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NCT01024478 Clinical Trial

Contrast-Enhanced Whole-Heart Coronary Magnetic Resonance Angiography at 3.0-T: A Multicenter Trial

Coronary Artery Disease Clinical Trial

Official title:
Contrast-Enhanced Whole-Heart Coronary Magnetic Resonance Angiography at 3.0-T: A Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01024478
Other study ID # CapitalMedicalU
Secondary ID
Status Completed
Phase N/A
First received December 1, 2009
Last updated July 6, 2011
Start date October 2009
Est. completion date September 2010

Study information
Verified date December 2009
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 272
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Suspected CAD, scheduled for DSA

- Sinus rhythm

Exclusion Criteria:

- 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Radiology Department of Xuanwu Hopital Beijing Beijing

Sponsors (8)
Lead Sponsor Collaborator
Capital Medical University First Affiliated Hospital, Sun Yat-Sen University, Fourth Military Medical University, Fudan University, Fujian Medical University, Henan Provincial Hospital, Huazhong University of Science and Technology, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Erratum in: J Am Coll Cardiol. 2009 Nov 10;54(20):1902. — View Citation

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