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

Primary Purpose

Coronary (Artery); Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Myocardial Perfusion Scan
Coronary CTA
Sponsored by
Ministry of Health, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Coronary (Artery); Disease focused on measuring coronary artery disease, surgery, angina, myocardial ischemia, non-invasive testing

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Clinical

Myocardial Perfusion Scan

Coronary CTA

Arm Description

Regular medical visits every 6 months.

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

Coronary computed tomography angiography

Outcomes

Primary Outcome Measures

Composite fatal/non-fatal MACE
All-cause death, non-fatal MI, or myocardial revascularization

Secondary Outcome Measures

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
Cardiovascular hospitalizations
Hospital admissions due to cardiovascular events

Full Information

First Posted
January 6, 2017
Last Updated
January 31, 2017
Sponsor
Ministry of Health, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT03040700
Brief Title
Follow-up of Patients With Multivessel Coronary Artery Disease After CABG
Acronym
FAMOUS
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary (Artery); Disease
Keywords
coronary artery disease, surgery, angina, myocardial ischemia, non-invasive testing

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical
Arm Type
No Intervention
Arm Description
Regular medical visits every 6 months.
Arm Title
Myocardial Perfusion Scan
Arm Type
Experimental
Arm Description
Myocardial perfusion stress test using cardiac scintigraphy (Sestamibi) at rest and during pharmacological stress (dipyridamole)
Arm Title
Coronary CTA
Arm Type
Experimental
Arm Description
Coronary computed tomography angiography
Intervention Type
Other
Intervention Name(s)
Myocardial Perfusion Scan
Intervention Description
Myocardial perfusion scan will be performed at rest and during pharmacological stress with dipyridamole (99mTc-Sestamibi)
Intervention Type
Other
Intervention Name(s)
Coronary CTA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite fatal/non-fatal MACE
Description
All-cause death, non-fatal MI, or myocardial revascularization
Time Frame
5 years post-CABG
Secondary Outcome Measure Information:
Title
Cardiovascular death
Description
Death related to cardiovascular events including sudden death, and death due to acute coronary syndromes (unstable angina, myocardial infarction), heart failure, myocardial revascularization procedures
Time Frame
1, 3, and 5 years post-CABG
Title
Cardiovascular hospitalizations
Description
Hospital admissions due to cardiovascular events
Time Frame
1, 3, and 5 years post-CABG
Other Pre-specified Outcome Measures:
Title
Angina functional class
Description
Canadian Cardiovascular Society classification of angina
Time Frame
1, 3, and 5 years post-CABG
Title
Left ventricular function
Description
LV ejection fraction assessed by echocardiography
Time Frame
1, 3, and 5 years post-CABG
Title
Decline in renal function
Description
Assessment of the GFR by the MDRD Equation
Time Frame
1, 3, and 5 years post-CABG
Title
Incidence of cancer
Description
Incidence of any, new diagnosed cancer
Time Frame
1, 3, and 5 years post-CABG

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priscila B Miagui, Pharma D
Phone
55-11-2661-5573
Email
gestaodeprojetoslgcm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Henrique W Gowdak, MD, PhD
Organizational Affiliation
Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Gowdak, MD, PhD
Phone
551126615929
Email
luis.gowdak@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Luis Henrique W Gowdak, MD, PhD
First Name & Middle Initial & Last Name & Degree
José Eduardo Krieger, MD, PhD
First Name & Middle Initial & Last Name & Degree
Luiz Antônio M César, MD, PhD
First Name & Middle Initial & Last Name & Degree
Carlos Eduardo Rochitte, MD, PhD
First Name & Middle Initial & Last Name & Degree
José Cláudio Meneghetti, MD, PhD
First Name & Middle Initial & Last Name & Degree
Giuliano S Ciambelli, MD
First Name & Middle Initial & Last Name & Degree
Gustavo T Queiroz, MD
First Name & Middle Initial & Last Name & Degree
Leonardo Luis T Bianchi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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