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

"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"

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.

Study Overview

• Status: Unknown
• Conditions: Coronary (Artery); Disease
• Intervention / Treatment: Other: Myocardial Perfusion Scan; Other: Coronary CTA

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403-000
      • Recruiting
      • Heart Institute
      • Principal Investigator: Luis Henrique W Gowdak, MD, PhD
      • Contact: Luis Gowdak, MD, PhD; Phone Number: 551126615929; Email: luis.gowdak@incor.usp.br
      • Principal Investigator: José Eduardo Krieger, MD, PhD
      • Principal Investigator: Luiz Antônio M César, MD, PhD
      • Sub-Investigator: Carlos Eduardo Rochitte, MD, PhD
      • Sub-Investigator: José Cláudio Meneghetti, MD, PhD
      • Sub-Investigator: Giuliano S Ciambelli, MD
      • Sub-Investigator: Gustavo T Queiroz, MD
      • Sub-Investigator: Leonardo Luis T Bianchi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Clinical; Regular medical visits every 6 months.
Experimental: Myocardial Perfusion Scan; Myocardial perfusion stress test using cardiac scintigraphy (Sestamibi) at rest and during pharmacological stress (dipyridamole)	Other: Myocardial Perfusion Scan; Myocardial perfusion scan will be performed at rest and during pharmacological stress with dipyridamole (99mTc-Sestamibi)
Experimental: Coronary CTA; Coronary computed tomography angiography	Other: Coronary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite fatal/non-fatal MACE	All-cause death, non-fatal MI, or myocardial revascularization	5 years post-CABG

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angina functional class	Canadian Cardiovascular Society classification of angina	1, 3, and 5 years post-CABG
Left ventricular function	LV ejection fraction assessed by echocardiography	1, 3, and 5 years post-CABG
Decline in renal function	Assessment of the GFR by the MDRD Equation	1, 3, and 5 years post-CABG
Incidence of cancer	Incidence of any, new diagnosed cancer	1, 3, and 5 years post-CABG

Collaborators and Investigators

• Sponsor: Ministry of Health, Brazil
• Investigators: Principal Investigator: Luis Henrique W Gowdak, MD, PhD, Heart Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: surgery; coronary artery disease; angina; myocardial ischemia; non-invasive testing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 405153/2012-0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO