<?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>IRCT20200617047814N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-04</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Remote Ischemic preconditioning effect for prevention of contrast-induced nephropathy</public_title>
      <acronym></acronym>
      <scientific_title>Remote Ischemic preconditioning effect for prevention of contrast-induced nephropathy  in patients with coronary angiography/angioplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49028</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patient block randomization is performed using the website www.randomization.com, and patient codes are generated with envelope letters in which the data is not clear, and each of the random questions generated is recorded on a single card and the card is inserted into the packet, Blinding description: In the method, none of the patients and angiography/angioplasty operators and researcher will be aware of patient coding and grouping. 
The clinical caregiver performs the intervention in the intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Contrast induced nephropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, 45 minutes before angiography/angioplasty under induction ischemia with blood pressure cuff in the elbow area by inflating the cuff 50 mm Hg above systolic pressure in 5-minute for 4 cycles and 5-minute emptying between cycles with hydration. Standard treatment (hydration) is performed for all patients in the intervention and control group. If creatinine increases more than 0.5 mg / dL or eGFR decreases, more than 25% of contrast-enhanced nephropathy is considered. Intervention 2: Control group: In the control group, 45 minutes before angiography / angioplasty, inflating the 10 mm Hg pressure gauge cuff is performed less than systolic pressure in the elbow area with standard treatment. If creatinine increases more than 0.5 mg / dL or eGFR decreases, more than 25% of contrast-enhanced nephropathy is considered.</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 can be shared after people have not been identified.

When:
Immediately after the publication of the results.

To whom:
Researchers working in academic and scientific institutions.

Conditions:
Any analysis is allowed.

Where to obtain:
seyed shafi shafipoor
milad.shafipoor@gmail.com

How to obtain:
If the article is published, the data will be given as soon as possible after the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Shafi Shafipoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Shariati hospital, North Karegar Ave, Jalal-e-Al-e-Ahmad Hwy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 1000</telephone>
        <email>milad.shafipoor@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Abdolhossein Tabatabaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Shariati hospital, North Karegar Ave, Jalal-e-Al-e-Ahmad Hwy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 1000</telephone>
        <email>tabatabaeiseyedah@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Cr &gt; 1.4mg/dl or eGFR&lt; 60 cc/min
Informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>hemodialysis or Peritoneal dialysis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N99.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postprocedural (acute) (chronic) kidney failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, 45 minutes before angiography/angioplasty under induction ischemia with blood pressure cuff in the elbow area by inflating the cuff 50 mm Hg above systolic pressure in 5-minute for 4 cycles and 5-minute emptying between cycles with hydration. Standard treatment (hydration) is performed for all patients in the intervention and control group. If creatinine increases more than 0.5 mg / dL or eGFR decreases, more than 25% of contrast-enhanced nephropathy is considered.</i_keyword>
      <i_keyword>Control group: In the control group, 45 minutes before angiography / angioplasty, inflating the 10 mm Hg pressure gauge cuff is performed less than systolic pressure in the elbow area with standard treatment. If creatinine increases more than 0.5 mg / dL or eGFR decreases, more than 25% of contrast-enhanced nephropathy is considered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cratinine. Timepoint: Before the procedure and 48 hours after the procedure. Method of measurement: blood test: based on mg/dl.</prim_outcome>
      <prim_outcome>EGFR. Timepoint: Before the procedure and 48 hours after the procedure. Method of measurement: blood test: calculated by cockroft furmola.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-17</approval_date>
        <contact_name>Tehran university of medical sciences</contact_name>
        <contact_address>pour sina Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
