<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/NCT03275220</url>
  </required_header>
  <id_info>
    <org_study_id>17100309</org_study_id>
    <nct_id>NCT03275220</nct_id>
  </id_info>
  <brief_title>Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University</brief_title>
  <official_title>Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University</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>No</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>
      Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft&#xD;
      In Assiut University&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Right ventricular (RV) dysfunction is a major risk factor in coronary artery disease (CAD)&#xD;
      and patient undergoing revascularization with this combination , incidence of RV dysfunction&#xD;
      is reported in about 20% cases of CAD.&#xD;
&#xD;
      RV dysfunction is a possible cause of cardiac failure after cardiac surgery and has a high&#xD;
      mortality rate.&#xD;
&#xD;
      RV dysfunction is a recognized cause of hypotension early after coronary artery bypass graft&#xD;
      surgery (CABG)&#xD;
&#xD;
      A decrease in RV function is an event known to occur after CABG. Right ventricular&#xD;
      dysfunction can be seen during and immediately after cardiac surgery. Although the mechanism&#xD;
      of this phenomenon is not well understood, cardiopulmonary bypass, perioperative myocardial&#xD;
      ischemia, intraoperative myocardial damage, cardioplegia, and pericardial disruption or&#xD;
      adhesion have been suggested as probable causes.&#xD;
&#xD;
      Major reasons for complications of cardiac surgery are the need for hypothermic cardiac&#xD;
      arrest, aortic cross clamping, and exposure to a cardiopulmonary bypass circuit.&#xD;
&#xD;
      It has been postulated that avoidance of these factors by performing off-pump coronary artery&#xD;
      bypass (OPCAB) surgery might reduce perioperative morbidity and improve outcome.&#xD;
&#xD;
      Recently, the portion of coronary artery bypass grafting on the beating heart without the use&#xD;
      of cardiopulmonary bypass (CPB) has been expanded in cardiac surgery as a result of awareness&#xD;
      of the damaging effect of CPB&#xD;
&#xD;
      Whether OPCAB surgery can fulfill these expectations, or to which degree, is yet unclear.&#xD;
&#xD;
      A few studies on hemodynamic alternations associated with OPCAB reported that reduced&#xD;
      functions of both ventricles during coronary artery anastomosis are the main mechanism of&#xD;
      hemodynamic derangements and especially, impaired diastolic function of the right ventricle&#xD;
      (RV) plays an important role&#xD;
&#xD;
      However, clinical studies evaluating the change in RV function in patients with ischemic&#xD;
      heart disease are very rare. It is reported that the major cause of hemodynamic changes&#xD;
      during OPCAB was disturbed diastolic filling of the RV through the measurement of chamber&#xD;
      pressures or monitoring of echocardiography.&#xD;
&#xD;
      There was no significant change in the RVEF and cardiac index during anastomosis of the left&#xD;
      anterior descending artery and right coronary artery. However, the significantly reduced RVEF&#xD;
      accompanied by an increase in RV afterload and decrease in the CO was observed during&#xD;
      anastomosis of the obtuse marginal (OM) artery. RV volumes did not significantly change&#xD;
      during anastomoses, though the right atrial pressure increased during anastomoses of all&#xD;
      coronary arteries. The displacement of beating heart for positioning during anastomosis of&#xD;
      the graft to OM artery caused significant derangement of RV function and decrease in CO.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 10, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of effects of CABG on right ventricular function</measure>
    <time_frame>6 months</time_frame>
    <description>assessment of right ventricular function in patients undergoing CABG using 2D echocardiography and 3D echocardiography</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>CORONARY ARTERY BYPASS</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>2D Echocardiography and 3D Echocardiography</intervention_name>
    <description>Imaging of right ventricle by 2d echocardiography and 3D echocardiography to assess right ventricular function accurately</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include patients will undergo elective CABG of different ages from&#xD;
        cardiology department, Assiut University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        1. Inclusion criteria:&#xD;
&#xD;
             • Patients will undergo elective CABG in Assiut university hospital&#xD;
&#xD;
          2. Exclusion criteria:&#xD;
&#xD;
               -  Poor echo window.&#xD;
&#xD;
               -  Refusal of the patient&#xD;
&#xD;
               -  Patients with prior RV dysfunction.&#xD;
&#xD;
               -  Patients with LV dysfunction (EF:&lt;40%).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salah Atta</last_name>
    <role>Study Chair</role>
    <affiliation>professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Salma Taha</last_name>
    <role>Study Chair</role>
    <affiliation>lecturer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maria Refaat, master</last_name>
    <phone>01120108960</phone>
    <email>Merofouad307@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>17642</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Maria Refaat, master</last_name>
      <phone>01120108960</phone>
      <email>Merofouad307@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Salah Atta</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Salma Taha</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria Refaat</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Roshanali F, Yousefnia MA, Mandegar MH, Rayatzadeh H, Alinejad S. Decreased right ventricular function after coronary artery bypass grafting. Tex Heart Inst J. 2008;35(3):250-5.</citation>
    <PMID>18941594</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mero Fouad</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03275220
org study id: 17100309
nct id: NCT03275220
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft
      In Assiut University
Right ventricular (RV) dysfunction is a major risk factor in coronary artery disease (CAD)
      and patient undergoing revascularization with this combination , incidence of RV dysfunction
      is reported in about 20% cases of CAD.

