Follow-up of Patients With Multivessel Coronary Artery Disease After CABG (FAMOUS)

Ministry of Health, Brazil

Status: Unknown

Conditions: Coronary (Artery); Disease

Treatments: Other: Coronary CTA; Other: Myocardial Perfusion Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT03040700

405153/2012-0

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented obstructive coronary artery disease
• Isolated, recent CABG (< 30 days from inclusion)

Exclusion criteria

• Concomitant, severe heart disease from other etiologies including valvular heart disease, advanced dilated cardiomyopathy, etc
• Glomerular filtration rate < 30mL/min/1.73m2

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 3 patient groups

Clinical

No Intervention group

Description:

Regular medical visits every 6 months.

Myocardial Perfusion Scan

Experimental group

Description:

Myocardial perfusion stress test using cardiac scintigraphy (Sestamibi) at rest and during pharmacological stress (dipyridamole)

Treatment:

Other: Myocardial Perfusion Scan

Coronary CTA

Experimental group

Description:

Coronary computed tomography angiography

Treatment:

Other: Coronary CTA