Role of Coronary CTA on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population (RESPECT2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adherence, Medication; Primary Prevention; Cardiovascular Risk Factors; Statin
• Intervention / Treatment: Diagnostic test: Coronary Computed Tomography Angiography; Other: Traditional cardiovascular risk stratification

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 3400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Longjiang Zhang, MD; Phone Number: 13405833167; Email: kevinzhlj@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210018
      • Recruiting
      • Research Institute Of Medical Imaging Jinling Hospital
      • Contact: Longjiang Zhang, MD; Phone Number: 13405833176; Email: kevinzhlj@163.com
      • Contact: Xiang Guo, MD; Phone Number: 15820077389; Email: sdtzgx@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CCTA-based strategy group; Subjects will be managed following the CCTA -based coronary heart disease prevention strategy for lipid-lowering treatment and follow-up.	Diagnostic test: Coronary Computed Tomography Angiography; Intervention strategies according to CCTA results
Sham Comparator: Chinese guidelines for lipid management (2023); The baseline assessment will be completed on the same day as consent is gained. Every subjects will complete a comprehensive assessment including questionnaires and objective assessments.	Other: Traditional cardiovascular risk stratification; Intervention strategies according to traditional cardiovascular risk stratification based on Chinese guidelines for lipid management (2023)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of subclinical coronary atherosclerotic disease	Proportion of subjects with coronary atherosclerosis in participants who underwent coronary CTA scan (%)	baseline
Exercise	Change in activity levels measured through international physical activity questionnaire	12 months
Quality of life/Anxiety and Depression	Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)	12 months
Cardiovascular events	Number of participants diagnosed with coronary heart disease, stroke (hemorrhagic and ischemic), TIA or cardiovascular death	12 months
The proportion of participants achieving LDL-C targets at 12 months	The LDL-C treatment goals are made according to Chinese guideline	12 months
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
Hypertension control	SBP<140mmHg and DBP<90mmHg	12 months
Diabetic control	HbA1c <53 mmol/mol (7.0%)	12 months
Smoking cessation	Proportion of subjects who changed smoking habits (%)	12 months
LDL-C levels	Compare the difference in LDL-C concentration between baseline and one year later, with the measurement unit being mmol/L.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in renal function before and after CCTA examination	The status of kidney function is represented by eGFR.	All participants in the experimental group completed CCTA 1 month later

Collaborators and Investigators

• Sponsor: Zhang longjiang,MD
• Investigators: Study Chair: Trail Manager, Jinling Hospital,Nanjing University School of Medicine,Nanjing,China

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022DZKY-056-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No