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NCT Number: NCT05725096

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

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.

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Key information

Conditions

Statin Adherence, Medication Behavior Cardiovascular Risk Factors Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Primary Prevention Treatment Adherence and Compliance

Age range

40 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary Computed Tomography Angiography

Diagnostic Test

Intervention strategies according to CCTA results

Traditional cardiovascular risk stratification

Other

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

Primary outcomes

  1. The proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months

    Time frame: 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.

Secondary outcomes

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

    Time frame: 12 months

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

  2. The proportion of participants taking lipid-lowering medication regularly at 12 months.

    Time frame: 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.

  3. Cardiovascular events

    Time frame: 12 months

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

  4. Prevalence of subclinical coronary atherosclerotic disease

    Time frame: baseline

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

  5. LDL-C levels

    Time frame: 12 months

    Compare the difference in LDL-C concentration between baseline and one year later, with the measurement unit being mmol/L.

  6. Hypertension control

    Time frame: 12 months

    SBP<140mmHg and DBP<90mmHg

  7. Diabetic control

    Time frame: 12 months

    HbA1c <53 mmol/mol (7.0%)

  8. Smoking cessation

    Time frame: 12 months

    Proportion of subjects who changed smoking habits (%)

  9. Exercise

    Time frame: 12 months

    Change in activity levels measured through international physical activity questionnaire

  10. Quality of life/Anxiety and Depression

    Time frame: 12 months

    Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)

Other outcomes

  1. Changes in renal function before and after CCTA examination

    Time frame: All participants in the experimental group completed CCTA 1 month later

    The status of kidney function is represented by eGFR.

Study contacts

Contact information is provided by the study sponsor or research team.

Longjiang Zhang, MD

CONTACT

[email protected]

13405833167

Sponsors and collaborators

Lead sponsor

Zhang longjiang,MD

Other

Registry information

Official study 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

Acronym: RESPECT2

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Feb 13, 2023
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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