<?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>IRCT20230102057018N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-24</date_registration>
      <primary_sponsor>Research Assistant of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of morphin in prognose of Anterior MI</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of morphine administration on serum CKMB level, ST segment depression and TIMI effect in patients with first acute anterior myocardial infarction who underwent primary coronary angioplasty.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67912</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Other design features: In this study, the dose of morphine received was different compared to similar studies, and also three cases of TIMI FLOW, ST and CKMB levels will be evaluated together for the first time, Randomization description: Restricted randomization(Random allocation rule)/Random allocation software(SAS)/In order to hide, the method of Numbered drug containers will be used, Blinding description: - Apart from knowing the type of study and participation in the study and possible complications, the participant is completely blinded to which group he is in and what the results of the data are like.
- The health personnel have no knowledge of the type and process of the study and only follow the orders
- Those responsible for data collection and those who evaluate the outcome are completely blinded to the study process.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute Anterior ST Elevatiom Myocardial Infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For this group, morphine sulfate is injected in the lab coat and on the angiography bed with a dose of 1 mg intracoronary and 3 mg intravenous. 3 mg of intravenous morphine diluted with 5 cc of distilled water and 1 mg of intracoronary morphine diluted with 5 cc of distilled water and injected only once at the beginning of angioplasty in the doses described. 90 minutes after angioplasty, an electrocardiogram was taken in ccu and compared with the initial tape in terms of ST segment loss. During admission to the ccu and at an interval of 8 hours, blood is taken from the patient up to 3 times and sent to the laboratory to evaluate the level of ckmb. The angiography films are given a TIMI FLOW score according to the final TIMI flow. Intervention 2: Control group: Control group: This group does not receive any morphine and on the angiography bed, only 5 cc of distilled water is injected intracoronary and 5 cc of distilled water intravenously. 90 minutes after angioplasty in the ccu, an ECG is taken from the patients and it is compared with the initial tape in terms of ST segment loss. When entering the ccu and at an interval of 8 hours, the patient's blood is taken 3 times and sent to the laboratory to evaluate the ckmb level. The angiography films will be awarded according to the final TIMI flow by the project manager and the points corresponding to TIMI FLOW will be awarded to them. The implementation of the plan is evaluated and reviewed.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parviz Shahaby</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi St., Golbad St., University Quay, Tabriz university of medical sience</address>
        <city>Tbriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166615573</zip>
        <telephone>009841333900</telephone>
        <email>Tohidyahyapoor1382@gmail.com</email>
        <affiliation>Research Assistant of Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parviz Shahaby</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi St., Golbad St., University Quay,Tabriz university of medical sience</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166615573</zip>
        <telephone>009841333739003</telephone>
        <email>Tohidyahyapoor1382@gmail.com</email>
        <affiliation>Research Assistant of Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Typical cardiac chest pain lasting at least 20 minutes
ST segment elevation of at least 1 mm repeated in two consecutive leads
Q wave not seen with ST segment elevation
patient's first acute anterior myocardial infarction
A heart attack has occurred in the last 6 hours
initial TIMI score is 0 or 1
no morphine injection in the emergency room or before</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>receiving fibrinolytic
receiving cardiac electric shock
resuscitating the patient
being intubated
having VT or VF arrhythmia
history of CABG
complete heart block
respiratory failure
history of liver cirrhosis
early TIMI flow 2 or more</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: For this group, morphine sulfate is injected in the lab coat and on the angiography bed with a dose of 1 mg intracoronary and 3 mg intravenous. 3 mg of intravenous morphine diluted with 5 cc of distilled water and 1 mg of intracoronary morphine diluted with 5 cc of distilled water and injected only once at the beginning of angioplasty in the doses described. 90 minutes after angioplasty, an electrocardiogram was taken in ccu and compared with the initial tape in terms of ST segment loss. During admission to the ccu and at an interval of 8 hours, blood is taken from the patient up to 3 times and sent to the laboratory to evaluate the level of ckmb. The angiography films are given a TIMI FLOW score according to the final TIMI flow.</i_keyword>
      <i_keyword>Control group: Control group: This group does not receive any morphine and on the angiography bed, only 5 cc of distilled water is injected intracoronary and 5 cc of distilled water intravenously. 90 minutes after angioplasty in the ccu, an ECG is taken from the patients and it is compared with the initial tape in terms of ST segment loss. When entering the ccu and at an interval of 8 hours, the patient's blood is taken 3 times and sent to the laboratory to evaluate the ckmb level. The angiography films will be awarded according to the final TIMI flow by the project manager and the points corresponding to TIMI FLOW will be awarded to them. The implementation of the plan is evaluated and reviewed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coronary timi flow. Timepoint: in angiographic last view. Method of measurement: According to the international definition of coronary Timi Flow.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The degree of ST segment depression in the patient's ECG. Timepoint: 90 minutes after the patient enters the CCU. Method of measurement: Obtaining an ECG by the patient's nurse and reading it by a cardiologist.</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>Research Assistant of Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-05</approval_date>
        <contact_name>Research Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Azadi St., Golbad St., University St. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
