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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00155012
Other study ID # 9361700491
Secondary ID NSC-93-2314-B-00
Status Recruiting
Phase Phase 3
First received September 9, 2005
Last updated September 9, 2005
Start date August 2004
Est. completion date August 2006

Study information

Verified date April 2004
Source National Taiwan University Hospital
Contact Wen-jeng Lee, M.D.
Phone 88623562604
Email jacklee@ntumc.org
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

1) Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of coronary CT angiography and the influence of coronary calcium score on coronary CT angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.


Description:

Computed tomography is evolving as a tool for noninvasive diagnosis of coronary artery disease. Coronary calcium deposition amount is an established independent coronary artery disease risk factor. However, coronary artery stenosis seldom occurred in the same location as calcium deposition. With the advent of 16-detector-row multislice spiral CT, direct visualization of coronary artery is possible. But it remains a great challenge to obtain diagnostic quality image in the beating heart. Small distal vessels may not be adequately visualized. Artifacts from severe calcification or coronary stent may render diagnosis difficult. The clinical implication of coronary calcium score, indication of coronary CT angiography and myocardial enhancement measurement should be further studied. The purposes of this study are: 1) Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of coronary CT angiography and the influence of coronary calcium score on coronary CT angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- coronary artery disease admitted for coronary angiography

Exclusion Criteria:

- Heart failure, irregular heart rate

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

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