<?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>IRCT20200510047380N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-15</date_registration>
      <primary_sponsor>Vice-Chancellor For Research and Technology of Guilan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of timing of heparin injection on acute STEMI treatment</public_title>
      <acronym></acronym>
      <scientific_title>The effect of timing of Heparin injection on the TIMI Flow grade in the STEMI patients undergoing  primary PCI</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47992</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects with eligible criteria are randomly assigned into two groups using the random block method with size 4. These patients will be divided into two groups: early heparin administration group in the emergency department, and late heparin administration group in the cath lab unit. Random sequences will be generated using computer. After generating the list, a specific code will be assigned to each person, and will be identified by it during the study. Registration and the sequence of random allocation is done by a third person. The sampling method is consecutive. Sampling is started based on the patients’ gradual referrals to the emergency department and completed documents, and will be continued to reach the required sample size.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute myocardial infarction with ST elevation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients with STEMI in intervention group whom will receive bolus dose of 90u/kg IV heparin UFH in emergency department. Intervention 2: Control group: bolus 90 u/kg IV heparin as hospital routine and during PCI.</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:
Spss file will include all data about acute MI (onset of chest pain, duration of chest pain, anterior ,lateral, high lateral , extensive anterolateral, inferior, posterior, septal, RV MI) 
 , LVEF during hospitalization, heart rate on the electrocardiogram, systolic and diastolic blood pressure, killip class , treatment group, 
Early Bolus heparin administration in emergency department and 
Late bolus heparin in the catch lab, and referring for CABG.
Angiographic and angioplastic data including 
Identifiable culprit vessel, vascular access 
TIMI FLOW of culprit vessel:   , LM،LAD،Diagonal، LCX، OM، RCA، PDA
Before and after Primary PCI, HOSPITAL complications ( stent thrombosis,  local side effects of angiography including bleeding and hematoma, ventricular tachyarrhythmia (VT,VF) Flail MV, Vntricular septal rupture , free wall rupture , pericardial effusion.
Clinical data about LVEF 40 days after STEMI.

When:
6 month after the results are published, the access period will be start.

To whom:
Researchers working in academic and scientific institutions.

Conditions:
To obtain new results, researchers will be permitted to use further analysis and the data in the future researches.

Where to obtain:
Healthy Heart Research Center, Dr Heshmat heart hospital, Mosalla Square, Rasht, Guilan, Iran Phone number: 00981333664282 P.O.Box: 41939-55588
Fax: 00981333668718

How to obtain:
A written request with sufficient detail should be sent to the postal address.After receiving the request, the scientific correspondence author will be responsive within one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Aboozar Fakhr Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Healthy Heart Research Center, Heshmat Heart Hospital, Mosalla square, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55588</zip>
        <telephone>+98 13 3366 4282</telephone>
        <email>fakhrmousavi@gums.ac.ir</email>
        <affiliation>Healthy Heart Research Center of Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Aboozar Fakhr Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Healthy Heart Research Center, Heshmat Heart Hospital, Mosalla square, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55588</zip>
        <telephone>+98 13 3366 4282</telephone>
        <email>fakhrmousavi@gums.ac.ir</email>
        <affiliation>Healthy Heart Research Center of Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with STEMI who are willing to participate in this study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients receiving thrombotic medicine during past seven days
Pregnancy
Active bleeding
Thrombocytopenia history with heparin
Receiving heparin before hospitalization
History of thrombocytopenia
History of CABG
Age over 75
Failed Primary PCI</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ST elevation (STEMI) myocardial infarction of anterior wall</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with STEMI in intervention group whom will receive bolus dose of 90u/kg IV heparin UFH in emergency department</i_keyword>
      <i_keyword>Control group: bolus 90 u/kg IV heparin as hospital routine and during PCI.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>TIMI Flow grade. Timepoint: Once during coronary Angiography and before angioplasty, then after Primary PCI over culprit vessel. Method of measurement: Coronary Angiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Left Ventricular Ejection Fraction (LVEF). Timepoint: 40 days after STEMI. Method of measurement: Echocardiography.</sec_outcome>
      <sec_outcome>Pericardial effusion. Timepoint: 40 days after STEMI. Method of measurement: Echocardiography.</sec_outcome>
      <sec_outcome>Free wall rupture. Timepoint: 40 days after STEMI. Method of measurement: Echocardiography.</sec_outcome>
      <sec_outcome>FLAIL Mitral valve. Timepoint: 40 days after STEMI. Method of measurement: Echocardiography.</sec_outcome>
      <sec_outcome>Ventricular Septal Rupture (VSR). Timepoint: 40 days after STEMI. Method of measurement: Echocardiography.</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>Vice-Chancellor For Research and Technology of Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-06</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Vice-Chancellor For Research and Technology of Guilan University of Medical Sciences, infront of 17 Shahrivar hospital, Shahid Siadati street, Namjoo street, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
