Role of Coronary CTA on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population

Adherence, Medication Clinical Trial

— RESPECT2  

Official title:

Role of the Screening With Coronary Computed Tomography Angiography on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population: a Community-based, Prospective Randomised Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725096
• Other study ID #: 2022DZKY-056-01
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: Jinling Hospital, China
• Contact: Longjiang Zhang, MD
• Phone: 13405833167
• Email: kevinzhlj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy improves lipid-lowering treatment and cardiovascular risk factor control compared with traditional CHD prevention strategy, guided by a cardiovascular risk score.

Description:

At present, doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the RESPECT study the investigator will compare this "risk score" to coronary CTA scan. In this study the investigator would like to determine the effect of coronary CTA scan on lipid-lowering treatment and cardiovascular risk factor control.

This study will recruit 3400 eligible community volunteers (asymptomatic individuals free of any known cardiovascular event) aged 40 to 69 years, then, randomized (1:1) them to receive individualized primary prevention programs for coronary heart disease based on CCTA results or traditional risk score, as recommended in the Chinese CVD prevention guidelines. The intervention strategies in this study are consistent with RESPECT trial.

The investigator will assess the difference of lipid-lowering treatment and cardiovascular risk factor control between two groups 12 months later. Furthermore, the investigator will present the results of subclinical coronary atherosclerosis in participants who have undergone coronary CTA scans. This will help us understand the prevalence of subclinical coronary atherosclerotic disease in an asymptomatic Chinese population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3400
• Est. completion date: June 2027
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

Inclusion Criteria:

1. Nanjing residents who have no plans to leave in the next 5 years

2. Aged from 40 to 69 years

3. Free of any known clinically cardiovascular disease Able to comprehend and sign an informed consent form

Exclusion Criteria:

1. Serious liver dysfunction, defined as AST or ALT > 3 times the normal upper limit

2. Chronic kidney disease (CKD) > stage 4, defined as eGFR < 30 ml/min/1.73 m2

3. Prior CCTA or invasive coronary angiography within the last 5 years

4. Any contraindications for CCTA

5. Previous use of statin or non-statin lipid-lowering medication (such as ezetimibe, PCSK9 inhibitor and XueZhiKang)

6. Life expectancy < 3 years

7. Other reasons the researcher deems inappropriate to attend

Related Conditions & MeSH terms

• Adherence, Medication
• Cardiovascular Risk Factors
• Primary Prevention
• Statin

Intervention

Diagnostic Test:
• Coronary Computed Tomography Angiography
Intervention strategies according to CCTA results

Other:
• Traditional cardiovascular risk stratification
Intervention strategies according to traditional cardiovascular risk stratification based on Chinese guidelines for lipid management (2023)

Locations

Country	Name	City	State
China	Research Institute Of Medical Imaging Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhang longjiang,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months	Taking lipid-lowering medication regularly defined as taking the established lipid-lowering medication (including statin, ezetimibe, xuezhikang and PCSK9 inhibitor) at least 24 days during the past 30 days.	12 months
Secondary	The proportion of participants achieving LDL-C targets at 12 months	The LDL-C treatment goals are made according to Chinese guideline	12 months
Secondary	The proportion of participants taking lipid-lowering medication regularly at 12 months.	The proportion of participants taking lipid-lowering medication regularly at 12 months. Taking lipid-lowering medication regularly defined as taking the established lipid-lowering medication (including statin, ezetimibe, xuezhikang and PCSK9 inhibitor) at least 24 days during the past 30 days.	12 months
Secondary	Cardiovascular events	Number of participants diagnosed with coronary heart disease, stroke (hemorrhagic and ischemic), TIA or cardiovascular death	12 months
Secondary	Prevalence of subclinical coronary atherosclerotic disease	Proportion of subjects with coronary atherosclerosis in participants who underwent coronary CTA scan (%)	baseline
Secondary	Lipid levels	including total cholesterol, LDL-C, HDL-C, triglycerides	12 months
Secondary	Hypertension control	SBP<140mmHg and DBP<90mmHg	12 months
Secondary	Diabetic control	HbA1c <53 mmol/mol (7.0%)	12 months
Secondary	Smoking cessation	Proportion of subjects who changed smoking habits (%)	12 months
Secondary	Exercise	Change in activity levels measured through international physical activity questionnaire	12 months
Secondary	Quality of life/Anxiety and Depression	Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)	12 months