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

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of the Factors Affecting the Diagnostic Performance of Coronary CTA With MSCT: a National Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01164839
• Other study ID #: CCTA-CMUXW
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2010
• Last updated: July 16, 2010
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2010
• Source: Capital Medical University
• Contact: Xiangying Du, MD, PhD
• Phone: 8613691042076
• Email: duxying[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (25)

Lead Sponsor

Collaborator

Capital Medical University

Beijing Armed Police General hospital, Beijing Meitan General Hospital, Beijing Tongren Hospital, Chinese PLA General Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Hospital of China Medical University, Guangxi Medical University, Guilin Medical College, LanZhou University, Ningxia Medical University, Qinghai People's Hospital, RenJi Hospital, Second Xiangya Hospital of Central South University, Shanghai Changzheng Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Tang-Du Hospital, The Affiliated Hospital of Tianjin Medical University, The First Affiliated Hospital of Kunming Medical College, The First Affiliated Hospital of Shanxi Medical University, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Harbin Medical University, Wuhan Union Hospital, China, Xinan Hospital, Third Military Medical University, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China,