<?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>IRCT20200712048083N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-05</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Coronary angiography via left distal radial artery  vs femoral artery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of coronary angiography and percutaneous coronary intervention via left distal radial artery versus femoral artery in post coronary artery bypass grafting patients; A pilot study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49592</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into into two groups of radial and femoral access by 1:1 simple individual randomization method based on a table of random numbers created by a computer to carry out allocation concealment.
Randomization was performed using "www.random.org" list generator.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Angiography/angioplasty of coronary arteries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In this group, patients undergo angiography or angioplasty through the left distal radial artery and the two groups are compared in terms of contrast volume, fluoroscopic time, vascular complications after the procedure at the site of sheath implantation, total procedure time, amount of radiation received, amount of heparin, vascular spasm in radial method, number of wire and catheter used. Intervention 2: Intervention group 2: In this group, patients undergo angiography or angioplasty through the femoral artery and the two groups are compared in terms of contrast volume, fluoroscopic time, vascular complications after the procedure at the site of sheath implantation, total procedure time, amount of radiation received, amount of heparin, vascular spasm in radial method, number of wire and catheter used.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Lale Farzadi Niaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Heart Center, North Kargar St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713138</zip>
        <telephone>009888029600</telephone>
        <email>lale_farzadi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Lale Farzadi Niaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Heart Center, North Kargar St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713138</zip>
        <telephone>009888029600</telephone>
        <email>lale_farzadi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 90 years
History of coronary artery bypass graft surgery
clinical indication for coronary and graft angiography and/or intervention
No contraindication for contrast agents
Able to provide informed consent
Normal Allen test</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Vascular disorder that makes it difficult to access the femoral or radial arteries</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z98.61</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronary angioplasty status</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>Intervention group 1: In this group, patients undergo angiography or angioplasty through the left distal radial artery and the two groups are compared in terms of contrast volume, fluoroscopic time, vascular complications after the procedure at the site of sheath implantation, total procedure time, amount of radiation received, amount of heparin, vascular spasm in radial method, number of wire and catheter used.</i_keyword>
      <i_keyword>Intervention group 2: In this group, patients undergo angiography or angioplasty through the femoral artery and the two groups are compared in terms of contrast volume, fluoroscopic time, vascular complications after the procedure at the site of sheath implantation, total procedure time, amount of radiation received, amount of heparin, vascular spasm in radial method, number of wire and catheter used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Contrast volume. Timepoint: During procedure. Method of measurement: Using the container  in the angiography room, the amount of Contrast volume consumption is calculated from the beginning to the end of the procedure.</prim_outcome>
      <prim_outcome>Fluoroscopic time. Timepoint: During procedure. Method of measurement: Using the calculations of the device used in the angiography room - Artis zee-siemens - Philips Aluuura FD10 &amp; FD20.</prim_outcome>
      <prim_outcome>Vascular complications after the procedure at the site of sheath implantation. Timepoint: During the procedure, after the procedure, and at the time of discharge. Method of measurement: Based on examination and use of Reverse barbeau test.</prim_outcome>
      <prim_outcome>Total procedure time. Timepoint: During procedure. Method of measurement: From the time of lidocaine injection until the end of the procedure is recorded by the operator.</prim_outcome>
      <prim_outcome>Amount of radiation received. Timepoint: During procedure. Method of measurement: Based on the calculation of the angiography device (DAD and A.K).</prim_outcome>
      <prim_outcome>Amount of Heparin. Timepoint: During procedure. Method of measurement: Based on the amount of heparin unit injected into the patient during the procedure, which is recorded by the operator.</prim_outcome>
      <prim_outcome>Vascular spasm in radial method. Timepoint: During procedure. Method of measurement: Radial Spasm Grading due to physical exam then Matching with the corresponding algorithm.</prim_outcome>
      <prim_outcome>Number of wire and catheters used. Timepoint: During procedure. Method of measurement: Number of wires and catheters consumed during the procedure recorded by the operator.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-20</approval_date>
        <contact_name>Cardiovascular Ethics Committee of Tehran Heart Center</contact_name>
        <contact_address>Tehran Heart Center , north karegar st,Tehran Town tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
