<?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>IRCT20210215050365N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-01</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of rotational angiography with standard (traditional) angiography</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of rotational angiography with standard (traditional) angiography in patients referred to the Cardiac Center affiliated to Qazvin University of Medical Sciences in 2020-2021</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56047</url>
      <study_type>observational</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Due to the ease of use and cost savings in time, participants were divided into two groups using random sequence generation software. In this way, information such as sample size and number of groups is given to the software and the software provides a table of random numbers, each of which is randomly assigned the letters A and B. In this study, A numbers are in the standard (traditional) angiography group and B numbers are in the rotational angiography group, Blinding description: The study was performed blindly. In this study, the data analyzer did not know the type of method used on patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Angiography.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Rotational angiography. Intervention 2: Control group:  standard angiography (common).</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 collected information is in the form of a questionnaire and is statistically analyzed.

When:
The start of the access period is one year after the results are published.

To whom:
For cardiologists and researchers working in academic institutions

Conditions:
Users can evaluate the study path and process.

Where to obtain:
For information, refer to Dr. Mohammad Reza Kheiri. The communication channels are in the following order: by e-mail to the address: afikhob56@gmail.com or refer to and contact the Bu Ali Sina Hospital in Qazvin at the address: Qazvin, Bu Ali Street. Phone: 33332930-028 Postal address: 86165 - 34137

How to obtain:
After sending the e-mail, the requested information will be reviewed by the facilitator and the person responsible for the scientific response of the study. At your discretion, the requested information will be sent within 10 days after receiving the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Kheiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Shahid Bahonar blvd</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413786313</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>afikhob56@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Mahdi Daei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413786165</zip>
        <telephone>+98 28 3333 2931</telephone>
        <email>afikhob@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Early diagnosis of coronary artery disease
Angiography through the right femoral artery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction with the procedure
Emergency angiography
Hemodynamic disorders
The patient's high weight</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: Rotational angiography</i_keyword>
      <i_keyword>Control group:  standard angiography (common)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of contrast agent injected. Timepoint: After angiography. Method of measurement: Based on the amount of cc used by the operator.</prim_outcome>
      <prim_outcome>The amount of radiation emitted. Timepoint: After angiography. Method of measurement: It is recorded by angiography device.</prim_outcome>
      <prim_outcome>Fluoroscopic duration. Timepoint: After angiography. Method of measurement: It is recorded by angiography device.</prim_outcome>
      <prim_outcome>It is recorded by angiography device. Timepoint: After angiography. Method of measurement: It is recorded by angiography device.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-10</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
