CCTA Improves Clinical Management of Stable Chest Pain (CICM-SCP)

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: Coronary Artery Disease; Major Adverse Cardiovascular Events; Coronary Computed Tomography Angiography; Revascularization; Stable Chest Pain; Optimal Medical Therapy; Invasive Coronary Angiography
• Intervention / Treatment: Diagnostic test: CCTA

• Study Type: Observational
• Enrollment (Estimated): 50000

Contacts and Locations

• Study Contact: Name: Jia Zhou; Phone Number: +8615522485560; Email: zhoujiawenzhang@126.com

Study Locations

• China
  • 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

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

How is the study designed?

Number of groups / cohorts

1

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	Cardiac death and myocardial infarction	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive coronary angiography	Invasive coronary angiography occurred at follow-up after CCTA, attributed to CCTA results or unplanned.	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,	10 years
Coronary revascularization	PTCA, PCI or CABG occurred at follow-up after CCTA, attributed to CCTA results or unplanned.	10 years
Number of Participants with Death		10 years
Number of Participants with Stroke		3 years
Number of Participants with Cardiac death		10 years
Number of Participants with Myocardial infarction		10 years

Collaborators and Investigators

• Sponsor: Tianjin Chest Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

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: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Coronary Artery Disease; Chest Pain
• 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