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

ConditionsStatin Cardiovascular Risk Factors Primary Prevention Adherence, Medication

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-69

SponsorZhang longjiang,MD

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Coronary Computed Tomography Angiography
Diagnostic test
Intervention strategies according to CCTA results
Traditional cardiovascular risk stratification
Other intervention
Intervention strategies according to traditional cardiovascular risk stratification based on Chinese guidelines for lipid management (2023)

Treatment groups

3,400 Participants

are divided into 2 treatment groups

Group A: CCTA-based strategy groupActive comparator 1 intervention

Group B: Chinese guidelines for lipid management (2023)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

12 months

Secondary outcomes

The proportion of participants achieving LDL-C targets at 12 months

The LDL-C treatment goals are made according to Chinese guideline

Time frame

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.

Time frame

12 months

Cardiovascular events

Number of participants diagnosed with coronary heart disease, stroke (hemorrhagic and ischemic), TIA or cardiovascular death

Time frame

12 months

Prevalence of subclinical coronary atherosclerotic disease

Proportion of subjects with coronary atherosclerosis in participants who underwent coronary CTA scan (%)

Time frame

baseline

Other outcomes

Changes in renal function before and after CCTA examination

The status of kidney function is represented by eGFR.

Time frame

All participants in the experimental group completed CCTA 1 month later

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhang longjiang,MD

Lead sponsor

Jinling Hospital, China

Sponsor institution

Source ClinicalTrials.gov

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