跳至主要内容
临床试验/NCT03040700
NCT03040700Unknown不适用

"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"

Ministry of Health, Brazil1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

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

No Intervention

Regular medical visits every 6 months.

Myocardial Perfusion Scan

Experimental

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

Experimental

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

发起方
Ministry of Health, Brazil
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Luis Henrique W Gowdak, MD, PhD

Clinical Scientist

InCor Heart Institute

研究点 (1)

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