Coronary Computed Tomography AngiographyCICM-SCPNCT04691037
CCTA Improves Clinical Management of Stable Chest Pain
An observational study of Coronary Computed Tomography Angiography and Stable Chest Pain, run by Tianjin Chest Hospital at 4 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Computed Tomography Angiography, Stable Chest Pain, Optimal Medical Therapy
- What is being tested?
- CCTA
- How many people
- 50,000 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2016to 1 Jan 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were referred for CCTA for the assessment of SCP suspected of CAD.
Who may be able to join
- symptomatic patients with SCP suspected of obstructive CAD.
- referred for CCTA for the assessment of SCP.
- ≥18 years of age.
- signed informed consent.
Who cannot join
- acute coronary syndromes
- previous CAD or coronary revascularization
- nonsinus rhythm
- cardiomyopathy, valvular disease, congenital heart disease or left cardiac insufficiency because of other reasons
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality
Yahang Tan, tanyahangwenzhang@126.com
- Recruiting
Hebei Petrochina Central Hospital
Langfang, Hebei
Tao Cheng, +8615303365846
- Recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300000
Jia Zhou, +15522485560, zhoujiawenzhang@126.com
- Recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality
Ting Xin, +8615102204614
About this study
Official title: 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.
- Conditions
- Coronary Computed Tomography Angiography, Stable Chest Pain, Optimal Medical Therapy, Invasive Coronary Angiography, Revascularization, Major Adverse Cardiovascular Events
- Being tested
- CCTA
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTADiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| CCTA | Not described Receives: Diagnostic Test: CCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Cardiac death and myocardial infarction
Measured: 10 years
Secondary outcomes (7)
Invasive coronary angiography
Invasive coronary angiography occurred at follow-up after CCTA, attributed to CCTA results or unplanned.
Measured: 10 years
Medication prescription
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,
Measured: 10 years
Coronary revascularization
PTCA, PCI or CABG occurred at follow-up after CCTA, attributed to CCTA results or unplanned.
Measured: 10 years
Number of Participants with Death
Measured: 10 years
Number of Participants with Stroke
Measured: 3 years
Number of Participants with Cardiac death
Measured: 10 years
Number of Participants with Myocardial infarction
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Jan 2016
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Computed Tomography AngiographyStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tianjin Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Jia, Tianjin Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691037
- Sponsor's protocol ID
- 2017-KY-004
- Acronym
- CICM-SCP
- Status last verified
- Mar 2024
- First submitted
- 29 Dec 2020
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang P, Chen T, He M, Xin T, Wang C, Zhao J, Tan Y, Zhou J. Comparison of coronary artery calcium score-based and all-coronary computed tomography angiography strategies in patients with stable chest pain and risk factor-weighted clinical likelihood of 5-15. BMC Med Imaging. 2026 Feb 20;26(1):161. doi: 10.1186/s12880-026-02232-3.
PubMed 41721263Tan Y, Liu C, Chen T, Li Y, Wang C, Zhao J, Zhou J. Coronary Artery Calcium Score-Weighted Clinical Likelihood Model Performance in Patients with Stable Chest Pain and Coronary Artery Calcium Scores of Zero. Rev Cardiovasc Med. 2024 Mar 4;25(3):85. doi: 10.31083/j.rcm2503085. eCollection 2024 Mar.
PubMed 39076944Zhou J, Li C, Zhang H, Liu C, Yang J, Zhao J, Hou Y, Tan Y, Wang H, Li Y, Xie C, Wang M, Wang C, Zhang E, Wang S, Zhao P, Shan D, Liang S, Gao Y, Huo Y, Cong H, Guo Z, Chen Y. Association between Coronary Artery Disease Reporting and Data System-recommended Post-Coronary CT Angiography Management and Clinical Outcomes in Patients with Stable Chest Pain from a Chinese Registry. Radiology. 2023 Jun;307(5):e222965. doi: 10.1148/radiol.222965.
