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

NCT05431309 | Not Yet Recruiting

• 1 other identifier: ZRui
• Study Type: interventional
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Primary Prevention Strategy

Outcome Measures

Primary Outcomes (1)

• The first occurrence of coronary heart disease

  Composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure.

  5 years

Secondary Outcomes (20)

• Major cardiovascular adverse events (MACE)

  5 years

• Death

  5 years

• Occurrence of serious adverse events related to iodinated contrast agent

  1 year

• Coronary interventions

  5 years

• The primary end point(composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure) in different subgroups

  5 years

Study Arms (2)

CCTA-based strategy group

ACTIVE COMPARATOR

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

Diagnostic Test: Coronary Computed Tomography Angiography

Traditional strategy group

SHAM COMPARATOR

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

Other: Standard Treatment

Interventions

Coronary Computed Tomography Angiography DIAGNOSTIC_TEST

Intervention strategies were selected according to CCTA results

CCTA-based strategy group

Standard Treatment OTHER

Traditional cardiovascular disease prevention strategy based on Chinese guideline

Traditional strategy group

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Officials

• Trial Manager

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

  STUDY CHAIR

Central Study Contacts

Longjiang Zhang, MD

CONTACT

+8613405833176; kevinzhlj@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator : Zhang longjiang

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 24, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share