<?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>IRCT20190411043242N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-29</date_registration>
      <primary_sponsor>Rajaie cardiovascular medical and research center</primary_sponsor>
      <public_title>Over-sized stenting in primary percutaneous coronary intervention</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of over-sized stenting versus conventional stenting  in patients undergoing primary percutaneous coronary intervention</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38840</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed via permuted block randomization method. Allocation will be generated via a web based system and consequently concealment will be central using computer software. Unit of randomization will be individual patients and no stratification will be applied, Blinding description: Only participant in this study were be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patient with acute myocardial infarction undergoing primary  coronary angioplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  oversized stenting. In interventional group, after diagnostic angiography, intracoronary nitroglycerin will be injected and infarcted vessel size in the proximal and distal section was measured by quantitative coronary analysis system . Then considering average of vessel diameter and operator decision the size of stent was chosen and 10% oversizing was done. Intervention 2: Control group: Nonoversized sternting. In control group, after after diagnostic angiography, intracoronary nitroglycerin will be injected and infarcted vessel size in the proximal and distal section was measured by quantitative coronary analysis system . Then considering average of vessel diameter and operator decision the size of stent was chosen but it will not be oversized.</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 Unavailability of resources</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Ali Banifatemeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hashemi Rafsanjani highway, Valiasr street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996911151</zip>
        <telephone>+98 21 2266 3249</telephone>
        <email>Banifatemeh_cardio@yahoo.com</email>
        <affiliation>Rajaie cardiovascular medical and research center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Firouzi Ata</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hashemi Rafsanjani highway, Valiasr street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996911151</zip>
        <telephone>+98 21 2266 3249</telephone>
        <email>atafirouzi@yahoo.com</email>
        <affiliation>Rajaie cardiovascular medical and research center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with acute myocardial infarction with &gt;0.1 mV ST-segment elevation from baseline in at least two contiguous leads on the 12-lead electrocardiogram who were candidate for primary percutaneous intervention</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Primary percutaneous coronary intervention without stenting
Primary percutaneous coronary intervention of saphenus vein graft
Rescue  Primary percutaneous coronary intervention
stent thrombosis myocardial infarction
Electrocardiogram data inadequate to measure ST resolution</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ST elevation (STEMI) myocardial infarction of unspecified site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  oversized stenting. In interventional group, after diagnostic angiography, intracoronary nitroglycerin will be injected and infarcted vessel size in the proximal and distal section was measured by quantitative coronary analysis system . Then considering average of vessel diameter and operator decision the size of stent was chosen and 10% oversizing was done.</i_keyword>
      <i_keyword>Control group: Nonoversized sternting. In control group, after after diagnostic angiography, intracoronary nitroglycerin will be injected and infarcted vessel size in the proximal and distal section was measured by quantitative coronary analysis system . Then considering average of vessel diameter and operator decision the size of stent was chosen but it will not be oversized.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiac enzyme level. Timepoint: twelve hours after procedure. Method of measurement: Lab kit.</prim_outcome>
      <prim_outcome>ST segment resolution. Timepoint: 60 minute after procedure. Method of measurement: electrocardiogram.</prim_outcome>
      <prim_outcome>No Reflow phenomenon. Timepoint: after stent implantation. Method of measurement: angiography.</prim_outcome>
      <prim_outcome>Hospital stay. Timepoint: hospital course. Method of measurement: patient profile.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Target vessel revascularization. Timepoint: six months after intervention. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Reinfarction. Timepoint: six months after intervention. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Cardiovascular death. Timepoint: six months after intervention. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>All cause death. Timepoint: six months after intervention. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Congestive heart failure. Timepoint: six months after intervention. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Cardiovascular accident. Timepoint: six months after intervention. Method of measurement: Medical record.</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>Rajaie Cardiovascular Medical and Research center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-15</approval_date>
        <contact_name>Ethics committee of Rajaie Cardiovascular, Medical &amp; Research Center</contact_name>
        <contact_address>Hashemi Rafsanjani highway, Valiasr street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
