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Recruiting NCT05725096

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

No phase Interventional Statin Cardiovascular Risk Factors Primary Prevention Adherence, Medication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coronary Computed Tomography Angiography, Traditional cardiovascular risk stratification.
Who it may be relevant to
Registry conditions: Statin, Cardiovascular Risk Factors, Primary Prevention, Adherence, Medication. Basic parameters: 40 years — 69 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Interventions

  • 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)

Primary outcome measures

  • The proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months [Time frame: 12 months]
Secondary outcome measures (10)
  • The proportion of participants achieving LDL-C targets at 12 months [Time frame: 12 months]
  • The proportion of participants taking lipid-lowering medication regularly at 12 months. [Time frame: 12 months]
  • Cardiovascular events [Time frame: 12 months]
  • Prevalence of subclinical coronary atherosclerotic disease [Time frame: baseline]
  • LDL-C levels [Time frame: 12 months]
  • Hypertension control [Time frame: 12 months]
  • Diabetic control [Time frame: 12 months]
  • Smoking cessation [Time frame: 12 months]
  • Exercise [Time frame: 12 months]
  • Quality of life/Anxiety and Depression [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Nanjing residents who have no plans to leave in the next 5 years
  • Aged from 40 to 69 years
  • Free of any known clinically cardiovascular disease Able to comprehend and sign an informed consent form

Exclusion criteria

  • Serious liver dysfunction, defined as AST or ALT > 3 times the normal upper limit
  • Chronic kidney disease (CKD) > stage 4, defined as eGFR < 30 ml/min/1.73 m2
  • Prior CCTA or invasive coronary angiography within the last 5 years
  • Any contraindications for CCTA
  • Previous use of statin or non-statin lipid-lowering medication (such as ezetimibe, PCSK9 inhibitor and XueZhiKang)
  • Life expectancy < 3 years
  • Other reasons the researcher deems inappropriate to attend

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Research Institute Of Medical Imaging Jinling Hospital — Nanjing

Publications

  • Guo X, Li J, Zhu Y, Li Y, Jiang J, Zuo R, Xu W, Ma J, Li C, Yang J, Liu Y, Zhao M, Tian D, Wang X, Sun J, Wu B, Wang C, Jiang P, Zhang J, Zhong J, Zhou C, Yi D, Bao X, Cai J, Chen Y, Cheng X, Gong H, Wei Y, Liu Y, Zhang LJ. Role of the screening with coronary computed tomography angiography on lipid management and risk factors control in an asymptomatic Chinese population: a community-based, paral PMID 39350195

Identifiers

NCT: NCT05725096 · 2022DZKY-056-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