<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02258620</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB-SAR</org_study_id>
    <nct_id>NCT02258620</nct_id>
  </id_info>
  <brief_title>Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.</brief_title>
  <official_title>Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brugmann University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The radial approach for a coronary angiography is currently adopted by several centers&#xD;
      because of its simplicity. The radial artery spasm is the main inconvenient. Nitrates in&#xD;
      intra-arterial have been widely studied in prevention of this spasm. No studies have compared&#xD;
      the different routes of administration of nitrates as a patch and a continuous intravenous&#xD;
      injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The radial approach is favored for coronary angiography due of several advantages: reduction&#xD;
      of local bleeding risk, even in the most hemorragiparic situations, decreased downtime and&#xD;
      time reduction of hospitalization, improved patient ulterior comfort. However, this approach&#xD;
      is subject to an immediate major complication that is the radial artery spasm (RAS) which,&#xD;
      according to the criteria used, has an average incidence of 30%. The administration of a&#xD;
      vasodilator just before coronary angiography procedure enables an increase of the radial&#xD;
      artery diameter and thus a decrease of friction probes. Theoretically this prevents the&#xD;
      occurrence of the RAS.&#xD;
&#xD;
      The literature re-counts several vasodilator product tests (DN calcic blocker, magnesium&#xD;
      sulfate, alpha-adrenergic antagonist ...) and various routes of administration (direct&#xD;
      intravenous route (IV), subcutaneous injected route, direct intra-arterial route (IA)).&#xD;
      Overall intra-arterial DN appears to be more efficient. The downside is a brief, painful&#xD;
      thermal sensation but intense and notably unpleasant. IV injection is better tolerated but it&#xD;
      was a direct injection and without proof of its superiority over IA. The para-radial&#xD;
      subcutaneous injection has only been studied to facilitate access to the radial artery. The&#xD;
      investigators randomized study compares, for the first time, the effectiveness of the&#xD;
      transdermal administration of trinitrine (D) and continuous intravenous of dinitrate&#xD;
      isosorbide (V) to dinitrate isosorbide intraarterial (A) standard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radial artery diameter</measure>
    <time_frame>Day of administration</time_frame>
    <description>With the help of an arterial doppler, measure of the radial artery diameter after injection of dinitrate isosorbide at the beginning and at the end of the procedure (objective measure)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Probe friction</measure>
    <time_frame>Day of administration</time_frame>
    <description>Probe friction, as experienced by the operator (subjective measure)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>Day of administration</time_frame>
    <description>Pain felt by the patient in the forearm (subjective measure)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radial artery occlusion</measure>
    <time_frame>3 months post procedure</time_frame>
    <description>Evaluation of the radial artery occlusion 3 months post procedure</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">442</enrollment>
  <condition>Coronaropathy</condition>
  <arm_group>
    <arm_group_label>dinitrate isosorbide (intra venous)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dinitrate isosorbide by continuous intra venous injection (1 à 5 mg/h)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dinitrate isosorbide (intra arterial)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dinitrate isosorbide 5 mg by direct administration intra arterial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nitroglycerine (transdermic)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nitroglycerine dermal patch15 mg/24h soit 67,2 mg/21 cm2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dinitrate isosorbide</intervention_name>
    <description>dinitrate isosorbide (cedocard*) by continuous intra venous (1 to 5 mg/h) dinitrate isosorbide (cedocard*) 5 mg by intra arterial direct in the sheat</description>
    <arm_group_label>dinitrate isosorbide (intra arterial)</arm_group_label>
    <arm_group_label>dinitrate isosorbide (intra venous)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nitroglycerine</intervention_name>
    <description>nitroglycerine dermal patch 15 mg/24h : 67,2 mg/21 cm2</description>
    <arm_group_label>nitroglycerine (transdermic)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 ans.&#xD;
&#xD;
          -  Patients with hemodynamic stability.&#xD;
&#xD;
          -  Patients informed consent was signed by each individual. The study obtained approval&#xD;
             from the local ethics committee.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  'Test d'Allen' negative&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  STEMI&#xD;
&#xD;
          -  Hemodynamic Instability : PAS &lt; 100 mmHg, FC &gt; 100 bpm, tachycardia uncontrollable.&#xD;
&#xD;
          -  Allergy of nitrates.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>José Castro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU-Brugmann</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU-Brugmann</name>
      <address>
        <city>Bruxelles</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>October 3, 2014</last_update_submitted>
  <last_update_submitted_qc>October 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>José Castro</investigator_full_name>
    <investigator_title>Chef de Clinique</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Isosorbide</mesh_term>
    <mesh_term>Isosorbide Dinitrate</mesh_term>
    <mesh_term>Isosorbide-5-mononitrate</mesh_term>
    <mesh_term>Nitroglycerin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02258620
org study id: CHUB-SAR
nct id: NCT02258620
lead sponsor: 
has dmc: Yes
The radial approach for a coronary angiography is currently adopted by several centers
      because of its simplicity. The radial artery spasm is the main inconvenient. Nitrates in
      intra-arterial have been widely studied in prevention of this spasm. No studies have compared
      the different routes of administration of nitrates as a patch and a continuous intravenous
      injection.