PubMed 37310243Jiang H, Feng J, Feng C, Ren P, Ren K, Jin Y, Zhou J. Validation and Comparison of PROMISE and CONFIRM Model to Predict High-Risk Coronary Artery Disease in Symptomatic and Diabetes Mellitus Patients. Rev Cardiovasc Med. 2022 Mar 1;23(3):80. doi: 10.31083/j.rcm2303080.
PubMed 35345247
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Clinical Management of Stable Chest Pain Based on Imaging: a Registry of Computed Tomography Coronary Angiography
- ClinicalTrials.gov ID
- NCT04691037
- Acronym / sponsor ID
- CICM-SCP / 2017-KY-004
- Conditions
- Coronary Computed Tomography Angiography, Stable Chest Pain, Optimal Medical Therapy, Invasive Coronary Angiography, Revascularization, Major Adverse Cardiovascular Events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Tianjin Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 31 Dec 2020 (actual)
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCTA | – | Diagnostic Test: CCTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were referred for CCTA for the assessment of SCP suspected of CAD.
Key inclusion criteria (4 listed)
- symptomatic patients with SCP suspected of obstructive CAD.
- referred for CCTA for the assessment of SCP.
- ≥18 years of age.
- signed informed consent.
Key exclusion criteria (4 listed)
- acute coronary syndromes
- previous CAD or coronary revascularization
- nonsinus rhythm
- cardiomyopathy, valvular disease, congenital heart disease or left cardiac insufficiency because of other reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTAAll 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. | Diagnostic test | CCTA |
Primary outcome
Major adverse cardiovascular events
Time frame: 10 years
Cardiac death and myocardial infarction
7 secondary outcomes
Invasive coronary angiography
Time frame: 10 years
Medication prescription
Time frame: 10 years
Coronary revascularization
Time frame: 10 years
Number of Participants with Death
Time frame: 10 years
Number of Participants with Stroke
Time frame: 3 years
Number of Participants with Cardiac death
Time frame: 10 years
Number of Participants with Myocardial infarction
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 41721263Wang P, Chen T, He M, Xin T, Wang C, Zhao J, Tan Y, Zhou J. Comparison of coronary artery calcium score-based and all-coronary computed tomography angiography strategies in patients with stable chest pain and risk factor-weighted clinical likelihood of 5-15. BMC Med Imaging. 2026 Feb 20;26(1):161. doi: 10.1186/s12880-026-02232-3.
- Derived from this study: PubMed 39076944Tan Y, Liu C, Chen T, Li Y, Wang C, Zhao J, Zhou J. Coronary Artery Calcium Score-Weighted Clinical Likelihood Model Performance in Patients with Stable Chest Pain and Coronary Artery Calcium Scores of Zero. Rev Cardiovasc Med. 2024 Mar 4;25(3):85. doi: 10.31083/j.rcm2503085. eCollection 2024 Mar.
- Derived from this study: PubMed 37310243Zhou J, Li C, Zhang H, Liu C, Yang J, Zhao J, Hou Y, Tan Y, Wang H, Li Y, Xie C, Wang M, Wang C, Zhang E, Wang S, Zhao P, Shan D, Liang S, Gao Y, Huo Y, Cong H, Guo Z, Chen Y. Association between Coronary Artery Disease Reporting and Data System-recommended Post-Coronary CT Angiography Management and Clinical Outcomes in Patients with Stable Chest Pain from a Chinese Registry. Radiology. 2023 Jun;307(5):e222965. doi: 10.1148/radiol.222965.
- Derived from this study: PubMed 35345247Jiang H, Feng J, Feng C, Ren P, Ren K, Jin Y, Zhou J. Validation and Comparison of PROMISE and CONFIRM Model to Predict High-Risk Coronary Artery Disease in Symptomatic and Diabetes Mellitus Patients. Rev Cardiovasc Med. 2022 Mar 1;23(3):80. doi: 10.31083/j.rcm2303080.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Computed Tomography Angiography and Stable Chest Pain, run by Tianjin Chest Hospital at 4 sites 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 4 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: looking for participants now, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Zhou (+8615522485560, zhoujiawenzhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04691037, which also lists 4 linked publications.
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 28 Mar 2024.