NCT04691037

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jan 2016Jan 2030

Study Start

First participant enrolled

January 1, 2016

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

14 years

First QC Date

December 29, 2020

Last Update Submit

March 26, 2024

Conditions

Coronary Computed Tomography AngiographyStable Chest PainOptimal Medical TherapyInvasive Coronary AngiographyRevascularizationMajor Adverse Cardiovascular EventsCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events

    Cardiac death and myocardial infarction

    10 years

Secondary Outcomes (7)

  • Invasive coronary angiography

    10 years

  • Medication prescription

    10 years

  • Coronary revascularization

    10 years

  • Number of Participants with Death

    10 years

  • Number of Participants with Stroke

    3 years

  • +2 more secondary outcomes

Study Arms (1)

CCTA

Diagnostic Test: CCTA

Interventions

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.

CCTA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were referred for CCTA for the assessment of SCP suspected of CAD.

You may qualify if:

  • symptomatic patients with SCP suspected of obstructive CAD.
  • referred for CCTA for the assessment of SCP.
  • ≥18 years of age.
  • signed informed consent.

You may not qualify if:

  • acute coronary syndromes
  • previous CAD or coronary revascularization
  • nonsinus rhythm
  • cardiomyopathy, valvular disease, congenital heart disease or left cardiac insufficiency because of other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

RECRUITING

Hebei Petrochina Central Hospital

Langfang, Hebei, China

RECRUITING

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Related Publications (3)

  • Tan 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.

    PMID: 39076944DERIVED

  • Zhou 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.

    PMID: 37310243DERIVED

  • Jiang 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.

    PMID: 35345247DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Jia Zhou

CONTACT

+8615522485560zhoujiawenzhang@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 29, 2020

First Posted

December 31, 2020

Study Start

January 1, 2016

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

March 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)