The radial approach is favored for coronary angiography due of several advantages: reduction
      of local bleeding risk, even in the most hemorragiparic situations, decreased downtime and
      time reduction of hospitalization, improved patient ulterior comfort. However, this approach
      is subject to an immediate major complication that is the radial artery spasm (RAS) which,
      according to the criteria used, has an average incidence of 30%. The administration of a
      vasodilator just before coronary angiography procedure enables an increase of the radial
      artery diameter and thus a decrease of friction probes. Theoretically this prevents the
      occurrence of the RAS.

      The literature re-counts several vasodilator product tests (DN calcic blocker, magnesium
      sulfate, alpha-adrenergic antagonist ...) and various routes of administration (direct
      intravenous route (IV), subcutaneous injected route, direct intra-arterial route (IA)).
      Overall intra-arterial DN appears to be more efficient. The downside is a brief, painful
      thermal sensation but intense and notably unpleasant. IV injection is better tolerated but it
      was a direct injection and without proof of its superiority over IA. The para-radial
      subcutaneous injection has only been studied to facilitate access to the radial artery. The
      investigators randomized study compares, for the first time, the effectiveness of the
      transdermal administration of trinitrine (D) and continuous intravenous of dinitrate
      isosorbide (V) to dinitrate isosorbide intraarterial (A) standard.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Radial artery diameter
time frame: Day of administration
description: With the help of an arterial doppler, measure of the radial artery diameter after injection of dinitrate isosorbide at the beginning and at the end of the procedure (objective measure)
measure: Probe friction
time frame: Day of administration
description: Probe friction, as experienced by the operator (subjective measure)
measure: Pain
time frame: Day of administration
description: Pain felt by the patient in the forearm (subjective measure)
measure: Radial artery occlusion
time frame: 3 months post procedure
description: Evaluation of the radial artery occlusion 3 months post procedure
arm group label: dinitrate isosorbide (intra venous)
arm group type: Experimental
description: dinitrate isosorbide by continuous intra venous injection (1 à 5 mg/h)
arm group label: dinitrate isosorbide (intra arterial)
arm group type: Experimental
description: dinitrate isosorbide 5 mg by direct administration intra arterial
arm group label: nitroglycerine (transdermic)
arm group type: Experimental
description: nitroglycerine dermal patch15 mg/24h soit 67,2 mg/21 cm2
intervention type: Drug
intervention name: dinitrate isosorbide
description: dinitrate isosorbide (cedocard*) by continuous intra venous (1 to 5 mg/h) dinitrate isosorbide (cedocard*) 5 mg by intra arterial direct in the sheat
arm group label: dinitrate isosorbide (intra arterial)
arm group label: dinitrate isosorbide (intra venous)
intervention type: Drug
intervention name: nitroglycerine
description: nitroglycerine dermal patch 15 mg/24h : 67,2 mg/21 cm2
arm group label: nitroglycerine (transdermic)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: José Castro, MD
role: Principal Investigator
affiliation: CHU-Brugmann
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: José Castro
investigator title: Chef de Clinique
mesh term: Isosorbide
mesh term: Isosorbide Dinitrate
mesh term: Isosorbide-5-mononitrate
mesh term: Nitroglycerin