Coronary Artery DiseaseNCT01164839
Evaluation of the Factors Affecting the Diagnostic Performance of Coronary Computed Tomography Angiogram (CTA) With Multi-slice Computed Tomography (MSCT)
An observational study of Coronary Artery Disease, run by Capital Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive eligible patients who undergo both coronary CTA and X-ray coronary angiography
Who may be able to join
- 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
Who cannot join
- refuse or not capable of signing informed consent
- pregnant or nursing period
- acute heart failure
- severe arrhythmia
- allergic to iodine
- severe renal failure
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Jie Liu
Pengyu Li, MD
About this study
Official title: 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.
Read the 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
- 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.
- 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.
- 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.
- 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).
- Statistical analyses will be performed to evaluate the weighting of different factors in affecting the accuracy of coronary CTA.
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery, CT angiography, image quality, multicenter trial
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- 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, First Affiliated Hospital of Kunming Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Affiliated Hospital of Ningxia Medical College, 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
- Investigators
- Kuncheng Li, MD, PhD, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164839
- Sponsor's protocol ID
- CCTA-CMUXW
- Status last verified
- Jul 2010
- First submitted
- 16 Jul 2010
- Last updated
- 19 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Factors Affecting the Diagnostic Performance of Coronary CTA With MSCT: a National Multicenter Trial
- ClinicalTrials.gov ID
- NCT01164839
- Acronym / sponsor ID
- CCTA-CMUXW
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery, CT angiography, image quality, multicenter trial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- 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, First Affiliated Hospital of Kunming Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Affiliated Hospital of Ningxia Medical College, 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 start
- Jul 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- 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.
- 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.
- 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).
- Statistical analyses will be performed to evaluate the weighting of different factors in affecting the accuracy of coronary CTA.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive eligible patients who undergo both coronary CTA and X-ray coronary angiography
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- refuse or not capable of signing informed consent
- pregnant or nursing period
- acute heart failure
- severe arrhythmia
- allergic to iodine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2010.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuncheng Li, MD, PhD study director
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangying Du, MD, PhD (8613691042076, duxying@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2010.