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

Not Applicable

• Conditions: Coronary (Artery); Disease
• Interventions: Other: Myocardial Perfusion Scan; Other: Coronary CTA

• Registration Number: NCT03040700
• Lead Sponsor: Ministry of Health, Brazil

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-11
• Status Verified: 2017-01
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-31
• Last Update Submitted: 2017-01-31
• Study First Posted: 2017-02-02
• Last Update Posted: 2017-02-02
• Primary Completion: 2018-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myocardial Perfusion Scan	Myocardial Perfusion Scan	Myocardial perfusion stress test using cardiac scintigraphy (Sestamibi) at rest and during pharmacological stress (dipyridamole)
Coronary CTA	Coronary CTA	Coronary computed tomography angiography

Primary Outcome Measures

Name	Time	Method
Composite fatal/non-fatal MACE	5 years post-CABG	All-cause death, non-fatal MI, or myocardial revascularization

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	1, 3, and 5 years post-CABG	Death related to cardiovascular events including sudden death, and death due to acute coronary syndromes (unstable angina, myocardial infarction), heart failure, myocardial revascularization procedures
Cardiovascular hospitalizations	1, 3, and 5 years post-CABG	Hospital admissions due to cardiovascular events

Trial Locations

Locations (1)

Heart Institute; 🇧🇷 Sao Paulo, SP, Brazil