- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04691037
CCTA Improves Clinical Management of Stable Chest Pain (CICM-SCP)
March 26, 2024 updated by: Zhou Jia, Tianjin Chest Hospital
Improving the Clinical Management of Stable Chest Pain Based on Imaging: a Registry of Computed Tomography Coronary Angiography
The investigator aims to prospectively enroll patients who were referred for coronary computed tomography angiography (CCTA) for the assessment of stable chest pain (SCP) suspected of obstructive coronary artery disease (CAD).
All patients underwent CCTA according to established guidelines and local institutional protocols.
The imaging data were evaluated using different image post-processing software to comprehensively analyse anatomical, functional and histological information of coronary.
This study will determine if CCTA-based imaging evaluation can provide more informaton to improve clinical management for SCP, including fewer MACE and better decision-making of downstream investigations and therapeutic interventions.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
50000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jia Zhou
- Phone Number: +8615522485560
- Email: zhoujiawenzhang@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Beijing ChaoYang Hospital
-
Contact:
- Yahang Tan
- Email: tanyahangwenzhang@126.com
-
-
Hebei
-
Langfang, Hebei, China
- Recruiting
- Hebei Petrochina Central Hospital
-
Contact:
- Tao Cheng
- Phone Number: +8615303365846
-
-
Tianjin
-
Tianjin, Tianjin, China
- Recruiting
- Tianjin First Central Hospital
-
Contact:
- Ting Xin
- Phone Number: +8615102204614
-
Tianjin, Tianjin, China, 300000
- Recruiting
- Tianjin Chest Hospital
-
Contact:
- Jia Zhou
- Phone Number: +15522485560
- Email: zhoujiawenzhang@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who were referred for CCTA for the assessment of SCP suspected of CAD.
Description
Inclusion Criteria:
- symptomatic patients with SCP suspected of obstructive CAD.
- referred for CCTA for the assessment of SCP.
- ≥18 years of age.
- signed informed consent.
Exclusion Criteria:
- acute coronary syndromes
- previous CAD or coronary revascularization
- nonsinus rhythm
- cardiomyopathy, valvular disease, congenital heart disease or left cardiac insufficiency because of other reasons
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CCTA
|
All patients underwent CCTA according to established guidelines and local institutional protocols.
The imaging data were evaluated using different image post-processing software to comprehensively analyse anatomical, functional and histological information of coronary.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiovascular events
Time Frame: 10 years
|
Cardiac death and myocardial infarction
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Invasive coronary angiography
Time Frame: 10 years
|
Invasive coronary angiography occurred at follow-up after CCTA, attributed to CCTA results or unplanned.
|
10 years
|
Medication prescription
Time Frame: 10 years
|
Change for medication prescription of antiplatelet agents, anti-ischemic drugs, lipid-lowering agents, angiotensin-converting enzyme inhibition and so on, attributed to CCTA results or unplanned,
|
10 years
|
Coronary revascularization
Time Frame: 10 years
|
PTCA, PCI or CABG occurred at follow-up after CCTA, attributed to CCTA results or unplanned.
|
10 years
|
Number of Participants with Death
Time Frame: 10 years
|
10 years
|
|
Number of Participants with Stroke
Time Frame: 3 years
|
3 years
|
|
Number of Participants with Cardiac death
Time Frame: 10 years
|
10 years
|
|
Number of Participants with Myocardial infarction
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2030
Study Registration Dates
First Submitted
December 29, 2020
First Submitted That Met QC Criteria
December 29, 2020
First Posted (Actual)
December 31, 2020
Study Record Updates
Last Update Posted (Actual)
March 28, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-KY-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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