Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,100
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular and cerebrovascular event
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years old;
- •Known patients with non-obstructive coronary artery disease (disease duration ≥2 years);
- •Patients who agree to undergo follow-up CCTA examinations and cooperate in completing follow-up observations.
排除标准
- •Patients who have experienced ACS or PCI/CABG;
- •Patients who have experienced adverse cardiovascular and cerebrovascular events;
- •Patients who have undergone follow-up CCTA or DSA examinations before enrollment;
- •Patients with severe hepatic and renal dysfunction;
- •Patients with contraindications to CCTA examinations;
- •Patients with poor initial CCTA image quality or data loss.
研究组 & 干预措施
CCTA-based follow-up management group
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
干预措施: Coronary Computed Tomography Angiography (Diagnostic Test)
clinical-based follow-up management group
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.
干预措施: Current clinical guidelines (Other)
结局指标
主要结局
Major adverse cardiovascular and cerebrovascular event
时间窗: 36 months after baseline
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
次要结局
- Hypertension control rate(12 months after baseline)
- Rehospitalization due to progressive angina(36 months after baseline)
- Fatal and non-fatal myocardial infarction or stroke(36 months after baseline)
- LDL-C control rate(12 months after baseline)
- Mean LDL-C changes(12 months after baseline)
- Adherence to lipid-lowering medication rate(12 months after baseline)
- The difference in healthcare-seeking rates between the two groups(12 months after baseline)
- Diabetic control rate(12 months after baseline)
- Cardiac death(36 months after baseline)
- Major adverse cardiovascular event(36 months after baseline)
- Procedures(36 months after baseline)
- Radiation dose and incidental findings from CTCA(36 months after baseline)
- Change in quality of life (SF-12)(36 months after baseline)
- The primary outcome in different subgroups(36 months after baseline)
研究者
Zhang longjiang,MD
Principal Investigator : Zhang longjiang
Jinling Hospital, China