<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20240121060750N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-03</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of two methods of coronary artery bypass surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of  single versus sequential aortic side biting clamp for restoration of venoaortic anastomosis in coronary artery bypass surgery (CABG) patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75216</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Coronary Artery Bypass Grafting.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In order to perform coronary artery bypass surgery, two surgeons who were similar in terms of surgery time and technique were selected. All surgeries were performed by open heart surgery, under cardiopulmonary pump and cardiac arrest, by injecting cold cardioplegic fluid in the ascending aorta. For the proximal anastomoses of the saphenous vein to the ascending aorta, simple partial clamp technique was used in the control group. In the simple partial clamp method, a large lateral vascular clamp is placed on the ascending aorta, and holes are created in the aorta wall with the number of vein clamps to the aorta by a punch device. All the proximal anastomoses of the vein to the aorta are done by placing this same clamp, and after the end of the last anastomosis, the vascular clamp is opened. While performing all the proximal anastomoses, the previously grafted areas are not supplied with blood. Intervention 2: Intervention group: In the Sequential partial aortic clamp method, a relatively small or medium vascular clamp is used, which closes a small amount of the aorta wall in each stage. At each stage, only one hole in the aorta wall and only one anastomosis between the vein and the aorta were performed. After the end of each anastomosis, the clamp is opened and placed in another part of the aorta, and the next anastomosis is performed in the same way. Therefore, in this method, from the second anastomoses onwards, the previously grafted parts of the myocardium are supplied with blood.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is It is against our policy.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Khajeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Zahra(S) Hospital, Astana Three Roads, Siboye Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>54937-71649</zip>
        <telephone>+98 71 3839 8113</telephone>
        <email>drrkhajeh@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khalil Zarrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Zahra(S) Hospital, Astana Three Roads, Siboye Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>54937-71649</zip>
        <telephone>+98 71 3839 8113</telephone>
        <email>zarrabisx@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients between 18 and 40 years old
Candidate for coronary artery bypass surgery with a diagnosis of coronary artery occlusion.
Patient's informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Positive history of valvular heart diseases
Positive history of recent myocardial infarction
Patients who were at risk of cerebral embolism during ascending aorta clamping</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.810</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerosis of coronary artery bypass graft(s) without angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In order to perform coronary artery bypass surgery, two surgeons who were similar in terms of surgery time and technique were selected. All surgeries were performed by open heart surgery, under cardiopulmonary pump and cardiac arrest, by injecting cold cardioplegic fluid in the ascending aorta. For the proximal anastomoses of the saphenous vein to the ascending aorta, simple partial clamp technique was used in the control group. In the simple partial clamp method, a large lateral vascular clamp is placed on the ascending aorta, and holes are created in the aorta wall with the number of vein clamps to the aorta by a punch device. All the proximal anastomoses of the vein to the aorta are done by placing this same clamp, and after the end of the last anastomosis, the vascular clamp is opened. While performing all the proximal anastomoses, the previously grafted areas are not supplied with blood</i_keyword>
      <i_keyword>Intervention group: In the Sequential partial aortic clamp method, a relatively small or medium vascular clamp is used, which closes a small amount of the aorta wall in each stage. At each stage, only one hole in the aorta wall and only one anastomosis between the vein and the aorta were performed. After the end of each anastomosis, the clamp is opened and placed in another part of the aorta, and the next anastomosis is performed in the same way. Therefore, in this method, from the second anastomoses onwards, the previously grafted parts of the myocardium are supplied with blood.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Troponin. Timepoint: before operation (base),just after operation,24 hours after operation. Method of measurement: ز.</prim_outcome>
      <prim_outcome>Creatine phosphokinase. Timepoint: before operation (base),just after operation,24 hours after operation. Method of measurement: elisa.</prim_outcome>
      <prim_outcome>Cardiac arrhythmia. Timepoint: During the operation, after the operation. Method of measurement: Cardiac monitoring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-22</approval_date>
        <contact_name>Ethics Committee of Shiraz Medical School</contact_name>
        <contact_address>3rd Floor, Building number 3 of Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
