CCTA Improves Clinical Management of Stable Chest Pain

Recruiting

• Conditions: Stable Chest Pain; Optimal Medical Therapy; Revascularization; Invasive Coronary Angiography; Major Adverse Cardiovascular Events; Coronary Artery Disease; Coronary Computed Tomography Angiography
• Interventions: Diagnostic Test: CCTA

• Registration Number: NCT04691037
• Lead Sponsor: Tianjin Chest Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CCTA	CCTA	-

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	10 years	Cardiac death and myocardial infarction

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Tianjin First Central Hospital; 🇨🇳 Tianjin, Tianjin, China

Hebei Petrochina Central Hospital; 🇨🇳 Langfang, Hebei, China

Tianjin Chest Hospital; 🇨🇳 Tianjin, Tianjin, China

Beijing Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China