NCT05431309

Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease

Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease: a Community-based, Prospective Randomised Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15,000 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 40 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy will be superior to traditional CHD prevention strategy, in reducing the future risk of CHD which included myocardial infarction, angina, cardiac death, and an emergency/urgent coronary revascularisation procedure, in a community population aged 40 to 69 years with cardiovascular risk factors but no history of cardiovascular disease.

Detailed description

Recent studies found that the incidence of CAD, screening with CCTA, in the general population is as high as 42%\~49%. However, the effectiveness of CCTA screening in the primary prevention of CHD is unclear. The investigators designed a randomized controlled, open-label, pragmatic study to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy will be superior to traditional CHD prevention strategy. Community volunteers aged 40 to 69 years who provide consent, and are eligible (with cardiovascular risk factors but no history of cardiovascular disease), will be randomized 1:1 to receive individualized primary prevention programs for CHD, including statin recommendation, based on CCTA results or traditional risk assessment results using the Chinese guideline on the primary prevention of cardiovascular diseases-recommended strategy. All subjects will be followed for 5 years, but until the target primary endpoint event is met. The primary composite outcome was the first occurrence of CHD, which included myocardial infarction, angina, cardiac death, and an emergency/urgent coronary revascularisation procedure. In order to prepare the study with high quality, the investigators will performed a pilot study prior to the initiation of patient recruitment for the main study.

Conditions

• Cardiovascular Primary Prevention Strategy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coronary Computed Tomography Angiography	Intervention strategies were selected according to CCTA results
OTHER	Standard Treatment	Traditional cardiovascular disease prevention strategy based on Chinese guideline

Timeline

• Start date: 2022-07-01
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2022-06-24
• Last updated: 2022-07-07