<?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>IRCT20180306038978N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-28</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cardiac remote ischemic preconditioning (IRPC) on the release of cardiac troponin I after elective percutaneous coronary intervention (PCI)</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cardiac remote ischemic preconditioning (IRPC) on the release of cardiac troponin I after elective percutaneous coronary intervention (PCI) in outpatients admitted to the angiography ward</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>240</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34206</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Subjects were randomized into two groups by means of a randomization table acquired from the Random Allocation software. for example:
0001: Control	0041: Case	0081: Case	0121: Case	0161: Control	0201: Case.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ischemic heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: An hour before percutaneous coronary intervention a blood pressure cuff will be placed around the non-dominant arm of the patients, then it will be inflated up to 200 mmHg for 5 minutes, afterwards the cuff will be deflated for 5 minutes and this cycle will be repeated two more times. Intervention 2: Control group: An hour before percutaneous coronary intervention deflated blood pressure cuff will be placed on the non-dominant arm of the patients for 30 minutes.</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:
Primary outcome and demographic data

When:
Starting 1 year after publication of the results

To whom:
Researchers working in academic institutions

Conditions:
Only analyses not indicated in the published article are allowed.

Where to obtain:
Applicants can use the following email address to submit their requests and an SPSS data file will be available to them. 
shoeibpaskhandi@yahoo.com

How to obtain:
Valid identification card indicating that the applicant is a member of academic institutions

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shoeib Paskhandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bandar Abbas Faculty of Medicine, Imam Hossein Blvd., Hormozgan, Iran</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919693116</zip>
        <telephone>+98 76 3371 0370</telephone>
        <email>hums@hums.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shoeib Paskhandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bandar Abbas Faculty of Medicine, Imam Hossein Blvd., Bandar Abbas, Hormozgan, Iran</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919693116</zip>
        <telephone>+98 76 3371 0370</telephone>
        <email>hums@hums.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 18  years or older
Stable coronary artery disease
Requirement of elective PCI</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Emergency PCI
Renal dysfucntion
High cardiac troponin levels before PCI
Women of childbearing age
Use of Nicorandil or Glibenclamide
Severe comorbidities  (terminal illnesses,  advanced cancers with low life expectancy, renal failure, hepatic failure, rheumatic diseases)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute ischemic heart disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: An hour before percutaneous coronary intervention a blood pressure cuff will be placed around the non-dominant arm of the patients, then it will be inflated up to 200 mmHg for 5 minutes, afterwards the cuff will be deflated for 5 minutes and this cycle will be repeated two more times.</i_keyword>
      <i_keyword>Control group: An hour before percutaneous coronary intervention deflated blood pressure cuff will be placed on the non-dominant arm of the patients for 30 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiac troponin I. Timepoint: Cardiac troponin I is measured right before  and 18 hours after percutaneous coronary intervention. Method of measurement: Quantitative measurement of cardiac troponin I using enzymatic method.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-06</approval_date>
        <contact_name>Ethics Committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Jomhouri Eslami Blvd, Shahid Mohammadi Hospital, Bandar Abbas Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
