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

NCT ID: NCT05431309

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2028-11-30

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.

Conditions

Cardiovascular Primary Prevention Strategy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

CCTA-based strategy group

Patients will be managed following the CCTA -based coronary heart disease prevention strategy for statin initiation and follow-up.

Group Type: ACTIVE_COMPARATOR

Coronary Computed Tomography Angiography

Intervention Type: DIAGNOSTIC_TEST

Intervention strategies were selected according to CCTA results

Traditional strategy group

Patients will be managed following the Traditional cardiovascular disease prevention strategy based on Chinese guideline for statin initiation and follow-up.

Group Type: SHAM_COMPARATOR

Standard Treatment

Intervention Type: OTHER

Traditional cardiovascular disease prevention strategy based on Chinese guideline

Interventions

Coronary Computed Tomography Angiography

Intervention strategies were selected according to CCTA results

Intervention Type: DIAGNOSTIC_TEST

Standard Treatment

Traditional cardiovascular disease prevention strategy based on Chinese guideline

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Zhang longjiang,MD

Principal Investigator : Zhang longjiang

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trial Manager

Role: STUDY_CHAIR

Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.

Central Contacts

Longjiang Zhang, MD

Role: CONTACT

kevinzhlj@163.com

+8613405833176

Other Identifiers

ZRui

Identifier Type: -

Identifier Source: org_study_id