Clinical trial NCT04691037: CCTA Improves Clinical Management of Stable Chest Pain
Official title: Improving the Clinical Management of Stable Chest Pain Based on Imaging: a Registry of Computed Tomography Coronary Angiography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Computed Tomography Angiography
Stable Chest Pain
Optimal Medical Therapy
Invasive Coronary Angiography
Revascularization
Major Adverse Cardiovascular Events
Coronary Artery Disease
Lead sponsor: Tianjin Chest Hospital
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were referred for CCTA for the assessment of SCP suspected of CAD.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 10 years
Secondary outcomes:
measure: Invasive coronary angiography
timeFrame: 10 years
measure: Medication prescription
timeFrame: 10 years
measure: Coronary revascularization
timeFrame: 10 years
measure: Number of Participants with Death
timeFrame: 10 years
measure: Number of Participants with Stroke
timeFrame: 3 years
measure: Number of Participants with Cardiac death
timeFrame: 10 years
measure: Number of Participants with Myocardial infarction
timeFrame: 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Langfang
country: China
facility: Hebei Petrochina Central Hospital
state: Hebei
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
Study officials:
References:
citation: 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.