<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/NCT03276624</url>
  </required_header>
  <id_info>
    <org_study_id>CABGlowEF</org_study_id>
    <nct_id>NCT03276624</nct_id>
  </id_info>
  <brief_title>Early Outcome in Unstable Angina Patients With Low EF After CABG</brief_title>
  <official_title>Early Outcome in Chronic Unstable Angina Patients With Low Ejection Fraction After CABG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronary artery bypass grafting (CABG) among patients with reduced myocardial function&#xD;
      remains a surgical challenge despite improvement in surgical technique, myocardial protection&#xD;
      and postoperative care. Such cases are considered as high risk and associated with a higher&#xD;
      peri-operative mortality than those with normal left ventricular function (LVF). Patients&#xD;
      with low EF are at higher risks of sudden death, ventricular arrhythmia, and worsening heart&#xD;
      failure due to recurrent ischemia. Therefore,early recognition of patients at risk for a&#xD;
      worse outcome plays a pivotal role in the decision making process, allowing the prompt&#xD;
      institution of an adequate support.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current treatment options for Chronic Unstable Angina patients with low Ejection Fraction&#xD;
      include intensive medical therapy, surgical revascularization, ventricular remodeling, and&#xD;
      heart transplantation. Medical treatment alone is problematic because of limited long-term&#xD;
      survival. Heart transplantation offers excellent results with a 65.6 % 5-year survival rate;&#xD;
      however, the scarcity of donor organs, the need for lifelong immunosuppression and the fact&#xD;
      that heart transplantation has been restricted to those without co-morbid medical conditions&#xD;
      and relatively restricted to those younger than 65 years of age makes this option impractical&#xD;
      for a majority of patients. As a result, coronary artery bypass graft (CABG) surgery is the&#xD;
      optimal therapeutic approach and remains superior to medical therapy. Numerous controlled&#xD;
      trials of coronary artery bypass grafting in patients with low left ventricular ejection&#xD;
      fraction (LVEF), have shown that these are the patients that benefit most from&#xD;
      revascularization, especially if symptoms of angina or ischemia are present. This benefit is&#xD;
      not only for symptoms, but also on longevity. It is believed that the most important factor&#xD;
      for successful surgical recovery may be the viability of revascularized myocardium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 4, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative Ejection Fraction (EF)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>The EF will be measured 3 months postoperative</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>CABG in Low EF</condition>
  <arm_group>
    <arm_group_label>patients with low EF undergoing CABG</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Chronic Unstable Angina patients with low ejection fraction and a viable myocardium will undergo surgical revascularization CABG</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CABG</intervention_name>
    <description>surgical revascularization of stenosed coranary arteries using arterial and venous grafts.</description>
    <arm_group_label>patients with low EF undergoing CABG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Angiographic indication for revascularization based upon symptoms of angina and/or&#xD;
             objective evidence of myocardial ischemia.&#xD;
&#xD;
          2. Preoperative EF ≤ 40 %.&#xD;
&#xD;
          3. Preoperative myocardial viability (by cardiac MRI).&#xD;
&#xD;
          4. Willing and able to provide written informed consent and comply with study&#xD;
             requirements.&#xD;
&#xD;
          5. Patient is willing to comply with all follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe congestive heart failure (class III or IV according to NYHA, or pulmonary&#xD;
             edema, cardiogenic shock) at the time of enrollment.&#xD;
&#xD;
          2. Prior surgery with the opening of pericardium.&#xD;
&#xD;
          3. Evidence of non-viable (scarred) myocardium.&#xD;
&#xD;
          4. Prior stroke (within 6 months)or more than 6 months if there are substantial&#xD;
             neurological defects.&#xD;
&#xD;
          5. Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization.&#xD;
&#xD;
          6. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g.&#xD;
             valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting).&#xD;
&#xD;
          7. Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding&#xD;
             diathesis.&#xD;
&#xD;
          8. Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine.&#xD;
&#xD;
          9. Extra-cardiac illness that is expected to limit survival to less than 5 years e.g.&#xD;
             oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or&#xD;
             significant hepatic failure, severe renal disease.&#xD;
&#xD;
         10. EF ≤ 20 %.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Elminshawy, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>mahmoud Elkhawaga, master</last_name>
    <phone>01002368945</phone>
    <email>maelkhawaga8@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut University hospitals</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed Elminshawy, professor</last_name>
      <phone>01112743943</phone>
      <email>aelminshawy@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mahmoud Elkhawaga</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angina, Unstable</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/NCT03276624
org study id: CABGlowEF
nct id: NCT03276624
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Coronary artery bypass grafting (CABG) among patients with reduced myocardial function
      remains a surgical challenge despite improvement in surgical technique, myocardial protection
      and postoperative care. Such cases are considered as high risk and associated with a higher
      peri-operative mortality than those with normal left ventricular function (LVF). Patients
      with low EF are at higher risks of sudden death, ventricular arrhythmia, and worsening heart
      failure due to recurrent ischemia. Therefore,early recognition of patients at risk for a
      worse outcome plays a pivotal role in the decision making process, allowing the prompt
      institution of an adequate support.
Current treatment options for Chronic Unstable Angina patients with low Ejection Fraction
      include intensive medical therapy, surgical revascularization, ventricular remodeling, and
      heart transplantation. Medical treatment alone is problematic because of limited long-term
      survival. Heart transplantation offers excellent results with a 65.6 % 5-year survival rate;
      however, the scarcity of donor organs, the need for lifelong immunosuppression and the fact
      that heart transplantation has been restricted to those without co-morbid medical conditions
      and relatively restricted to those younger than 65 years of age makes this option impractical
      for a majority of patients. As a result, coronary artery bypass graft (CABG) surgery is the
      optimal therapeutic approach and remains superior to medical therapy. Numerous controlled
      trials of coronary artery bypass grafting in patients with low left ventricular ejection
      fraction (LVEF), have shown that these are the patients that benefit most from
      revascularization, especially if symptoms of angina or ischemia are present. This benefit is
      not only for symptoms, but also on longevity. It is believed that the most important factor
      for successful surgical recovery may be the viability of revascularized myocardium.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: postoperative Ejection Fraction (EF)
time frame: 3 months postoperative
description: The EF will be measured 3 months postoperative
arm group label: patients with low EF undergoing CABG
arm group type: Other
description: Chronic Unstable Angina patients with low ejection fraction and a viable myocardium will undergo surgical revascularization CABG
intervention type: Procedure
intervention name: CABG
description: surgical revascularization of stenosed coranary arteries using arterial and venous grafts.
arm group label: patients with low EF undergoing CABG
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed Elminshawy, professor
role: Principal Investigator
affiliation: Assiut University
last name: mahmoud Elkhawaga, master
phone: 01002368945
email: maelkhawaga8@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mahmoud Elkhawaga
investigator title: Principal Investigator
mesh term: Angina, Unstable