<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/NCT03235323</url>
  </required_header>
  <id_info>
    <org_study_id>LS2017-144</org_study_id>
    <nct_id>NCT03235323</nct_id>
  </id_info>
  <brief_title>Efficacy of External CounterPulsation for Postoperative Coronary Artery Bypass Grafting Patients</brief_title>
  <acronym>SEECABG</acronym>
  <official_title>Study of Efficacy of External CounterPulsation on Reducing the Prevalence of Vein Graft Failure and Improving Cardiac Function for Postoperative Coronary Artery Bypass Grafting Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mengya Liang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital, Sun Yat-Sen 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>
      The aim of this study is to evaluate the effect of External CounterPulsation on postoperative&#xD;
      heart function and vein graft failure rates of coronary artery bypass grafting patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary artery disease (CAD) is prevalent worldwide and the leading cause of mortality of&#xD;
      citizens. Coronary Artery Bypass Grafting (CABG)is one of the major revascularization&#xD;
      procedures for multi-vessel disease nowadays. However vein graft failures (VGF) are known to&#xD;
      occur frequently following CABG surgery . It is estimated that VGF developed in 25% patients&#xD;
      in half a year postoperatively, and up to 50% vein grafts would result in occlusion in ten&#xD;
      years postoperatively. Surgical success depends on the continued patency of grafts, and VGF&#xD;
      has been associated with worse outcomes in CABG patients. Thus prevention of VGF following&#xD;
      CABG is an active area of scientific inquiry. External counter pulsation (ECP) is a&#xD;
      non-invasive method which consists of three sets of pneumatic cuffs attached to each of the&#xD;
      patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered&#xD;
      by a computer, and timing of the inflation is based on the R wave of the electrocardiogram.&#xD;
      The ECP therapist adjusts the inflation and deflation timing to provide optimal blood&#xD;
      movement per a finger plethysmogram waveform reading. This produces a retrograde flow of&#xD;
      blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase&#xD;
      in venous return, which leads to an improved coronary perfusion pressure during diastole.ECP&#xD;
      has been elucidated that it may release angina symptoms and improve the prognosis of CAD,&#xD;
      however, it remained unknown that weather EECP can reduce VGF rates following CABG surgery.&#xD;
      The aim of this study is to evaluate the effect of ECP on heart function of CABG patients and&#xD;
      VGF rates.&#xD;
&#xD;
      To address this investigation, patients underwent CABG with at least one vein graft are&#xD;
      enrolled and randomize them into control or ECP group, the ECP intervention will be carried&#xD;
      out with a standard protocol which involves 35 one-hour sessions (5 days a week) for&#xD;
      continuous 7 weeks, and the follow-up will last for 2 years. The primary endpoints are the&#xD;
      2-year major composite cardiovascular events (MACEs,) and 2-year vein graft patency rate&#xD;
      determined by coronary CT angiography, secondary endpoints include scoring of angina&#xD;
      pectoris, heart function by echocardiography, biomarkers of arteriosclerosis and endothelial&#xD;
      function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Anticipated">August 7, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 7, 2020</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>
    <intervention_model_description>A standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>2-year vein graft patency rate</measure>
    <time_frame>Two years postoperatively</time_frame>
    <description>2-year vein graft patency rate determined by coronary CT angiography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2-year major composite cardiovascular events (MACEs)</measure>
    <time_frame>Two years postoperatively</time_frame>
    <description>2-year major composite cardiovascular events,including STEMI/NSTEMI，readmission of heart attack, renal dialysis and acute heart failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Canadian Cardiovascular Society （CCS） scoring</measure>
    <time_frame>One and two years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>left ventricular end-systolic volume index (LVESVI) and Ejection Fraction</measure>
    <time_frame>One and two years postoperatively</time_frame>
    <description>left ventricular end-systolic volume index (LVESVI) and Ejection Fraction by echocardiography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Counterpulsation</condition>
  <condition>Coronary Artery Bypass</condition>
  <arm_group>
    <arm_group_label>ECP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients of ECP group are subjected to a standard ECP protocol one week postoperatively. A standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients of Control group received routine medicine treatment postoperatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>External Counterpulsation</intervention_name>
    <description>ECP is a non-invasive method which consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. This produces a retrograde flow of blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase in venous return, which leads to an improved coronary perfusion pressure during diastole.</description>
    <arm_group_label>ECP group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients underwent coronary artery bypass grafting surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cerebral hemorrhage within six months;&#xD;
&#xD;
          -  Obvious aortic insufficiency;&#xD;
&#xD;
          -  Aortic aneurysm;&#xD;
&#xD;
          -  Aortic dissection;&#xD;
&#xD;
          -  Coronary fistula or severe coronary aneurysm;&#xD;
&#xD;
          -  Symptomatic Congestive heart failure&#xD;
&#xD;
          -  New York Heart Association（NYHA）heart function class IV&#xD;
&#xD;
          -  Valvular heart disease;&#xD;
&#xD;
          -  Congenital heart diseases;&#xD;
&#xD;
          -  Cardiomyopathies&#xD;
&#xD;
          -  Uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg;&#xD;
&#xD;
          -  Lower limb infection;&#xD;
&#xD;
          -  Deep venous thrombosis;&#xD;
&#xD;
          -  Progressive malignancies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhongkai Wu</last_name>
    <role>Study Director</role>
    <affiliation>Department of Cardiovascular Medcine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mengya Liang, Dr</last_name>
    <phone>+8613560172190</phone>
    <email>infisdsums@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yan Zhang, Dr</last_name>
    <phone>+8618902233602</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of cardiac surgery, The first affiliated hospital of Sun Yat-sen university</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mengya Liang</last_name>
      <phone>+8613560172190</phone>
      <email>infisdsums@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Zhang Y, He X, Chen X, Ma H, Liu D, Luo J, Du Z, Jin Y, Xiong Y, He J, Fang D, Wang K, Lawson WE, Hui JC, Zheng Z, Wu G. Enhanced external counterpulsation inhibits intimal hyperplasia by modifying shear stress responsive gene expression in hypercholesterolemic pigs. Circulation. 2007 Jul 31;116(5):526-34. doi: 10.1161/CIRCULATIONAHA.106.647248. Epub 2007 Jul 9.</citation>
    <PMID>17620513</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Mengya Liang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Vein Graft Failure</keyword>
  <keyword>Coronary Artery Bypass</keyword>
  <keyword>External Counterpulsation</keyword>
  <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/NCT03235323
org study id: LS2017-144
nct id: NCT03235323
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the effect of External CounterPulsation on postoperative
      heart function and vein graft failure rates of coronary artery bypass grafting patients.
