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

Study Locations

  • China
    • Beijing
    • 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

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
Diagnostic test: 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

Tianjin Chest Hospital

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.

General Publications

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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