CICM-SCP: CCTA Improves Clinical Management of Stable Chest Pain

Sponsor
Tianjin Chest Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04691037
Collaborator
(none)
50,000
2
168
25000
148.8

Study Details

Study Description

Brief 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). 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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Improving the Clinical Management of Stable Chest Pain Based on Imaging: a Registry of Computed Tomography Coronary Angiography
Actual Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2030
Anticipated Study Completion Date :
Jan 1, 2030

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Major adverse cardiovascular events [3 years]

    Cardiac death and myocardial infarction

Secondary Outcome Measures

  1. Invasive coronary angiography [3 years]

    Invasive coronary angiography occurred at follow-up after CCTA, attributed to CCTA results or unplanned.

  2. Medication prescription [3 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,

  3. Coronary revascularization [3 years]

    PTCA, PCI or CABG occurred at follow-up after CCTA, attributed to CCTA results or unplanned.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • missing data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Chaoyang Hospital Beijing China
2 Tianjin Chest Hospital Tianjin China 300000

Sponsors and Collaborators

  • Tianjin Chest Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhou Jia, Doctor, Tianjin Chest Hospital
ClinicalTrials.gov Identifier:
NCT04691037
Other Study ID Numbers:
  • TJCHCCTA-01
First Posted:
Dec 31, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022