      RV dysfunction is a possible cause of cardiac failure after cardiac surgery and has a high
      mortality rate.

      RV dysfunction is a recognized cause of hypotension early after coronary artery bypass graft
      surgery (CABG)

      A decrease in RV function is an event known to occur after CABG. Right ventricular
      dysfunction can be seen during and immediately after cardiac surgery. Although the mechanism
      of this phenomenon is not well understood, cardiopulmonary bypass, perioperative myocardial
      ischemia, intraoperative myocardial damage, cardioplegia, and pericardial disruption or
      adhesion have been suggested as probable causes.

      Major reasons for complications of cardiac surgery are the need for hypothermic cardiac
      arrest, aortic cross clamping, and exposure to a cardiopulmonary bypass circuit.

      It has been postulated that avoidance of these factors by performing off-pump coronary artery
      bypass (OPCAB) surgery might reduce perioperative morbidity and improve outcome.

      Recently, the portion of coronary artery bypass grafting on the beating heart without the use
      of cardiopulmonary bypass (CPB) has been expanded in cardiac surgery as a result of awareness
      of the damaging effect of CPB

      Whether OPCAB surgery can fulfill these expectations, or to which degree, is yet unclear.

      A few studies on hemodynamic alternations associated with OPCAB reported that reduced
      functions of both ventricles during coronary artery anastomosis are the main mechanism of
      hemodynamic derangements and especially, impaired diastolic function of the right ventricle
      (RV) plays an important role

      However, clinical studies evaluating the change in RV function in patients with ischemic
      heart disease are very rare. It is reported that the major cause of hemodynamic changes
      during OPCAB was disturbed diastolic filling of the RV through the measurement of chamber
      pressures or monitoring of echocardiography.

      There was no significant change in the RVEF and cardiac index during anastomosis of the left
      anterior descending artery and right coronary artery. However, the significantly reduced RVEF
      accompanied by an increase in RV afterload and decrease in the CO was observed during
      anastomosis of the obtuse marginal (OM) artery. RV volumes did not significantly change
      during anastomoses, though the right atrial pressure increased during anastomoses of all
      coronary arteries. The displacement of beating heart for positioning during anastomosis of
      the graft to OM artery caused significant derangement of RV function and decrease in CO.
observational model: Cohort
time perspective: Cross-Sectional
measure: Assessment of effects of CABG on right ventricular function
time frame: 6 months
description: assessment of right ventricular function in patients undergoing CABG using 2D echocardiography and 3D echocardiography
intervention type: Diagnostic Test
intervention name: 2D Echocardiography and 3D Echocardiography
description: Imaging of right ventricle by 2d echocardiography and 3D echocardiography to assess right ventricular function accurately
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Salah Atta
role: Study Chair
affiliation: professor
last name: Salma Taha
role: Study Chair
affiliation: lecturer
last name: Maria Refaat, master
phone: 01120108960
email: Merofouad307@yahoo.com
facility: 
contact: 
investigator: 
investigator: 
investigator: 
country: Egypt
citation: Roshanali F, Yousefnia MA, Mandegar MH, Rayatzadeh H, Alinejad S. Decreased right ventricular function after coronary artery bypass grafting. Tex Heart Inst J. 2008;35(3):250-5.
PMID: 18941594
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mero Fouad
investigator title: Principal Investigator
sharing ipd: Undecided