Bethesda | Maryland | 20814 | — |
| Not listed | Bethesda | Maryland | 20892 | — |
| Not listed | Boston | Massachusetts | 02114 | — |
| Not listed | St Louis | Missouri | 63110 | — |
| Not listed | Durham | North Carolina | 27710 | — |
| Not listed | Cleveland | Ohio | 44195 | — |
| Not listed | Columbus | Ohio | 43210 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Charleston | South Carolina | 29425 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01890434, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2019 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01890434 live on ClinicalTrials.gov.