RESPECT-2: Effect of the RESPECT Trial on Lipid-lowering Treatment Adherence
Study Details
Study Description
Brief Summary
This is a pilot-study of the Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease (RESPECT [NCT05431309]) 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 adherence and risk factor control compared with traditional CHD prevention strategy, guided by a cardiovascular risk score.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 adherence and risk factor control.
This study will recruit 3000 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 adherence and 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CCTA-based strategy group 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
Intervention strategies were selected according to CCTA results
|
| Sham Comparator: China-PAR Score only 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: No Intervention
China-PAR score
|
Outcome Measures
Primary Outcome Measures
- Self-reported current use of lipid-lowering treatment [12 months]
Self-reported current use of lipid-lowering treatment (including statin and nonstatin drugs, such as ezetimibe, PCSK9 inhibitor, Xuezhikang,etc) according to physician's recommendation (%)
Secondary Outcome Measures
- Prevalence of subclinical coronary atherosclerotic disease [baseline]
Proportion of subjects with coronary atherosclerosis in participants who underwent coronary CTA scan (%)
- Tracking atherosclerosis over time [baseline and 12 months later]
Changes in the degree of coronary artery stenosis will be observed by coronary CTA in participants with coronary atherosclerosis
- Cardiovascular events [12 months]
Number of participants diagnosed with coronary heart disease, stroke (hemorrhagic and ischemic), TIA or cardiovascular death
- lipid-lowering therapies adherence [3 months, 6 months, 9 months]
including statin and nonstatin drugs, such as ezetimibe, PCSK9 inhibitor, Xuezhikang,etc
- Lipid levels [3 months, 6 months, 9 months, 12 months]
including total cholesterol, LDL-C, HDL-C, triglycerides
- Hypertension control [3 months, 6 months, 9 months, 12 months]
SBP<140mmHg and DBP<90mmHg
- Diabetic control [3 months, 6 months, 9 months, 12 months]
HbA1c <53 mmol/mol (7.0%)
- China-PAR score [baseline and 12 months later]
A Ten-year CVD risk model, prediction for ASCVD Risk (nonfatal myocardial infarction, fatal or nonfatal stroke, and CVD death) in China, as recommended in the Chinese CVD prevention guidelines. Low, medium, high risk was defined as a predicted 10-year CVD risk <5%, 5%~9.9% and ≥10%, respectively.
- Smoking cessation [3 months, 6 months, 9 months, 12 months]
Proportion of subjects who changed smoking habits (%)
- Exercise [12 months]
Change in activity levels measured through international physical activity questionnaire
- Quality of life/Anxiety and Depression [12 months]
Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)
Eligibility Criteria
Criteria
Inclusion Criteria:
- 1.Resident population aged 40-69 in Nanjing, China
Exclusion Criteria:
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1.Plan to leave Nanjing within 5 years or be unable to complete the follow-up work
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2.Refuse to sign informed consent
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3.Known atherosclerotic cardiovascular disease (eg. angina, coronary heart disease, stroke, transient ischemic attack, peripheral vascular disease)
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4.Serious chronic kidney disease (eGFR< 30 ml/min/1.73 m2)
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5.Serious liver disease or dysfunction (chronic active hepatitis and cirrhosis, or aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal)
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6.Prior coronary computed tomography angiography or invasive coronary angiography within the last 5 years
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7.Not appropriate to be tested due to birth planning, allergies, acute thyroid storm, etc
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8.Current use of lipid-lowering treatment (including statin and nonstatin drugs, such as ezetimibe, PCSK9 inhibitor, Xuezhikang,etc)
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9.Patients with diseases that seriously affect the survival period, such as malignant tumors
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10.Other conditions at the discretion of the research group
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Institute Of Medical Imaging Jinling Hospital | Nanjing | Jiangsu | China | 210018 |
Sponsors and Collaborators
- Zhang longjiang,MD
Investigators
- Study Chair: Trail Manager, Jinling Hospital,Nanjing University School of Medicine,Nanjing,China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022DZKY-056-01