<?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>IRCT20160515027905N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-18</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>efficacy of  intravenous nitroglycerine infusion in the prevention of arterial spasm in transradial coronary angiography</public_title>
      <acronym></acronym>
      <scientific_title>Safety and efficacy of  intravenous nitroglycerine infusion in the prevention and control of arterial spasm in  transradial coronary angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22767</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized vote is a block random method, an individual randomization unit, so that at the beginning of each day, one of the patients with an angiographic candidate who had the criteria for entering the study was numbered and using the randomization table, Each patient was randomly assigned to either intervention or control group. To conceal, the placebo is used for the control group, Blinding description: In this study, for the control group, in addition to the routine activities, which included subcutaneous injection of lidocaine and nitroglycerin in the pancreter and the arterial nodule of nitroglycerin, 200 micrograms, nitroglycerin infusion was started 10 minutes before the pancreter, and in the control group, in addition to the routine measures In order to avoid the knowledge of the angiographic team, the intravenous infusion patient group starts a combination drug with an apparently similar appearance of nitroglycerin.</study_design>
      <phase>2</phase>
      <hc_freetext>coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, 10 minutes before the radial artery pancreas, nitroglycerin infusion began with a dose of 5 micrograms, and with control of blood pressure and disease of the patient up to 5 microns, based on the weight of the patientIn. the control group, a drug like nasal saline was used and minutes before the infusion of the drug in the control group begins. In this way, the operator will not know the patient in the group. Intervention 2: the control group, a drug like nasal saline was used and minutes before the infusion of the drug in the control group begins. In this way, the operator will not know the patient in the group.</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:
After completing the study, I will share the data in the article on valid seminars or journals

When:
1397

To whom:
Academic and academic institutions

Conditions:
Institutions that intend to develop science and carry out new research

Where to obtain:
Maleki farahnaz
f.maleki@rhc.ac.ir
00989123658518

How to obtain:
After contacting the mobile phone or sending an email within a week, I will send the documentation or files

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Ali Zahedmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasar street , Ejucational @ Reserch And Medical Rajaie Centerr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3175735664</zip>
        <telephone>+98 21239221108</telephone>
        <email>zahedmehr@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Zahedmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasar street ; Ejucational @ Reserch And Medical Rajaie Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3175735664</zip>
        <telephone>+98 21 2392 2108</telephone>
        <email>f.maleki@rhc.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Referral of the patient to the hospital for coronary artery angiography
Systolic blood pressure greater than 100 mm
Allen positive test
Awareness of the patient's time and space for measuring pain
Age older than 18 and less than 80 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to cooperate in the collection of information
Lack of proper access to radial artery
The drop in the blood pressure of the patient, which makes him inadequate in his hemodynamics
Loss of consciousness
Sensitization to nitroglycerine or similar compounds
Radial artery for angiography or other diagnostic treatments (vascular graft)
A history of vascular disease, such as Reynaud, which affects the artery stenosis
Use of oral pills containing nitroglycerin compounds in the last 4 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I51.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>cardiovascular disease NOS</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>In the intervention group, 10 minutes before the radial artery pancreas, nitroglycerin infusion began with a dose of 5 micrograms, and with control of blood pressure and disease of the patient up to 5 microns, based on the weight of the patientIn. the control group, a drug like nasal saline was used and minutes before the infusion of the drug in the control group begins. In this way, the operator will not know the patient in the group</i_keyword>
      <i_keyword>the control group, a drug like nasal saline was used and minutes before the infusion of the drug in the control group begins. In this way, the operator will not know the patient in the group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coronary artery spasm intensity during trans-radial angiography. Timepoint: Ten minutes before initiation of the angiographic procedure until the end of the coronary artery. Method of measurement: In order to measure patient pain in the pancreatic area and catheter pathway, a visual analogue scale is used and the gyre pressure gauge is used to check the effects of nitroglycerin.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient's pain and resistance to the passage of the wires and the catheter. Timepoint: The procedure time from the start of the pancreas to the end of the angiography. Method of measurement: Radar artery pancreatic time and during angiography.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-23</approval_date>
        <contact_name>Ethics Committee of Shaheed Rajaee Heart Therapy Research Center Tehran</contact_name>
        <contact_address>Valiasar street.Shaheed Rajaee Heart Therapy Research Center Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
