Clinical trial NCT05431309: Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease
Official title: Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease: a Community-based, Prospective Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Primary Prevention Strategy
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 15000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

1. Resident population aged 40-69 in Nanjing, China
2. One or more of the following cardiovascular disease risk factors must be present, as follows:

   1. Current or recent (within 12 months) smoker
   2. Clinical diagnosis of hypertension (\>140/90mmHg)
   3. Hypercholesterolaemia (LDL≥4.1mmol/L or total cholesterol\>6.0 mmol/L, including familial hypercholesterolaemia)
   4. Diabetes mellitus
   5. Rheumatoid arthritis
   6. Systemic lupus erythematosus
   7. Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease, males, age\<55 years; females, age\<60 years)
   8. Chronic kidney disease stage 3 (eGFR 30\~59mL/min/1.73 m2)

Exclusion Criteria:

1. Plan to leave Nanjing within 5 years or be unable to complete the follow-up work
2. Refuse to sign informed consent or inability to understand and comply with the program process
3. Known atherosclerotic cardiovascular disease (eg. angina, coronary heart disease, stroke, transient ischemic attack, peripheral vascular disease)
4. Serious chronic kidney disease (eGFR\< 30 ml/min/1.73 m2)
5. 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)
6. Prior coronary computed tomography angiography or invasive coronary angiography within the last 5 years
7. Not appropriate to be tested due to birth planning, allergies, acute thyroid storm, etc
8. Current use of statin therapy
9. Patients with diseases that seriously affect the survival period, such as malignant tumors
10. Other conditions at the discretion of the research group

Primary outcomes:
measure: The first occurrence of coronary heart disease
timeFrame: 5 years
Secondary outcomes:
measure: Major cardiovascular adverse events (MACE)
timeFrame: 5 years
measure: Death
timeFrame: 5 years
measure: Occurrence of serious adverse events related to iodinated contrast agent
timeFrame: 1 year
measure: Coronary interventions
timeFrame: 5 years
measure: The primary end point(composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure) in different subgroups
timeFrame: 5 years
measure: Diet
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Exercise
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Smoking cessation
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Change in cardiovascular risk factors (blood pressure)
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Change in cardiovascular risk factors (lipids)
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Change in cardiovascular risk factors (body weight)
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Change in cardiovascular risk factors(waist circumference)
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Change in depression (PHQ-9)
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Change in anxiety (GAD-7)
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Change in quality of sleep(PSQI)
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Change in quality of life(SF-12)
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Incidental findings in Computed Tomography Angiography group
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Medication adherence( anti-hypertension agent, hypoglycemic agent, antilipemic agents, anti-platelet, etc.)
timeFrame: at 1-year follow-up and final follow-up (5 years)
measure: Health economics
timeFrame: 5 years
measure: Disadvantages of Radiation exposure
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
name: Trial Manager
role: STUDY_CHAIR
References: