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

NCT03040700 | Unknown DMC

• 1 other identifier: 405153/2012-0
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary (Artery); Disease

Keywords

coronary artery disease; surgery; angina; myocardial ischemia; non-invasive testing

Outcome Measures

Primary Outcomes (1)

• Composite fatal/non-fatal MACE

  All-cause death, non-fatal MI, or myocardial revascularization

  5 years post-CABG

Secondary Outcomes (2)

• Cardiovascular death

  1, 3, and 5 years post-CABG

• Cardiovascular hospitalizations

  1, 3, and 5 years post-CABG

Other Outcomes (4)

• Angina functional class

  1, 3, and 5 years post-CABG

• Left ventricular function

  1, 3, and 5 years post-CABG

• Decline in renal function

  1, 3, and 5 years post-CABG

Study Arms (3)

Clinical

NO INTERVENTION

Regular medical visits every 6 months.

Myocardial Perfusion Scan

EXPERIMENTAL

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

Other: Myocardial Perfusion Scan

Coronary CTA

EXPERIMENTAL

Coronary computed tomography angiography

Other: Coronary CTA

Interventions

Myocardial Perfusion Scan OTHER

Myocardial perfusion scan will be performed at rest and during pharmacological stress with dipyridamole (99mTc-Sestamibi)

Myocardial Perfusion Scan

Coronary CTA OTHER

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.

Coronary CTA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented obstructive coronary artery disease

You may not qualify if:

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

Sponsors & Collaborators

• Ministry of Health, Brazil: lead

Study Sites (1)

Heart Institute

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis Henrique W Gowdak, MD, PhD

  Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priscila B Miagui, Pharma D

CONTACT

55-11-2661-5573; gestaodeprojetoslgcm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: February 2, 2017
• Study Start: November 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2021
• Last Updated: February 2, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)