Contrast-Enhanced Whole-Heart Coronary Magnetic Resonance... | NCT01024478

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

NCT01024478

Sponsor

Capital Medical University

Status

Completed

Last Update Posted

Jul 7, 2011Estimated

Enrollment

272Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Dec 1, 2009

First Submission Date that Met QC Criteria

Dec 1, 2009

First Posted Date

Dec 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2011

Last Update Posted Date

Jul 7, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Capital Medical UniversityOTHER

Collaborators

Name	Class
Fujian Medical University Union Hospital	OTHER
Air Force Military Medical University, China	OTHER
Huazhong University of Science and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

272Actual

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Consecutive eligible patients scheduled to undergo conventional coronary angiography.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
kuncheng li, M.D.	Xuanwu Hospital, Beijing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radiology Department of Xuanwu Hopital		Beijing	Beijing Municipality	100053	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19555843	Background	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.

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases