NCT01164839

Brief Summary

The multicenter study evaluates the diagnostic performance of coronary Computed Tomography Angiogram (CTA) with multi-slice computed tomography (MSCT) in comparison with X-ray coronary angiography and the factors affecting the accuracy of coronary CTA in diagnosing stenosis of coronary arteries. Furthermore, the study tends to establish the standard of image quality and associated factors that may ensure accurate diagnosis of coronary stenosis with coronary CTA.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 19, 2010

Status Verified

July 1, 2010

Enrollment Period

11 months

First QC Date

July 16, 2010

Last Update Submit

July 16, 2010

Conditions

Coronary Artery Disease

Keywords

coronary arteryCT angiographyimage qualitymulticenter trial

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive eligible patients who undergo both coronary CTA and X-ray coronary angiography

You may qualify if:

  • aged 20 years to 80 years
  • suspected of coronary artery disease
  • capable of cooperation during coronary CT angiography
  • with X-ray coronary angiography within 2 weeks after coronary CTA

You may not qualify if:

  • refuse or not capable of signing informed consent
  • pregnant or nursing period
  • acute heart failure
  • severe arrhythmia
  • allergic to iodine
  • severe renal failure
  • not capable of breathholding
  • acute myocardial infarction or previous myocardial infarction
  • previous stent implantation
  • change of clinical status between coronary CTA and X-ray coronary angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Kuncheng Li, MD, PhD

    Xuanwu Hospital, Beijing

    STUDY DIRECTOR

Central Study Contacts

Xiangying Du, MD, PhD

CONTACT

8613691042076duxying@yahoo.com.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 19, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

July 19, 2010

Record last verified: 2010-07

Locations

CN(1)