xml: <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/NCT06031077</url>
    </required_header>
    <id_info>
      <org_study_id>CEC1153/06/19</org_study_id>
      <nct_id>NCT06031077</nct_id>
    </id_info>
    <brief_title>Effectiveness and Safety of Distal Left Transradial Access in Coronary Procedures.</brief_title>
    <official_title>Effectiveness and Safety of Distal Left Transradial Access in Coronary Procedures.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of The West Indies</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of The West Indies</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>
        To evaluate the effectiveness and safety of distal left radial (dLR) access in coronary&#xD;
        procedures at a tertiary center in Trinidad and Tobago.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        An observational, retrospective study will be carried out. Roughly 111 patients were&#xD;
        registered at EWMSC and Cardiac Angiograms were done via approached through the left radial&#xD;
        access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms&#xD;
        were also done via the anatomical snuff box. This study seeks to compare the results of&#xD;
        Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Actual">August 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Comparison of snuff box access to radial access for coronary angiography in Trinidad and Tobago.</measure>
      <time_frame>roughly 3 years</time_frame>
      <description>An observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">150</enrollment>
    <condition>Cardiovascular Diseases</condition>
    <condition>Cardiomyopathies</condition>
    <arm_group>
      <arm_group_label>Cardiologist Assessed Conditions.</arm_group_label>
      <description>The consultant Cardiologist will decide on the various types of presentations and symptoms that will be use full in generating this study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>cardiac catheterization</intervention_name>
      <description>An observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.</description>
      <arm_group_label>Cardiologist Assessed Conditions.</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Caribbean decent population of Trinidad and Tobago.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Cardiologist recommended guidelines.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Eric Williams Medical Sciences Complex</name>
        <address>
          <city>Port Of Spain</city>
          <state>North Central</state>
          <zip>00000</zip>
          <country>Trinidad and Tobago</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Trinidad and Tobago</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of The West Indies</investigator_affiliation>
      <investigator_full_name>Naveen Seecheran</investigator_full_name>
      <investigator_title>Dr. Naveen Anand Seecheran</investigator_title>
    </responsible_party>
    <keyword>Distal Radial Artery Angiogram</keyword>
    <keyword>Anatomical Snuff Box Angiogram</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Cardiomyopathies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The principal reason for this study is to aid physicians with the necessary data to perform cardiac catherisation and to show them different access points.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031077
  org study id: CEC1153/06/19
  nct id: NCT06031077
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the effectiveness and safety of distal left radial (dLR) access in coronary
        procedures at a tertiary center in Trinidad and Tobago.
  An observational, retrospective study will be carried out. Roughly 111 patients were
        registered at EWMSC and Cardiac Angiograms were done via approached through the left radial
        access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms
        were also done via the anatomical snuff box. This study seeks to compare the results of
        Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.
  observational model: Other
  time perspective: Retrospective
  measure: Comparison of snuff box access to radial access for coronary angiography in Trinidad and Tobago.
  time frame: roughly 3 years
  description: An observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.
  arm group label: Cardiologist Assessed Conditions.
  description: The consultant Cardiologist will decide on the various types of presentations and symptoms that will be use full in generating this study.
  intervention type: Procedure
  intervention name: cardiac catheterization
  description: An observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.
  arm group label: Cardiologist Assessed Conditions.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  country: Trinidad and Tobago
  responsible party type: Principal Investigator
  investigator affiliation: The University of The West Indies
  investigator full name: Naveen Seecheran
  investigator title: Dr. Naveen Anand Seecheran
  mesh term: Cardiovascular Diseases
  mesh term: Cardiomyopathies
  sharing ipd: No
  ipd description: The principal reason for this study is to aid physicians with the necessary data to perform cardiac catherisation and to show them different access points.