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

NCT05725096 | Recruiting DMC

• 1 other identifier: 2022DZKY-056-01
• Study Type: interventional
• Target: 3,400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Statin; Cardiovascular Risk Factors; Primary Prevention; Adherence, Medication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

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

  12 months

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

  12 months

• Cardiovascular events

  12 months

• Prevalence of subclinical coronary atherosclerotic disease

  baseline

• LDL-C levels

  12 months

Other Outcomes (1)

• Changes in renal function before and after CCTA examination

  All participants in the experimental group completed CCTA 1 month later

Study Arms (2)

CCTA-based strategy group

ACTIVE COMPARATOR

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

Chinese guidelines for lipid management (2023)

SHAM COMPARATOR

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

Interventions

Coronary Computed Tomography Angiography DIAGNOSTIC_TEST

Intervention strategies according to CCTA results

CCTA-based strategy group

Traditional cardiovascular risk stratification OTHER

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

Chinese guidelines for lipid management (2023)

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhang longjiang,MD: lead

Study Sites (1)

Research Institute Of Medical Imaging Jinling Hospital

Nanjing, Jiangsu, 210018, China

RECRUITING

Related Publications (1)

• 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, parallel-group, open-label, randomized clinical trial (RESPECT2). Trials. 2024 Sep 30;25(1):635. doi: 10.1186/s13063-024-08469-z.

  PMID: 39350195 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Trail Manager

  Jinling Hospital,Nanjing University School of Medicine,Nanjing,China

  STUDY CHAIR

Central Study Contacts

Longjiang Zhang, MD

CONTACT

13405833167; kevinzhlj@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator : Zhang longjiang

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: June 28, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

CN (1)