"Long-term Follow-up of Patients With Multivessel Coronary Artery Disease Undergoing CABG - Comparison Between Functional, Anatomical, or Medical Only-Based Evaluation to Prevent Cardiovascular Events - The FAMOUS Trial"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Composite fatal/non-fatal MACE
研究概览
简要总结
The FAMOUS Trial is a single-center, prospective, randomized study aimed to compare three different strategies (clinical, anatomical, or functional) in preventing MACE after CABG. A total of 600 patients will be included and followed for 5 years. Patients will be randomly allocated (1:1:1) in one of the three follow-up strategies. Patients in the clinical arm will be followed by regular medical visits only every 6 months; patients in the functional arm will undergo a myocardial perfusion scan, and those in the anatomical arm will be subjected to a coronary CT. Non-invasive tests will be performed per protocol and regardless symptoms every 2 years after the first year post-surgery. The primary outcome will be the incidence of death, acute myocardial infarction or myocardial revascularization.
详细描述
Background: Coronary artery disease (CAD) is a highly prevalent clinical condition, usually associated with impairment in quality of life, and with a high risk for cardiovascular events including myocardial infarction and cardiovascular death. Because of the anatomical and/or functional extension of the disease, combined with high-risk clinical features (left ventricular dysfunction, diabetes, or chronic kidney disease to name a few), many patients must undergo a coronary artery bypass grafting (CABG) surgery. In the USA, 400,000 CABG surgeries are performed annually.
Although the benefits of CABG for those high-risk patients have been well established in the long-term, the best follow-up strategy after surgery is still controversial. Current guidelines generally recommend that the follow-up of patients after CABG should be based on the same strategies proposed for patients with stable angina. The investigators hypothesized that the early identification of myocardial ischemia or progression of coronary atherosclerosis, even in asymptomatic patients, may be superior to clinical follow-up alone for the prevention of cardiovascular events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Documented obstructive coronary artery disease
- •Isolated, recent CABG (< 30 days from inclusion)
排除标准
- •Concomitant, severe heart disease from other etiologies including valvular heart disease, advanced dilated cardiomyopathy, etc
- •Glomerular filtration rate < 30mL/min/1.73m2
研究组 & 干预措施
Clinical
Regular medical visits every 6 months.
Myocardial Perfusion Scan
Myocardial perfusion stress test using cardiac scintigraphy (Sestamibi) at rest and during pharmacological stress (dipyridamole)
干预措施: Myocardial Perfusion Scan (Other)
Coronary CTA
Coronary computed tomography angiography
干预措施: Coronary CTA (Other)
结局指标
主要结局
Composite fatal/non-fatal MACE
时间窗: 5 years post-CABG
All-cause death, non-fatal MI, or myocardial revascularization
次要结局
- Cardiovascular death(1, 3, and 5 years post-CABG)
- Cardiovascular hospitalizations(1, 3, and 5 years post-CABG)
研究者
Luis Henrique W Gowdak, MD, PhD
Clinical Scientist
InCor Heart Institute
