<?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>IRCT20190611043864N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-30</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>Low-dose ketamine effectiveness in acute coronary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>: Low-dose ketamine effectiveness in acute coronary syndrome with opioid unresponsive or hemodynamically unstable patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50114</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are readily available in the study (recruitment) and are divided into two groups of intervention and control based on random allocation (random block).
Block Randomization method using the site (https://www.sealedenvelope.com/simple) has been used to assign samples to the intervention and control groups. 35 blocks of 4 with a specific code are prepared and used, Blinding description: The method of blinding is that the five-digit serial numbers produced in the process of random allocation are placed in sealed envelopes and assigned by an independent person from the research team and by telephone to each of the eligible individuals.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute Coronary Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  A group of patients receiving low-dose ketamine as part of treatment (0.1-0.3 mg / kg). Intervention 2: Control group:  A group of patients who do not receive low-dose ketamine as part of treatment (0.1-0.3 mg / kg).</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 I have to consult with my teachers.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mehdi Rezaei Kojani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rajaei Hospital-Hesarak-Karaj-Alborz province-Iran</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3197635141</zip>
        <telephone>+98 26 3455 2001</telephone>
        <email>rezaei.mehdi.md@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mehdi Rezaei Kojani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rajaei Hospital-Hesarak-Karaj-Alborz province-Iran</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3197635141</zip>
        <telephone>+98 26 3455 2001</telephone>
        <email>reaei.mehdi.md@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>-Age above 18 years old
-Age below 65 years old
-Satisfaction for participating in study
-Patients with acute coronary syndrome that has VAS more or equal to 9 and unstable haemodynamic (Systolic blood pressure less than or equal to 90 mm Hg or diastolic blood pressure less than or equal to 60 mm Hg or both)
-Lack of precedent of sensitiveness to ketamine</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>-Dissatisfaction for participating in study
-Age below than 18 years old
-Age above than 65 years old
-Weight below than 40 Kg
-Drug or alcohol intoxication
-Active psychiatric disorder
-Heart rate more than 100 per minute</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I60-I69</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischaemic heart diseases</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:  A group of patients receiving low-dose ketamine as part of treatment (0.1-0.3 mg / kg)</i_keyword>
      <i_keyword>Control group:  A group of patients who do not receive low-dose ketamine as part of treatment (0.1-0.3 mg / kg)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 0-15 minutes -30 minutes -45 minutes. Method of measurement: 10-visual analogue scale (VAS) - by the patient.</prim_outcome>
      <prim_outcome>The amount of pethidine consumed. Timepoint: 0, 15, 30, 45 minutes. Method of measurement: Based on milligram of drug used. observe and record files.</prim_outcome>
      <prim_outcome>Confusion. Timepoint: 0, 15, 30, 45 minutes. Method of measurement: History and physical examination.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: 0, 15, 30, 45 minutes. Method of measurement: physical examination.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: 0, 15, 30, 45 minutes. Method of measurement: sphygmomanometer cuff based on millimeter of Hg.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: 0, 15, 30, 45 minutes. Method of measurement: sphygmomanometer cuff based on millimeter of Hg.</prim_outcome>
      <prim_outcome>Drowsiness. Timepoint: 0, 15, 30, 45 minutes. Method of measurement: History and physical examination.</prim_outcome>
      <prim_outcome>Vertigo. Timepoint: 0, 15, 30, 45 minutes. Method of measurement: History and physical examination.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: 0, 15, 30, 45 minutes. Method of measurement: History and physical examination.</prim_outcome>
      <prim_outcome>Headache. Timepoint: 0, 15, 30, 45 minutes. Method of measurement: History and physical examination.</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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-30</approval_date>
        <contact_name>Research Ethics Committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>unit4,No42,17th shahrivar ave,shahid Beheshti st Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
