Actively Recruiting

Phase Not Applicable
Age: 40Years - 69Years
All Genders
ID05725096

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

Led by Zhang longjiang,MD · Updated on 2024-11-26

3400

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether a heart disease prevention approach using coronary computed tomography angiography (CCTA) can improve the management of cholesterol-lowering treatments and control of cardiovascular risk factors compared to the traditional method based on cardiovascular risk scores. This study focuses on an asymptomatic Chinese population aged 40 to 69 years without known cardiovascular events. It aims to better understand the impact of CCTA screening on personalized prevention strategies and the prevalence of hidden coronary artery disease. Participants will be randomly assigned to one of two groups: one receiving prevention programs guided by CCTA results, and the other managed using traditional cardiovascular risk scores based on Chinese guidelines for lipid management. The study will include baseline assessments with questionnaires and objective evaluations on the same day as consent. Both groups will follow their respective prevention strategies, with lipid-lowering treatment and risk factor control monitored over time. During the 12 months of follow-up, researchers will assess how many participants regularly take lipid-lowering medications and achieve LDL cholesterol targets, as well as monitor cardiovascular events, blood pressure, diabetes control, smoking cessation, exercise habits, and quality of life measures including anxiety and depression. The study will also report on the prevalence of subclinical coronary atherosclerosis detected by CCTA at baseline. The overall participation involves regular assessments to evaluate the effectiveness of the prevention strategies over one year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline

Participants undergo coronary computed tomography angiography (CCTA) or traditional cardiovascular risk stratification to guide individualized primary prevention programs for coronary heart disease.

1 baseline visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants are monitored for lipid-lowering treatment adherence and cardiovascular risk factor control over 12 months.

Follow-up visits to assess treatment adherence and risk factor control

Trial Site Locations

Total: 1 location

1

Research Institute Of Medical Imaging Jinling Hospital

Nanjing, Jiangsu, China, 210018

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Research Team

L

Longjiang Zhang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Role of the screening with coronary computed tomography angiography on lipid management and risk factors control in an asymptomatic Chinese population: a community-based, parallel-group, open-label, randomized clinical trial (RESPECT2).

Xiang Guo, Jianhua Li, Ying Zhu...

https://pubmed.ncbi.nlm.nih.gov/39350195