CCTA Improves Clinical Management of Stable Chest Pain

Coronary Artery Disease Clinical Trial

— CICM-SCP  

Official title:

Improving the Clinical Management of Stable Chest Pain Based on Imaging: a Registry of Computed Tomography Coronary Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691037
• Other study ID #: 2017-KY-004
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: January 1, 2030

Study information

• Verified date: March 2024
• Source: Tianjin Chest Hospital
• Contact: Jia Zhou
• Phone: +8615522485560
• Email: zhoujiawenzhang[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Coronary Artery Disease
• Coronary Computed Tomography Angiography
• Invasive Coronary Angiography
• Major Adverse Cardiovascular Events
• Optimal Medical Therapy
• Revascularization
• Stable Chest Pain

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing
China	Hebei Petrochina Central Hospital	Langfang	Hebei
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	Tianjin First Central Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events	Cardiac death and myocardial infarction	10 years
Secondary	Invasive coronary angiography	Invasive coronary angiography occurred at follow-up after CCTA, attributed to CCTA results or unplanned.	10 years
Secondary	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
Secondary	Coronary revascularization	PTCA, PCI or CABG occurred at follow-up after CCTA, attributed to CCTA results or unplanned.	10 years
Secondary	Number of Participants with Death		10 years
Secondary	Number of Participants with Stroke		3 years
Secondary	Number of Participants with Cardiac death		10 years
Secondary	Number of Participants with Myocardial infarction		10 years