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

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ClinicalTrials.gov Identifier: NCT03040700
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Luis Henrique W Gowdak, MD, PhD, InCor Heart Institute

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.

Condition or disease Intervention/treatment Phase
Coronary (Artery); Disease Other: Myocardial Perfusion Scan Other: Coronary CTA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
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 Start Date : November 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Composite fatal/non-fatal MACE [ Time Frame: 5 years post-CABG ]
    All-cause death, non-fatal MI, or myocardial revascularization


Secondary Outcome Measures :
  1. Cardiovascular death [ Time Frame: 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

  2. Cardiovascular hospitalizations [ Time Frame: 1, 3, and 5 years post-CABG ]
    Hospital admissions due to cardiovascular events


Other Outcome Measures:
  1. Angina functional class [ Time Frame: 1, 3, and 5 years post-CABG ]
    Canadian Cardiovascular Society classification of angina

  2. Left ventricular function [ Time Frame: 1, 3, and 5 years post-CABG ]
    LV ejection fraction assessed by echocardiography

  3. Decline in renal function [ Time Frame: 1, 3, and 5 years post-CABG ]
    Assessment of the GFR by the MDRD Equation

  4. Incidence of cancer [ Time Frame: 1, 3, and 5 years post-CABG ]
    Incidence of any, new diagnosed cancer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040700


Contacts
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Contact: Priscila B Miagui, Pharma D 55-11-2661-5573 gestaodeprojetoslgcm@gmail.com

Locations
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Brazil
Heart Institute Recruiting
Sao Paulo, SP, Brazil, 05403-000
Contact: Luis Gowdak, MD, PhD    551126615929    luis.gowdak@incor.usp.br   
Principal Investigator: Luis Henrique W Gowdak, MD, PhD         
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         
Sponsors and Collaborators
Ministry of Health, Brazil
Investigators
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Principal Investigator: Luis Henrique W Gowdak, MD, PhD Heart Institute
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Responsible Party: Luis Henrique W Gowdak, MD, PhD, Clinical Scientist, InCor Heart Institute
ClinicalTrials.gov Identifier: NCT03040700    
Other Study ID Numbers: 405153/2012-0
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Luis Henrique W Gowdak, MD, PhD, InCor Heart Institute:
coronary artery disease
surgery
angina
myocardial ischemia
non-invasive testing
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases