A Randomized, Controlled Trial in Patients With Suspected Coronary Artery Disease Based on Acute or Chronic Atypical Angina Pectoris - EXTEND
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Comparison of coronary plaque burden (non-calcified plaque volume (NCPV) measured by CT at 10-years between the initial randomization CT and ICA groups
研究概览
简要总结
CAD-Man Extend is the long-term follow-up (clinical, laboratory, and computed tomography (CT) imaging) of a single-center, randomized, controlled CAD-Man trial comparing a CT-first strategy with a direct- invasive coronary angiography (ICA) diagnostic and management strategy, in 329 patients clinically referred for ICA with atypical angina or chest pain.
Overall goal:
The extension of CAD-Man follow-up (clinical, laboratory, and CT imaging) to approximately 10 years will provide the opportunity to compare plaque burden with CT-guided management versus direct-ICA at long-term and other endpoints.
详细描述
The CAD-Man (Coronary Artery Disease Management with Multislice Computed Tomography and Magnetic Resonance Imaging in Patients with Atypical Angina Pectoris) trial evaluated whether computed tomography (CT) or invasive coronary angiography (ICA) should be performed in patients clinically referred for coronary angiography with an intermediate probability of coronary artery disease. Patients with suspected CAD were randomized 1:1 ratio to CT, followed by ICA if positive for obstructive CAD, or to direct ICA. In both tests, obstructive CAD was defined as at least a 50% diameter stenosis in the left main coronary artery or at least a 70% diameter stenosis in other coronary arteries. Investigators and participants were blinded to randomization sequence but could not be blinded to the assigned group because of the apparent differences between CT and ICA. Independent investigators, who were blinded to the randomization group and were not part of the study team, anonymously assessed outcomes. Results on the comparative effectiveness of CT and ICA in preventing the primary outcome of major procedural complications within 48 hours of the last procedure and major adverse events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) were published for a median follow-up of 3.3 years.
The primary results and additional subgroup analyses of the CAD-Man trial led to three new hypotheses that will be evaluated in the CAD-Man Extend study.
- Main hypothesis:
Whether CT-guided management of patients with atypical angina results in a reduction in coronary plaque burden (as determined by repeat CT scan) compared with direct-ICA management until 10 years. 2. Secondary hypothesis:
1. Whether clinical characteristics or blood levels and lipid-lowering medications have an impact on intraindividual progression of coronary plaques in patients in the CT group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected CAD
- •Patients with atypical angina
- •Patients who have previously participated in the CAD-Man study and have not died at a median follow-up of 3.3 years.
排除标准
- •Exclusion criteria for additional CT scan:
- •Pregnancy
- •Any health condition that would cause concern that participation would not be in the best interest of health (eg, extensive comorbidities)
结局指标
主要结局
Comparison of coronary plaque burden (non-calcified plaque volume (NCPV) measured by CT at 10-years between the initial randomization CT and ICA groups
时间窗: at 10 years
Comparison of coronary plaque burden total plaque volume (TPV)) measured by CT at 10-years between CT and ICA groups
时间窗: at 10 years
次要结局
- Comparison of the difference in chronic kidney injury, (eGFR and as increase in creatinine by 25% or 0.5 mg/dl) in both groups at 10-year follow-up between CT and ICA groups.(at 10 years)
- Intraindividual progression of coronary artery disease (defined as change in coronary plaque burden from the first CT until the CT examination after 10 years) in the CT group.(at 10 years)
研究者
Marc Dewey
Prof. Dr. Dr. h.c. Marc Dewey
Charite University, Berlin, Germany