<?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>IRCT20081019001369N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-14</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Preventive Effect of Intravenous Trans Sodium Crocetinate on Contrast-Induced Nephropathy</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Preventive Effect of Intravenous Trans Sodium Crocetinate on Contrast-Induced Nephropathy in Patients Undergoing Coronary Angioplasty : A randomized placebo-controlled triple-blind clinical trail</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>152</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61889</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: block randomization complete by using www.randomization.com. each block has 4 members defining as [AABB], [ABAB], [ABBA], [BABA], [BBAA], [BAAB]. Codes A and B are randomly assigned to the intervention groups and the control group. The aforementioned site selects 38 blocks at random from the four blocks so that 76 patients can be included in the study. patients will be assigned to one of the control groups according to the time of admission and at the beginning of admission according to the sequence obtained in the randomization stage. Interventions are allocated. These codes are not provided to the researcher present in the physician's office. Medications are also given to patient by number (A or B) and he is completely unaware of which drug or placebo is. The researcher's telephone number is also available for patients to call whenever any problem arises. (This researcher is not involved in prescribing or analyzing the data; however, he or she is solely responsible for evaluating and maintaining the codes and providing medication to patients based on a random code determined by the physician). The code assigned by him is recorded in the CRF form, Blinding description: After the codes are prepared and given to the researcher, if the inclusion criteria are met and based on the codes, the patient is randomly placed in one of the groups. The relevant code is recorded in the CRF form and the researcher considers the drug or placebo based on the assigned code for the patient. After the patient is admitted to the hospital, the patient is introduced to a nurse and the medication is prescribed by the nurse (therapist). Knows only the assigned code, performs the relevant evaluations, and after registration, the results are given to the person who performs the data analysis, in the form of a code, and the data analysis is performed without the knowledge of the data analyzer. And all confidential information is recorded and stored without mentioning the patient's name. The vials of medicine and placebo, as well as the pills taken, have a similar shape.</study_design>
      <phase>2</phase>
      <hc_freetext>Certain current complications following acute myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients undergoing elective angioplasty who, in addition to the standard preventive measure of CIN, recieve TSC at dose of 0.5 mg / kg as an injection, 5 minutes before angioplasty, and then on days 0 to 5 of the patient intervention in the form of oral tablets of crocetin 7.5 mg daily 3 tablets for 5 days. Intervention 2: Control group: Patients undergoing elective angioplasty who, in addition to the standard preventive measure of CIN , placebo vial containing normal saline They receive 0.9% at a dose of 0.5 mg / kg by injection 5 minutes before angioplasty, and then on days 0 to 5 of the intervention, the patient takes oral placebo tablets for 5 days, 3 tablets daily.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>arash gholoobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Blv. ebne sina.  Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran, 1365-91775</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948954</zip>
        <telephone>+98 51 3180 1193</telephone>
        <email>gholoobiA@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>AmirHoushang Mohamadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Blv. Vakilabad2-School of Pharmacy, 1365-91775</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948954</zip>
        <telephone>+98 51 3180 1193</telephone>
        <email>mohaamadpoorah@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidates for outpatient angioplasty</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of ESRD requires dialysis before angiography
Presence of underlying diseases leading to acute renal failure regardless of contrast-induced acute renal failure
Existence of active tumor
History of exposure to intravenous contrast agents in the last 14 days for other reasons
Existence of heart failure or cardiogenic shock
Taking drugs interacting kidney function</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I23</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Certain current complications following ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction (within the 28 day period)</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 undergoing elective angioplasty who, in addition to the standard preventive measure of CIN, recieve TSC at dose of 0.5 mg / kg as an injection, 5 minutes before angioplasty, and then on days 0 to 5 of the patient intervention in the form of oral tablets of crocetin 7.5 mg daily 3 tablets for 5 days</i_keyword>
      <i_keyword>Control group: Patients undergoing elective angioplasty who, in addition to the standard preventive measure of CIN , placebo vial containing normal saline They receive 0.9% at a dose of 0.5 mg / kg by injection 5 minutes before angioplasty, and then on days 0 to 5 of the intervention, the patient takes oral placebo tablets for 5 days, 3 tablets daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Effect of TSC on the occurrence of acute kidney injury. Timepoint: during 5 days. Method of measurement: mehran score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Effect of TSC administration on creatinine clearance level. Timepoint: days 0 , 1 , 2 ,5. Method of measurement: laboratory evaluation.</sec_outcome>
      <sec_outcome>Effect of TSC administration on serum creatinine and BUN level. Timepoint: days 0 , 1 , 2 ,5. Method of measurement: laboratory evaluation.</sec_outcome>
      <sec_outcome>Effect of TSC administration on cystatin C level. Timepoint: days 0 , 1 , 2. Method of measurement: laboratory evaluation.</sec_outcome>
      <sec_outcome>Effect of TSC administration on  hs-CRP level. Timepoint: days 0 , 5. Method of measurement: laboratory evaluation.</sec_outcome>
      <sec_outcome>Effect of TSC administration on 24hours urine analysis test. Timepoint: days 0 , 1 , 2 ,5. Method of measurement: laboratory evaluation.</sec_outcome>
      <sec_outcome>Effect of TSC administration on mehran score. Timepoint: days 0 , 5. Method of measurement: laboratory evaluation.</sec_outcome>
      <sec_outcome>Effect of TSC administration on MDA test. Timepoint: days 0 , 5. Method of measurement: laboratory evaluation.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-01</approval_date>
        <contact_name>کمیته منطقه ای اخلاق دانشگاه علوم پزشکی مشهد</contact_name>
        <contact_address>Blv.Vakilabad 2- School of Pharmacy-1365-91775 mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
