<?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>IRCT20220809055645N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-26</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Outcomes of early discharge in patients with myocardial infarction</public_title>
      <acronym></acronym>
      <scientific_title>Study the outcomes of early hospital discharge in patients with ST Elevation Myocardial Infarction after primary PCI</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>228</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70271</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: In this study, in order to assign patients to intervention and non-intervention groups, a limited randomization approach with block randomization method will be used.Random allocation is considered based on 114 4-fold blocks. It is done through random allocation software.The sequence list of these patients is attached to the proposal. After the study, the list is kept in a sealed lock envelope at the Cardiac Research Center. After starting the study, this list is read daily and patients are placed in early discharge (A) and routine (B) groups according to the sequence of the list.</study_design>
      <phase>N/A</phase>
      <hc_freetext>ST elevation (STEMI) myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They will be discharged from hospital within 48 hours. Intervention 2: Control group: According to conventional protocol, they will be discharged from the department after more than 72 hours.</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:
All data except personal information (name, contact number, file number) can be published.

When:
After publishing the results

To whom:
Available to service providers such as doctors and nurses.

Conditions:
After obtaining permission from the project manager, the information will be usable.

Where to obtain:
Project manager

How to obtain:
By email to the project manager

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Baharvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kooye Bayani</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55588</zip>
        <telephone>+98 13 3366 4282</telephone>
        <email>dr.baharcardio@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Baharvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kooye Bayani</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55588</zip>
        <telephone>+98 13 3366 4282</telephone>
        <email>dr.baharcardio@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>STEMI patients who undergo PCI primary with femoral access by an operator.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>have had a life-threatening disease
The left ventricular ejection fraction (LVEF) has been less than 30 percent.
The patient's age is over 75 years old.
The patient will have pulmonary edema ( Killip class II,III,IV)
Each of the cases and criteria for occurrence of Major adverse cardiovascular events (MACE) included: acute myocardial infarction, acute coronary syndrome or ischemic heart disease (ACS/IHD), stroke (ischemic or hemorrhagic stroke), cardiovascular death (CV), and death by any cause.
Patients who were readmitted.
were not willing to continue to participate in the research.
Perform Primary PCI with Radial Access were removed from the design.</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: They will be discharged from hospital within 48 hours.</i_keyword>
      <i_keyword>Control group: According to conventional protocol, they will be discharged from the department after more than 72 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total deaths. Timepoint: In the study, follow-up of patients during the 2nd and 6th weeks is performed in person by the attending physician to assess each of the mentioned outcomes. Method of measurement: Getting a report and follow up after discharge.</prim_outcome>
      <prim_outcome>Myocardial Infarction. Timepoint: In the study, follow-up of patients during the 2nd and 6th weeks is performed in person by the attending physician to assess each of the mentioned outcomes. Method of measurement: Based on the ECG of the patient's blood pressure (relative to the basal state).</prim_outcome>
      <prim_outcome>Stroke. Timepoint: In the study, follow-up of patients during the 2nd and 6th weeks is performed in person by the attending physician to assess each of the mentioned outcomes. Method of measurement: CT_SCAN MRI.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Readmission. Timepoint: In the study, follow-up of patients during the 2nd and 6th weeks is performed in person by the attending physician to assess each of the mentioned outcomes. Method of measurement: Getting a report and follow up after discharge.</sec_outcome>
      <sec_outcome>Require Revocularization. Timepoint: In the study, follow-up of patients during the 2nd and 6th weeks is performed in person by the attending physician to assess each of the mentioned outcomes. Method of measurement: Based on patient reference records, in-person examination in weeks 2 and 6.</sec_outcome>
      <sec_outcome>Recurrent chest pain. Timepoint: In the study, follow-up of patients during the 2nd and 6th weeks is performed in person by the attending physician to assess each of the mentioned outcomes. Method of measurement: Getting a report and follow up after discharge.</sec_outcome>
      <sec_outcome>Arrhythmias. Timepoint: In the study, follow-up of patients during the 2nd and 6th weeks is performed in person by the attending physician to assess each of the mentioned outcomes. Method of measurement: Based on the ECG of the patient's blood pressure (relative to the basal state).</sec_outcome>
      <sec_outcome>Acute recurrent myocardial infarction. Timepoint: In the study, follow-up of patients during the 2nd and 6th weeks is performed in person by the attending physician to assess each of the mentioned outcomes. Method of measurement: Based on the ECG of the patient's blood pressure (relative to the basal state).</sec_outcome>
      <sec_outcome>Acute recurrent Coronary Syndrome. Timepoint: In the study, follow-up of patients during the 2nd and 6th weeks is performed in person by the attending physician to assess each of the mentioned outcomes. Method of measurement: Based on the ECG of the patient's blood pressure (relative to the basal state).</sec_outcome>
      <sec_outcome>Compliance to the drug. Timepoint: In the study, follow-up of patients during the 2nd and 6th weeks is performed in person by the attending physician to assess each of the mentioned outcomes. Method of measurement: Getting a report after discharge and during secondary referral to follow up the patient's heart condition.</sec_outcome>
      <sec_outcome>Lung edema. Timepoint: In the study, follow-up of patients during the 2nd and 6th weeks is performed in person by the attending physician to assess each of the mentioned outcomes. Method of measurement: Use the Killip class criterion.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-03</approval_date>
        <contact_name>Research Ethics Committees of Guilan University of Medical Sciences</contact_name>
        <contact_address>Namjoo Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