Coronary artery disease (CAD) is prevalent worldwide and the leading cause of mortality of
      citizens. Coronary Artery Bypass Grafting (CABG)is one of the major revascularization
      procedures for multi-vessel disease nowadays. However vein graft failures (VGF) are known to
      occur frequently following CABG surgery . It is estimated that VGF developed in 25% patients
      in half a year postoperatively, and up to 50% vein grafts would result in occlusion in ten
      years postoperatively. Surgical success depends on the continued patency of grafts, and VGF
      has been associated with worse outcomes in CABG patients. Thus prevention of VGF following
      CABG is an active area of scientific inquiry. External counter pulsation (ECP) is a
      non-invasive method which consists of three sets of pneumatic cuffs attached to each of the
      patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered
      by a computer, and timing of the inflation is based on the R wave of the electrocardiogram.
      The ECP therapist adjusts the inflation and deflation timing to provide optimal blood
      movement per a finger plethysmogram waveform reading. This produces a retrograde flow of
      blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase
      in venous return, which leads to an improved coronary perfusion pressure during diastole.ECP
      has been elucidated that it may release angina symptoms and improve the prognosis of CAD,
      however, it remained unknown that weather EECP can reduce VGF rates following CABG surgery.
      The aim of this study is to evaluate the effect of ECP on heart function of CABG patients and
      VGF rates.

      To address this investigation, patients underwent CABG with at least one vein graft are
      enrolled and randomize them into control or ECP group, the ECP intervention will be carried
      out with a standard protocol which involves 35 one-hour sessions (5 days a week) for
      continuous 7 weeks, and the follow-up will last for 2 years. The primary endpoints are the
      2-year major composite cardiovascular events (MACEs,) and 2-year vein graft patency rate
      determined by coronary CT angiography, secondary endpoints include scoring of angina
      pectoris, heart function by echocardiography, biomarkers of arteriosclerosis and endothelial
      function.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 2-year vein graft patency rate
time frame: Two years postoperatively
description: 2-year vein graft patency rate determined by coronary CT angiography
measure: 2-year major composite cardiovascular events (MACEs)
time frame: Two years postoperatively
description: 2-year major composite cardiovascular events,including STEMI/NSTEMI，readmission of heart attack, renal dialysis and acute heart failure
measure: Canadian Cardiovascular Society （CCS） scoring
time frame: One and two years postoperatively
measure: left ventricular end-systolic volume index (LVESVI) and Ejection Fraction
time frame: One and two years postoperatively
description: left ventricular end-systolic volume index (LVESVI) and Ejection Fraction by echocardiography
arm group label: ECP group
arm group type: Experimental
description: Patients of ECP group are subjected to a standard ECP protocol one week postoperatively. A standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.
arm group label: Control group
arm group type: No Intervention
description: Patients of Control group received routine medicine treatment postoperatively
intervention type: Device
intervention name: External Counterpulsation
description: ECP is a non-invasive method which consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. This produces a retrograde flow of blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase in venous return, which leads to an improved coronary perfusion pressure during diastole.
arm group label: ECP group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Zhongkai Wu
role: Study Director
affiliation: Department of Cardiovascular Medcine
last name: Mengya Liang, Dr
phone: +8613560172190
email: infisdsums@gmail.com
last name: Yan Zhang, Dr
phone: +8618902233602
facility: 
status: Recruiting
contact: 
country: China
citation: Zhang Y, He X, Chen X, Ma H, Liu D, Luo J, Du Z, Jin Y, Xiong Y, He J, Fang D, Wang K, Lawson WE, Hui JC, Zheng Z, Wu G. Enhanced external counterpulsation inhibits intimal hyperplasia by modifying shear stress responsive gene expression in hypercholesterolemic pigs. Circulation. 2007 Jul 31;116(5):526-34. doi: 10.1161/CIRCULATIONAHA.106.647248. Epub 2007 Jul 9.
PMID: 17620513
responsible party type: Sponsor-Investigator
investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
investigator full name: Mengya Liang
investigator title: Professor
sharing ipd: Undecided