<?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>IRCT20211225053517N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-11</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effects of vasodilator (nitroglycerin-TNG) in Cardioplegic Solution myocardial ischemia in patients treated with coronary artery bypass graft surgery in Chamran Hospital, Isfahan</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effects of vasodilator (nitroglycerin-TNG) in Cardioplegic Solution myocardial ischemia in patients treated with coronary artery bypass graft surgery in Chamran Hospital, Isfahan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60869</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling method is a simple individual randomization method that was performed using SPSS statistical software and blind three-way, Blinding description: Lack of information of the participant evaluating the outcome and analyzing the data.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Cardiovascular surgery.</hc_freetext>
      <i_freetext>Intervention 1: Addition of injectable nitroglycerin to weight-based cardioplegia solution. Intervention 2: Control group: Nitroglycerin-free cardioplegia solution.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The result of the clinical trial will be published after the thesis is approved

When:
Access period starts 6 months after the results are published

To whom:
Researcher working in academic and scientific institutions

Conditions:
For use in future studies

Where to obtain:
Fatemeh Amiri Dehnavi

How to obtain:
Refer to the database of Isfahan University, thesis section

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 110 Dastgerd St., Shahid Safarian Alley, 2 dead end,</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174854511</zip>
        <telephone>+98 31 3776 8614</telephone>
        <email>amirif319@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seyed Alireza Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Chamran Hospital</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8166173414</zip>
        <telephone>+98 31 3260 0961</telephone>
        <email>hosseiny@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>In this study, patients with Serener's disease who will undergo CABG.
EF more than 40%
Age between 35 and 70 years
Candidates for non-emergency surgery
Pump time between one to two hours
Arrest time between 30 -100 minutes</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients in cardiogenic shock and patients receiving known antioxidants such as captopril mannitol or allopurinol will be excluded from the study.
Also unpredictable events that disrupt the normal surgical process, such as the use of an intra-aortic pump balloon and ECMO, cardiac arrest,
The length of stay in the ICU for more than five days will result in the removal of the sample.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Addition of injectable nitroglycerin to weight-based cardioplegia solution</i_keyword>
      <i_keyword>Control group: Nitroglycerin-free cardioplegia solution</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Evaluation of changes in troponin and CPK in patients undergoing open heart surgery with nitroglycerin effect. Timepoint: Measurement of troponin and CPK before and after surgery. Method of measurement: Vidas device for troponin check and BT3000 device for CPK check.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-26</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>No 110 Dastgerd Street, Shahid Safarian 2 Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
