<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03040700</url>
  </required_header>
  <id_info>
    <org_study_id>405153/2012-0</org_study_id>
    <nct_id>NCT03040700</nct_id>
  </id_info>
  <brief_title>Follow-up of Patients With Multivessel Coronary Artery Disease After CABG</brief_title>
  <acronym>FAMOUS</acronym>
  <official_title>&quot;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&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministry of Health, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ministry of Health, Brazil</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The FAMOUS Trial is a single-center, prospective, randomized study aimed to compare three&#xD;
      different strategies (clinical, anatomical, or functional) in preventing MACE after CABG. A&#xD;
      total of 600 patients will be included and followed for 5 years. Patients will be randomly&#xD;
      allocated (1:1:1) in one of the three follow-up strategies. Patients in the clinical arm will&#xD;
      be followed by regular medical visits only every 6 months; patients in the functional arm&#xD;
      will undergo a myocardial perfusion scan, and those in the anatomical arm will be subjected&#xD;
      to a coronary CT. Non-invasive tests will be performed per protocol and regardless symptoms&#xD;
      every 2 years after the first year post-surgery. The primary outcome will be the incidence of&#xD;
      death, acute myocardial infarction or myocardial revascularization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Coronary artery disease (CAD) is a highly prevalent clinical condition, usually&#xD;
      associated with impairment in quality of life, and with a high risk for cardiovascular events&#xD;
      including myocardial infarction and cardiovascular death. Because of the anatomical and/or&#xD;
      functional extension of the disease, combined with high-risk clinical features (left&#xD;
      ventricular dysfunction, diabetes, or chronic kidney disease to name a few), many patients&#xD;
      must undergo a coronary artery bypass grafting (CABG) surgery. In the USA, 400,000 CABG&#xD;
      surgeries are performed annually.&#xD;
&#xD;
      Although the benefits of CABG for those high-risk patients have been well established in the&#xD;
      long-term, the best follow-up strategy after surgery is still controversial. Current&#xD;
      guidelines generally recommend that the follow-up of patients after CABG should be based on&#xD;
      the same strategies proposed for patients with stable angina. The investigators hypothesized&#xD;
      that the early identification of myocardial ischemia or progression of coronary&#xD;
      atherosclerosis, even in asymptomatic patients, may be superior to clinical follow-up alone&#xD;
      for the prevention of cardiovascular events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite fatal/non-fatal MACE</measure>
    <time_frame>5 years post-CABG</time_frame>
    <description>All-cause death, non-fatal MI, or myocardial revascularization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>1, 3, and 5 years post-CABG</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular hospitalizations</measure>
    <time_frame>1, 3, and 5 years post-CABG</time_frame>
    <description>Hospital admissions due to cardiovascular events</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Angina functional class</measure>
    <time_frame>1, 3, and 5 years post-CABG</time_frame>
    <description>Canadian Cardiovascular Society classification of angina</description>
  </other_outcome>
  <other_outcome>
    <measure>Left ventricular function</measure>
    <time_frame>1, 3, and 5 years post-CABG</time_frame>
    <description>LV ejection fraction assessed by echocardiography</description>
  </other_outcome>
  <other_outcome>
    <measure>Decline in renal function</measure>
    <time_frame>1, 3, and 5 years post-CABG</time_frame>
    <description>Assessment of the GFR by the MDRD Equation</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of cancer</measure>
    <time_frame>1, 3, and 5 years post-CABG</time_frame>
    <description>Incidence of any, new diagnosed cancer</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Coronary (Artery); Disease</condition>
  <arm_group>
    <arm_group_label>Clinical</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Regular medical visits every 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Myocardial Perfusion Scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Myocardial perfusion stress test using cardiac scintigraphy (Sestamibi) at rest and during pharmacological stress (dipyridamole)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Coronary CTA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coronary computed tomography angiography</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myocardial Perfusion Scan</intervention_name>
    <description>Myocardial perfusion scan will be performed at rest and during pharmacological stress with dipyridamole (99mTc-Sestamibi)</description>
    <arm_group_label>Myocardial Perfusion Scan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Coronary CTA</intervention_name>
    <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.</description>
    <arm_group_label>Coronary CTA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented obstructive coronary artery disease&#xD;
&#xD;
          -  Isolated, recent CABG (&lt; 30 days from inclusion)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant, severe heart disease from other etiologies including valvular heart&#xD;
             disease, advanced dilated cardiomyopathy, etc&#xD;
&#xD;
          -  Glomerular filtration rate &lt; 30mL/min/1.73m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis Henrique W Gowdak, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Priscila B Miagui, Pharma D</last_name>
    <phone>55-11-2661-5573</phone>
    <email>gestaodeprojetoslgcm@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Heart Institute</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Gowdak, MD, PhD</last_name>
      <phone>551126615929</phone>
      <email>luis.gowdak@incor.usp.br</email>
    </contact>
    <investigator>
      <last_name>Luis Henrique W Gowdak, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>José Eduardo Krieger, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luiz Antônio M César, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carlos Eduardo Rochitte, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>José Cláudio Meneghetti, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giuliano S Ciambelli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gustavo T Queiroz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Leonardo Luis T Bianchi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>InCor Heart Institute</investigator_affiliation>
    <investigator_full_name>Luis Henrique W Gowdak, MD, PhD</investigator_full_name>
    <investigator_title>Clinical Scientist</investigator_title>
  </responsible_party>
  <keyword>coronary artery disease</keyword>
  <keyword>surgery</keyword>
  <keyword>angina</keyword>
  <keyword>myocardial ischemia</keyword>
  <keyword>non-invasive testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03040700
org study id: 405153/2012-0
nct id: NCT03040700
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
measure: Composite fatal/non-fatal MACE
time frame: 5 years post-CABG
description: All-cause death, non-fatal MI, or myocardial revascularization
measure: Cardiovascular death
time frame: 1, 3, and 5 years post-CABG
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
measure: Cardiovascular hospitalizations
time frame: 1, 3, and 5 years post-CABG
description: Hospital admissions due to cardiovascular events
measure: Angina functional class
time frame: 1, 3, and 5 years post-CABG
description: Canadian Cardiovascular Society classification of angina
measure: Left ventricular function
time frame: 1, 3, and 5 years post-CABG
description: LV ejection fraction assessed by echocardiography
measure: Decline in renal function
time frame: 1, 3, and 5 years post-CABG
description: Assessment of the GFR by the MDRD Equation
measure: Incidence of cancer
time frame: 1, 3, and 5 years post-CABG
description: Incidence of any, new diagnosed cancer
arm group label: Clinical
arm group type: No Intervention
description: Regular medical visits every 6 months.
arm group label: Myocardial Perfusion Scan
arm group type: Experimental
description: Myocardial perfusion stress test using cardiac scintigraphy (Sestamibi) at rest and during pharmacological stress (dipyridamole)
arm group label: Coronary CTA
arm group type: Experimental
description: Coronary computed tomography angiography
intervention type: Other
intervention name: Myocardial Perfusion Scan
description: Myocardial perfusion scan will be performed at rest and during pharmacological stress with dipyridamole (99mTc-Sestamibi)
arm group label: Myocardial Perfusion Scan
intervention type: Other
intervention name: Coronary CTA
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.
arm group label: Coronary CTA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Luis Henrique W Gowdak, MD, PhD
role: Principal Investigator
affiliation: Heart Institute
last name: Priscila B Miagui, Pharma D
phone: 55-11-2661-5573
email: gestaodeprojetoslgcm@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: InCor Heart Institute
investigator full name: Luis Henrique W Gowdak, MD, PhD
investigator title: Clinical Scientist
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No