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Evaluation of the Factors Affecting the Diagnostic Performance of Coronary Computed Tomography Angiogram (CTA) With Multi-slice Computed Tomography (MSCT)

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ClinicalTrials.gov Identifier: NCT01164839
Recruitment Status : Unknown
Verified July 2010 by Capital Medical University.
Recruitment status was:  Recruiting
First Posted : July 19, 2010
Last Update Posted : July 19, 2010
Information provided by:

Study Description
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.

Condition or disease
Coronary Artery Disease

Detailed Description:

Purpose Prospectively evaluating the factors affecting the diagnostic accuracy of coronary CTA with multi-slice CT (including 64-slice CT and dual-source CT) in detecting coronary stenosis, in comparison with quantitative X-ray coronary angiography, to establish the standard of image quality and associated parameters to ensure accurate diagnosis of coronary stenosis with coronary CTA.

Detailed Description Over the past few years, the development in CT technology, especially the introduction of 64-slice multi-slice CT (64 MSCT), has permitted the application of coronary CT angiography to detect coronary stenosis in suspected patients with coronary heart diseases. Now, coronary CT angiography has been widely used worldwide. However, the accuracy of coronary CT angiography is always a concern in decision making of proper treatment, especially in determining the existence of significant stenosis in patients with visible coronary arteriosclerosis.

Factors affecting the diagnostic accuracy may include spatial resolution, temporal resolution, motion artifacts, banding artifacts, image noise level, calcification, vessel enhancement, operator dependant factors, etc. One or more factors may affect the diagnosis performance in any single case. So it is important to determine the weighting of these factors in stenosis detection and the tolerance of diagnostic accuracy to these adverse factors.

Materials and methods

  1. Patient Population: About one thousand patients will be recruited over one year from our institution and other hospitals. All patients will undergo coronary CTA for suspected coronary artery disease. Then X-ray coronary angiography will be performed based on the impression on CTA findings from one radiologist (who will not participate the study) and/or clinical suspicion. Cases with both coronary CTA and X-ray coronary angiography in two weeks will be included. Our Institutional Review Board has approved the study. All patients will give informed consent. Patients with acute heart failure, severe arrhythmia and severe renal dysfunction will be excluded from cardiac studies.
  2. To identify stenosis, the coronary arteries of all cases were divided into 15 segments for evaluation with coronary CTA and SCA. Coronary stenosis was recorded as percentage narrowing of lumen diameter and degree of stenosis (without stenosis, mild stenosis (≦50%), moderate stenosis (51%~75%), and severe stenosis (100%)). Experienced radiologists and cardiologists make the assessment independently in a double blind manner. The result of SCA was used as gold standard.
  3. The process of coronary CTA examination of each recruited case will be carefully recorded to evaluate the factors that may affect the diagnostic performance of coronary CTA, such as heart rate, contrast injection parameters, delay time, optimal phase for reconstruction, etc. In addition, image quality will be evaluated, including the grading of motion artifact, banding artifact, enhancement, etc.
  4. To evaluate operator dependant factors, all the reformations of coronary CTA will be performed by two different operators. The reformed images will also be reviewed by two different observers to evaluate the stenosis, as well as the image quality factors (motion artifacts, banding artifacts, image noise level, calcification burden, vessel enhancement).
  5. Statistical analyses will be performed to evaluate the weighting of different factors in affecting the accuracy of coronary CTA.

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Factors Affecting the Diagnostic Performance of Coronary CTA With MSCT: a National Multicenter Trial
Study Start Date : July 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : December 2011
Groups and Cohorts

Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive eligible patients who undergo both coronary CTA and X-ray coronary angiography

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164839

Contact: Xiangying Du, MD, PhD 8613691042076 duxying@yahoo.com.cn

China, Beijing
Xuanwu Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Jie Liu         
Sub-Investigator: Pengyu Li, MD         
Sub-Investigator: Guisheng Wang, MD, PhD         
Sponsors and Collaborators
Capital Medical University
Beijing Meitan General Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Xinan Hospital, Third Military Medical University
Xinqiao Hospital of Chongqing
Guangxi Medical University
Guilin Medical College
The Second Affiliated Hospital of Harbin Medical University
Chinese PLA General Hospital
The First Affiliated Hospital of Kunming Medical College
Wuhan Union Hospital, China
Ningxia Medical University
Qinghai People's Hospital
The First Affiliated Hospital of Shanxi Medical University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Beijing Tongren Hospital
The Affiliated Hospital of Tianjin Medical University
Tang-Du Hospital
The First Affiliated Hospital of Zhengzhou University
First Hospital of China Medical University
Second Xiangya Hospital of Central South University
Shanghai Changzheng Hospital
LanZhou University
Beijing Armed Police General hospital
Study Director: Kuncheng Li, MD, PhD Xuanwu Hospital, Beijing
More Information

Responsible Party: Kuncheng Li, Xuanwu Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT01164839     History of Changes
Other Study ID Numbers: CCTA-CMUXW
First Posted: July 19, 2010    Key Record Dates
Last Update Posted: July 19, 2010
Last Verified: July 2010

Keywords provided by Capital Medical University:
coronary artery
CT angiography
image quality
multicenter trial

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases