Status:
NOT_YET_RECRUITING
Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease
Lead Sponsor:
Jinling Hospital, China
Conditions:
Cardiovascular Primary Prevention Strategy
Eligibility:
All Genders
40-69 years
Phase:
NA
Brief 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 p...
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 ...
Eligibility Criteria
Inclusion
- Resident population aged 40-69 in Nanjing, China
- One or more of the following cardiovascular disease risk factors must be present, as follows:
- Current or recent (within 12 months) smoker
- Clinical diagnosis of hypertension (\>140/90mmHg)
- Hypercholesterolaemia (LDL≥4.1mmol/L or total cholesterol\>6.0 mmol/L, including familial hypercholesterolaemia)
- Diabetes mellitus
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease, males, age\<55 years; females, age\<60 years)
- Chronic kidney disease stage 3 (eGFR 30\~59mL/min/1.73 m2)
Exclusion
- Plan to leave Nanjing within 5 years or be unable to complete the follow-up work
- Refuse to sign informed consent or inability to understand and comply with the program process
- Known atherosclerotic cardiovascular disease (eg. angina, coronary heart disease, stroke, transient ischemic attack, peripheral vascular disease)
- Serious chronic kidney disease (eGFR\< 30 ml/min/1.73 m2)
- Serious liver disease or dysfunction (chronic active hepatitis and cirrhosis, or aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal)
- Prior coronary computed tomography angiography or invasive coronary angiography within the last 5 years
- Not appropriate to be tested due to birth planning, allergies, acute thyroid storm, etc
- Current use of statin therapy
- Patients with diseases that seriously affect the survival period, such as malignant tumors
- Other conditions at the discretion of the research group
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT05431309
Start Date
July 1 2022
End Date
November 30 2028
Last Update
July 7 2022
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