Coronary Artery DiseaseNCT01024478
Contrast-Enhanced Whole-Heart Coronary Magnetic Resonance Angiography at 3.0-T: A Multicenter Trial
An observational study of Coronary Artery Disease, run by Capital Medical University at 1 site in China.
Trial summary
The multicenter study evaluates the diagnostic performance of 3.0 T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- Oct 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive eligible patients scheduled to undergo conventional coronary angiography.
Who may be able to join
- Suspected CAD, scheduled for DSA
- Sinus rhythm
Who cannot join
- Contraindications to MR examination: pacemaker, intraauricular implants, intracranial clips, thoracotomy, claustrophobia, orthopnea
- Acute coronary syndrome
- Atria fibrillation
- Coronary stents
- Bypass grafts
- Renal insufficiency (estimated glomerular filtration rate assessed by creatinine clearance <60 ml/min/1.73 m2)
Trial locations and contacts
1 site in 1 country.
China1 site
Radiology Department of Xuanwu Hopital
Beijing, Beijing Municipality, 100053
About this study
The multicenter study evaluates the diagnostic performance of 3.0 T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease.
Read the detailed description
This is a multicenter trial evaluated the diagnostic ability of 3.0 T contrast-enhanced whole-heart coronary MRA to detect significant coronary artery stenosis among patients with suspected CAD.
A total of 272 patients will be prospectively enrolled from 8 cities in China.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery, Magnetic Resonance Angiography, Coronary Artery disease, Multicenter Trial, Cardiac MRI
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, Air Force Military Medical University, China, Huazhong University of Science and Technology, Nanjing Medical University, First Affiliated Hospital, Sun Yat-Sen University, Henan Provincial People's Hospital, Fudan University
- Investigators
- kuncheng li, M.D., Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024478
- Sponsor's protocol ID
- CapitalMedicalU
- Status last verified
- Dec 2009
- First submitted
- 1 Dec 2009
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang Q, Li K, Liu X, Bi X, Liu Z, An J, Zhang A, Jerecic R, Li D. Contrast-enhanced whole-heart coronary magnetic resonance angiography at 3.0-T: a comparative study with X-ray angiography in a single center. J Am Coll Cardiol. 2009 Jun 30;54(1):69-76. doi: 10.1016/j.jacc.2009.03.016.
PubMed 19555843
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced Whole-Heart Coronary Magnetic Resonance Angiography at 3.0-T: A Multicenter Trial
- ClinicalTrials.gov ID
- NCT01024478
- Acronym / sponsor ID
- CapitalMedicalU
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery, Magnetic Resonance Angiography, Coronary Artery disease, Multicenter Trial, Cardiac MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, Air Force Military Medical University, China, Huazhong University of Science and Technology, Nanjing Medical University, First Affiliated Hospital, Sun Yat-Sen University, Henan Provincial People's Hospital, Fudan University
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The multicenter study evaluates the diagnostic performance of 3.0 T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease.
Detailed description
This is a multicenter trial evaluated the diagnostic ability of 3.0 T contrast-enhanced whole-heart coronary MRA to detect significant coronary artery stenosis among patients with suspected CAD.
A total of 272 patients will be prospectively enrolled from 8 cities in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive eligible patients scheduled to undergo conventional coronary angiography.
Key inclusion criteria (2 listed)
- Suspected CAD, scheduled for DSA
- Sinus rhythm
Key exclusion criteria (6 listed)
- Contraindications to MR examination: pacemaker, intraauricular implants, intracranial clips, thoracotomy, claustrophobia, orthopnea
- Acute coronary syndrome
- Atria fibrillation
- Coronary stents
- Bypass grafts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
- Background: PubMed 19555843Yang Q, Li K, Liu X, Bi X, Liu Z, An J, Zhang A, Jerecic R, Li D. Contrast-enhanced whole-heart coronary magnetic resonance angiography at 3.0-T: a comparative study with X-ray angiography in a single center. J Am Coll Cardiol. 2009 Jun 30;54(1):69-76. doi: 10.1016/j.jacc.2009.03.016.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kuncheng li, M.D. principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01024478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2011.