<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/NCT03789279</url>
  </required_header>
  <id_info>
    <org_study_id>18-WS-0182</org_study_id>
    <secondary_id>245250</secondary_id>
    <nct_id>NCT03789279</nct_id>
  </id_info>
  <brief_title>Observational Study of Hand Function After Distal Transradial Access for Angiography</brief_title>
  <acronym>RATATOUILLE</acronym>
  <official_title>RATATOUILLE Study (inteRnATional hAnd funcTiOn stUdy Following dIstaL radiaL accEss)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS National Waiting Times Centre Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MC Zuiderzee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS National Waiting Times Centre Board</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traditionally, coronary angiograms are performed through the radial artery which is accessed&#xD;
      above the palm of the 'right' hand. In recent years, some cardiologists are performing this&#xD;
      procedure from the back of the wrist in as the radial artery courses through the anatomical&#xD;
      snuffbox (distal radial access). The aim of this study is to determine the prevalence of hand&#xD;
      dysfunction following coronary angiography via the distal radial artery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this multi centre observational registry, we will recruit patients undergoing planned&#xD;
      invasive coronary angiography. Inclusion criteria include:&#xD;
&#xD;
        1. Age ≥ 18 years.&#xD;
&#xD;
        2. The distal radial artery must be palpable and non-occlusive flow must be confirmed by&#xD;
           Doppler ultrasound.&#xD;
&#xD;
        3. Patient should be able to comply with the protocol.&#xD;
&#xD;
        4. Provide written informed consent before study participation.&#xD;
&#xD;
      The primary endpoint is the overall prevalence of hand dysfunction defined as any significant&#xD;
      reduction from baseline score in any of the following five domains:&#xD;
&#xD;
      DASH score Levine Katz score VAS score Sensory function Pinch grip strength.&#xD;
&#xD;
      Specifically hand function will be assessed at 4 time points using simple tests of hand&#xD;
      strength, sensation and ultrasound to assess the arterial latency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Prevalence of hand dysfunction</measure>
    <time_frame>1 month</time_frame>
    <description>Any significant deterioration from baseline in hand function according to the 5 studied domains.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success of distal radial access</measure>
    <time_frame>Day 0</time_frame>
    <description>Successful introduction of sheath</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular access complications (other than occlusion and bleeding)</measure>
    <time_frame>Day 0</time_frame>
    <description>Surgical complications or clinically important vascular access complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Puncture time</measure>
    <time_frame>Day 0</time_frame>
    <description>Time from skin puncture to successful placement of wire into the artery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radial artery occlusion - including level of occlusion (prox/distal)</measure>
    <time_frame>0-12 months</time_frame>
    <description>USS guide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>Day 0</time_frame>
    <description>Minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemostasis duration</measure>
    <time_frame>Day 0</time_frame>
    <description>Minutes</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Radial Artery Occlusion</condition>
  <condition>Nerve Injury</condition>
  <arm_group>
    <arm_group_label>Distal transradial arterial access</arm_group_label>
    <description>Patients undergoing invasive coronary angiography via the distal radial approach (anatomical snuffbox)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible patients for inclusion are those by whom coronary angiography or angioplasty is&#xD;
        indicated as part of clinical decision-making or therapy. Operators with adequate&#xD;
        experience at the discretion of the principal investigator in distal radial access are&#xD;
        eligible to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years.&#xD;
&#xD;
          2. The distal radial artery must be palpable and non-occlusive flow must be confirmed by&#xD;
             Doppler ultrasound.&#xD;
&#xD;
          3. Patient should be able to comply with the protocol.&#xD;
&#xD;
          4. Provide written informed consent before study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Obligatory femoral or forearm radial access&#xD;
&#xD;
          2. Previous ipsilateral forearm radial artery occlusion.&#xD;
&#xD;
          3. Undergoing another procedure involving the ipsilateral radial artery, performed&#xD;
             between the index procedure and the follow-up date.&#xD;
&#xD;
          4. Enrolment in another study that competes or interferes with this study.&#xD;
&#xD;
          5. Poor clinical condition like cardiogenic shock, that prohibits pre- and postprocedural&#xD;
             function tests.&#xD;
&#xD;
          6. Any other condition which, in the opinion of the investigator or operator, may pose a&#xD;
             significant hazard to the subject if he or she is enrolled in the study.&#xD;
&#xD;
          7. Co-morbidity that excludes patient follow-up.&#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>Ferdinand Kiemeneij, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MC Zuiderzee</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed Hassan, MD</last_name>
    <role>Study Director</role>
    <affiliation>MC Zuiderzee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Glasgow/Golden Jubilee Research Foundation</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 8QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>March 7, 2021</last_update_submitted>
  <last_update_submitted_qc>March 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Glasgow</investigator_affiliation>
    <investigator_full_name>Dr Thomas J Ford</investigator_full_name>
    <investigator_title>Honorary Clinical Lecturer</investigator_title>
  </responsible_party>
  <keyword>Invasive coronary angiography</keyword>
  <keyword>Distal transradial arterial access</keyword>
  <keyword>Anatomical snuffbox</keyword>
  <keyword>dTRA</keyword>
  <keyword>dRA</keyword>
  <keyword>Distal radial</keyword>
  <keyword>Radial artery occlusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arterial Occlusive Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03789279
org study id: 18-WS-0182
secondary id: 245250
nct id: NCT03789279
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Traditionally, coronary angiograms are performed through the radial artery which is accessed
      above the palm of the 'right' hand. In recent years, some cardiologists are performing this
      procedure from the back of the wrist in as the radial artery courses through the anatomical
      snuffbox (distal radial access). The aim of this study is to determine the prevalence of hand
      dysfunction following coronary angiography via the distal radial artery.
In this multi centre observational registry, we will recruit patients undergoing planned
      invasive coronary angiography. Inclusion criteria include:

        1. Age ≥ 18 years.

        2. The distal radial artery must be palpable and non-occlusive flow must be confirmed by
           Doppler ultrasound.

        3. Patient should be able to comply with the protocol.

        4. Provide written informed consent before study participation.

      The primary endpoint is the overall prevalence of hand dysfunction defined as any significant
      reduction from baseline score in any of the following five domains:

      DASH score Levine Katz score VAS score Sensory function Pinch grip strength.

      Specifically hand function will be assessed at 4 time points using simple tests of hand
      strength, sensation and ultrasound to assess the arterial latency.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of hand dysfunction
time frame: 1 month
description: Any significant deterioration from baseline in hand function according to the 5 studied domains.
measure: Success of distal radial access
time frame: Day 0
description: Successful introduction of sheath
measure: Vascular access complications (other than occlusion and bleeding)
time frame: Day 0
description: Surgical complications or clinically important vascular access complications
measure: Puncture time
time frame: Day 0
description: Time from skin puncture to successful placement of wire into the artery
measure: Radial artery occlusion - including level of occlusion (prox/distal)
time frame: 0-12 months
description: USS guide
measure: Fluoroscopy time
time frame: Day 0
description: Minutes
measure: Hemostasis duration
time frame: Day 0
description: Minutes
arm group label: Distal transradial arterial access
description: Patients undergoing invasive coronary angiography via the distal radial approach (anatomical snuffbox)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ferdinand Kiemeneij, MD
role: Principal Investigator
affiliation: MC Zuiderzee
last name: Ahmed Hassan, MD
role: Study Director
affiliation: MC Zuiderzee
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Glasgow
investigator full name: Dr Thomas J Ford
investigator title: Honorary Clinical Lecturer
mesh term: Arterial Occlusive Diseases
sharing ipd: No