<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/NCT01727063</url>
  </required_header>
  <id_info>
    <org_study_id>EMRTCC-ISQ2</org_study_id>
    <nct_id>NCT01727063</nct_id>
  </id_info>
  <brief_title>Cell Therapy in Severe Chronic Ischemic Heart Disease</brief_title>
  <acronym>MiHeart</acronym>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery</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>
      Patients with advanced coronary artery disease usually undergo incomplete myocardial&#xD;
      revascularization due to the extension and diffuseness of the disease, with very poor distal&#xD;
      arterial beds unsuitable for direct revascularization.&#xD;
&#xD;
      This study was designed to test the hypothesis that direct, intramyocardial injection of&#xD;
      autologous bone marrow cells may further improve myocardial perfusion in patients undergoing&#xD;
      incomplete bypass surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously&#xD;
      identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be&#xD;
      randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived&#xD;
      cells (BMC) during surgery.&#xD;
&#xD;
      During follow-up, myocardial perfusion assessment will be performed to determine the&#xD;
      improvement in treated areas compared to non-treated segments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2006</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Intramyocardial injection of bone marrow-derived cells OR placebo (saline) during CABG</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase in myocardial perfusion</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>Patients will undergo myocardial perfusion assessment by MRI during pharmacological stress with adenosine or dipyridamole. Alternatively, cardiac scintigraphy can be used in patients with contra-indications to MRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in LV function</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>LV function (global and regional) will be assessed by MRI.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Improvement in angina functional class</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>Angina functional class will be determined using the Canadian Cardiovascular Society classification.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">143</enrollment>
  <condition>Chronic Ischemic Heart Disease</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Angina Pectoris</condition>
  <arm_group>
    <arm_group_label>Cell Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intramyocardial injection of autologous bone marrow-derived cells</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Saline injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cell Therapy</intervention_name>
    <description>Intramyocardial injection of autologous bone marrow-derived cells</description>
    <arm_group_label>Cell Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  symptoms of angina or angina equivalent&#xD;
&#xD;
          -  documented coronary artery disease (invasive angiography)&#xD;
&#xD;
          -  documented myocardial ischemia (stress echo, cardiac scintigraphy, or MRI)&#xD;
&#xD;
          -  unsuitable for complete myocardial revascularization (PCI or CABG) OR even if a&#xD;
             complete procedure in feasible, it is anticipated that myocardial perfusion may not be&#xD;
             restored due to poor distal beds&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe LV dysfunction (EF &lt; 25% on echo)&#xD;
&#xD;
          -  short life expectacy (below &lt; 1 year)&#xD;
&#xD;
          -  diagnosis of cancer in the past 5 years&#xD;
&#xD;
          -  diagnosis of hematological diseases&#xD;
&#xD;
          -  diagnosis of severe heart disease of other etiologies including valvular heart&#xD;
             disease, Chagas' disease, etc)&#xD;
&#xD;
          -  diagnosis of acute coronary syndrome in the past 3 months&#xD;
&#xD;
          -  diagnosis of chronic kidney disease stage V requiring chronic dialysis&#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>Jose Eduardo Krieger, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Heart Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlos Eduardo Rochitte, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Institute</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Tura BR, Martino HF, Gowdak LH, dos Santos RR, Dohmann HF, Krieger JE, Feitosa G, Vilas-Boas F, Oliveira SA, Silva SA, Bozza AZ, Borojevic R, de Carvalho AC. Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study. Trials. 2007 Jan 18;8:2. doi: 10.1186/1745-6215-8-2.</citation>
    <PMID>17233910</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>August 28, 2019</last_update_submitted>
  <last_update_submitted_qc>August 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Health, Brazil</investigator_affiliation>
    <investigator_full_name>Luis Henrique W Gowdak, MD, PhD</investigator_full_name>
    <investigator_title>Clinical Coordinator</investigator_title>
  </responsible_party>
  <keyword>Chronic ischemic heart disease</keyword>
  <keyword>Coronary artery disease</keyword>
  <keyword>Angina pectoris</keyword>
  <keyword>Myocardial ischemia</keyword>
  <keyword>Cardiac surgery</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>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01727063
org study id: EMRTCC-ISQ2
nct id: NCT01727063
lead sponsor: 
has dmc: Yes
Patients with advanced coronary artery disease usually undergo incomplete myocardial
      revascularization due to the extension and diffuseness of the disease, with very poor distal
      arterial beds unsuitable for direct revascularization.

      This study was designed to test the hypothesis that direct, intramyocardial injection of
      autologous bone marrow cells may further improve myocardial perfusion in patients undergoing
      incomplete bypass surgery.
All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously
      identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be
      randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived
      cells (BMC) during surgery.

      During follow-up, myocardial perfusion assessment will be performed to determine the
      improvement in treated areas compared to non-treated segments.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intramyocardial injection of bone marrow-derived cells OR placebo (saline) during CABG
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Increase in myocardial perfusion
time frame: 1, 6 and 12 months
description: Patients will undergo myocardial perfusion assessment by MRI during pharmacological stress with adenosine or dipyridamole. Alternatively, cardiac scintigraphy can be used in patients with contra-indications to MRI.
measure: Improvement in LV function
time frame: 1, 6 and 12 months
description: LV function (global and regional) will be assessed by MRI.
measure: Improvement in angina functional class
time frame: 1, 6 and 12 months
description: Angina functional class will be determined using the Canadian Cardiovascular Society classification.
arm group label: Cell Therapy
arm group type: Experimental
description: Intramyocardial injection of autologous bone marrow-derived cells
arm group label: Placebo
arm group type: No Intervention
description: Saline injection
intervention type: Procedure
intervention name: Cell Therapy
description: Intramyocardial injection of autologous bone marrow-derived cells
arm group label: Cell Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jose Eduardo Krieger, MD, PhD
role: Study Director
affiliation: Heart Institute
last name: Carlos Eduardo Rochitte, MD, PhD
role: Study Chair
affiliation: Heart Institute
facility: 
country: Brazil
citation: Tura BR, Martino HF, Gowdak LH, dos Santos RR, Dohmann HF, Krieger JE, Feitosa G, Vilas-Boas F, Oliveira SA, Silva SA, Bozza AZ, Borojevic R, de Carvalho AC. Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study. Trials. 2007 Jan 18;8:2. doi: 10.1186/1745-6215-8-2.
PMID: 17233910
responsible party type: Principal Investigator
investigator affiliation: Ministry of Health, Brazil
investigator full name: Luis Henrique W Gowdak, MD, PhD
investigator title: Clinical Coordinator
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Heart Diseases
mesh term: Angina Pectoris
mesh term: Ischemia