Coronary (Artery); Disease
Conditions
Keywords
coronary artery disease, surgery, angina, myocardial ischemia, non-invasive testing
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.
Interventions
OTHERMyocardial Perfusion Scan
Myocardial perfusion scan will be performed at rest and during pharmacological stress with dipyridamole (99mTc-Sestamibi)
OTHERCoronary CTA
Coronary CTA will be performed using a 320-detector scanner, 0.5 mm slice thickness, with gantry rotation of 350ms. Prior to each scan, the patient's blood pressure and heart rate will be assessed, and if the heart rate is above 70bpm, beta-blockers will be given orally. Following oral beta blocker administration, if the heart rate is still greater than 64bpm, intravenous metoprolol will be administered. A total of 70-100 mL of iodinated contrast will be administered via an automated injector at a rate of 5mL/s. All coronary CTA images will be transferred to a workstation (Vitrea FX-Vital Image) and analyzed by two experienced cardiac imagers who are blinded to all other data using a standard 18-segment coronary tree model.
Sponsors
Ministry of Health, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite fatal/non-fatal MACE | 5 years post-CABG | All-cause death, non-fatal MI, or myocardial revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Angina functional class | 1, 3, and 5 years post-CABG | Canadian Cardiovascular Society classification of angina |
| Incidence of cancer | 1, 3, and 5 years post-CABG | Incidence of any, new diagnosed cancer |
| Left ventricular function | 1, 3, and 5 years post-CABG | LV ejection fraction assessed by echocardiography |
| Decline in renal function | 1, 3, and 5 years post-CABG | Assessment of the GFR by the MDRD Equation |
Countries
Brazil
Contacts
Primary ContactPriscila B Miagui, Pharma D
Outcome results
None listed