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The primary objective of this study is to evaluate whether a management strategy based on coronary computed tomography angiography (CCTA) for patients with non-obstructive coronary artery disease can improve the LDL-C target achievement rate compared to a traditional management strategy without follow-up CCTA, thereby reducing the incidence of major adverse cardiovascular and cerebrovascular events over a 3 years period, including all-cause mortality, myocardial infarction, ischemia driven revascularation and stroke.
Patients with non-obstructive coronary artery disease have a high rate of adverse cardiovascular events, and currently, there is still a lack of effective management strategies for these patients in clinical practice. In the SUCCESS study, investigator will compare follow-up CCTA management with routine clinical management to assess the effectiveness of follow-up CCTA in improving lipid control and reducing cardiovascular events in these patients.
The SUCCESS study is a multicenter, randomized, parallel-controlled, interventional clinical trial that recruits patients with non-obstructive coronary artery disease identified on previous CCTA (coronary artery stenosis of 20% to 70% or left main coronary artery stenosis of 20% to 50%). The experimental group is the CCTA follow-up management group, and the control group is the routine clinical follow-up management group. All participants will be randomly assigned to the experimental and control groups in a 1:1 ratio. The experimental group will undergo management using follow-up CCTA, while the control group will be managed using routine clinical and laboratory examinations. At the 1-year follow-up, all participants will undergo laboratory re-examination to observe the impact of follow-up CCTA on lipid target achievement. After 3 years of follow-up, the differences in the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) between the two groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCTA-based follow-up management group | Active Comparator | The subjects will undergo routine clinical and laboratory examinations, as well as follow-up CCTA examinations to assess the progression of plaques and to recommend appropriate management, treatment, and follow-up based on the findings |
|
| clinical-based follow-up management group | Sham Comparator | The subjects will undergo routine clinical and laboratory examinations, and recommendations for appropriate management, treatment, and follow-up will be made based on the results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Computed Tomography Angiography | Diagnostic Test | Based on the assessment of plaque progression after follow-up CCTA examination, patients will be given either intensive treatment or routine treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular and cerebrovascular event | Record the number of participants experiencing major adverse cardiovascular and cerebrovascular event such as all-cause mortality, non-fatal myocardial infarction, ischemia driven revascularation and stroke | 36 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C control rate | The proportion of participants with controlled LDL-C(<1.4mmol/L) | 12 months after baseline |
| Mean LDL-C changes | Mean LDL-C changes of participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Longjiang Zhang, MD | Contact | 13405833167 | kevinzhlj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Trail Manager | Jinling Hospital,Nanjing University School of Medicine,Nanjing,China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute Of Medical Imaging Jinling Hospital | Recruiting | Nanjing | Jiangsu | 210018 | China |
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| Current clinical guidelines | Other | Patients will be treated according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes. |
|
| 12 months after baseline |
| Adherence to lipid-lowering medication rate | The proportion of participants who adhere to lipid-lowering drugs | 12 months after baseline |
| The difference in healthcare-seeking rates between the two groups | The difference in healthcare-seeking rates between the two groups of patients, including both regular follow-ups and visits driven by clinical symptoms of coronary heart disease | 12 months after baseline |
| Hypertension control rate | The proportion of participants with SBP<140mmHg and DBP<90mmHg. | 12 months after baseline |
| Diabetic control rate | The proportion of participants with HbA1c <53 mmol/mol (7.0%). | 12 months after baseline |
| Cardiac death | Number of participants diagnosed with cardiovascular death | 36 months after baseline |
| Fatal and non-fatal myocardial infarction or stroke | Number of participants diagnosed with myocardial infarction or stroke | 36 months after baseline |
| Rehospitalization due to progressive angina | Number of patients seeking medical care for unstable angina | 36 months after baseline |
| Major adverse cardiovascular event | Record the number of participants experiencing major adverse cardiovascular events such as all-cause mortality, non-fatal myocardial infarction and ischemia driven revascularation | 36 months after baseline |
| Procedures | The proportion of participants undergone procedures,including Invasive coronary angiography, percutaneous coronary intervention and coronary artery bypass graft surgery | 36 months after baseline |
| Radiation dose and incidental findings from CTCA | The total radiation dose received by the participants during multiple examinations after enrollment. | 36 months after baseline |
| Change in quality of life (SF-12) | Change in quality of life measured using 12-item Short-Form Health Survey Questionnaire (SF-12) instrument | 36 months after baseline |
| The primary outcome in different subgroups | The primary outcome (all-cause mortality, non-fatal myocardial infarction, ischemia driven revascularation and stroke) will be analyzed in prespecified subgroups, including age, sex, hypertension, diabetes mellitus, degree of stenosis on baseline CCTA. | 36 months after baseline |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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