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

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

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Jie Liu
      • Sub-Investigator: Pengyu Li, MD
      • Sub-Investigator: Guisheng Wang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: Guangxi Medical University; LanZhou University; Chinese PLA General Hospital; RenJi Hospital; Beijing Tongren Hospital; The First Affiliated Hospital of Zhengzhou University; Wuhan Union Hospital, China; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Xinqiao Hospital of Chongqing; The First Affiliated Hospital of Kunming Medical College; Tang-Du Hospital; First Hospital of China 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; Guilin Medical College; The Second Affiliated Hospital of Harbin Medical University; Ningxia Medical University; Qinghai People's Hospital; The First Affiliated Hospital of Shanxi Medical University; The Affiliated Hospital of Tianjin Medical University; Second Xiangya Hospital of Central South University; Shanghai Changzheng Hospital; Beijing Armed Police General hospital
• Investigators: Study Director: Kuncheng Li, MD, PhD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: July 16, 2010
• First Submitted That Met QC Criteria: July 16, 2010
• First Posted (Estimate): July 19, 2010

Study Record Updates

• Last Update Posted (Estimate): July 19, 2010
• Last Update Submitted That Met QC Criteria: July 16, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: CT angiography; coronary artery; image quality; multicenter trial
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CCTA-CMUXW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No