Clinical trial NCT03040700: Follow-up of Patients With Multivessel Coronary Artery Disease After CABG
Official title: "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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary (Artery); Disease
Keywords: coronary artery disease
surgery
angina
myocardial ischemia
non-invasive testing
Lead sponsor: Ministry of Health, Brazil
Sponsor class: OTHER_GOV
First posted: 2017-02-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite fatal/non-fatal MACE
timeFrame: 5 years post-CABG
Secondary outcomes:
measure: Cardiovascular death
timeFrame: 1, 3, and 5 years post-CABG
measure: Cardiovascular hospitalizations
timeFrame: 1, 3, and 5 years post-CABG
Other outcomes:
measure: Angina functional class
timeFrame: 1, 3, and 5 years post-CABG
measure: Left ventricular function
timeFrame: 1, 3, and 5 years post-CABG
measure: Decline in renal function
timeFrame: 1, 3, and 5 years post-CABG
measure: Incidence of cancer
timeFrame: 1, 3, and 5 years post-CABG
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute
state: SP
Study officials:
affiliation: Heart Institute
name: Luis Henrique W Gowdak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: