<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/NCT02204423</url>
  </required_header>
  <id_info>
    <org_study_id>NL45613.101.13</org_study_id>
    <nct_id>NCT02204423</nct_id>
  </id_info>
  <brief_title>Upper Extremity Dysfunction Post Radial Percutaneous Coronary Intervention</brief_title>
  <official_title>Upper Extremity Dysfunction Post Radial PCI: A Cohort Study Evaluating Upper Extremity Dysfunction After Percutaneous Coronary Intervention Using the Radial Artery as Access Route</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Schweitzer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albert Schweitzer Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trans-Radial Percutaneous Coronary Intervention (TR-PCI) is rapidly becoming the gold&#xD;
      standard. This is especially the case in primary Percutaneous Coronary Interventions (PCI),&#xD;
      where most benefits of the radial approach, such as reduced major bleeding and mortality, can&#xD;
      be expected. However there is very limited research available looking at the consequences of&#xD;
      trans-radial access for upper extremity function.&#xD;
&#xD;
      The main objective of this study is to provide insight in the morbidity with regards to the&#xD;
      upper extremity surrounding the radial access route in percutaneous coronary interventions.&#xD;
      Secondary objectives are to provide insight in the consequences for functional status,&#xD;
      factors influencing and financial costs of this morbidity, to identify subject who might&#xD;
      benefit from early referral and treatment of this morbidity and to generate hypotheses for&#xD;
      further clinical research into this matter.&#xD;
&#xD;
      The investigators hypothesis is that approximately 20% of the population will experience&#xD;
      upper extremity dysfunction after TR-PCI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A binary score of upper extremity dysfunction</measure>
    <time_frame>2 weeks</time_frame>
    <description>A positive score is defined as the presence of at least a ≥1 point increase in the Levine-Katz (Boston) questionnaire; or at least 2 of the following decreased scores compared to baseline, 2 weeks after TR-PCI:&#xD;
≥15% decrease in the DASH-outcome measure.&#xD;
Increase in VAS pain score with regard to the upper extremity of ≥2 points&#xD;
Absent signal of the radial artery using Doppler&#xD;
10% decrease in goniometry of the upper extremity, with a minimum decrease of 10 degree Strength&#xD;
60N decrease in palmar grip strength&#xD;
12N decrease in pinch grip strength&#xD;
15% decrease in isometric strength of the following manoeuvres:&#xD;
Flexion and extension of the elbow and/or wrist&#xD;
Sensibility loss of ≥1 filament of the hand using Semmes-Weinstein filaments according to WEST&#xD;
1cm increase at volumetry of the hand, using the Figure of 8-method&#xD;
1cm increase at volumetry of the forearm, measured circumferentially 8 cm distal of the medial epicondyle&#xD;
Compartment syndrome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Successful arterial access</measure>
    <time_frame>During procedure</time_frame>
    <description>Successful arterial access of the target radial artery, defined as the ability to successfully advance a guiding catheter and position it in the coronary ostium.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cross-over</measure>
    <time_frame>During procedure</time_frame>
    <description>Percentage of cross-over from radial to femoral access</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anomaly</measure>
    <time_frame>During procedure</time_frame>
    <description>Presence of branching anomaly (high radial artery take-off), tortuosity (none, mild, moderate or severe), stenosis (not encountered or percentage of stenosis encountered) and/or spasm (none, mild, moderate or severe) of the radial artery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Access route complications</measure>
    <time_frame>6 months</time_frame>
    <description>Access route complications, dissection or perforation of radial, brachial or subclavian artery, as evidenced by angiography or computed tomography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success</measure>
    <time_frame>During procedure</time_frame>
    <description>Procedural success (defined as &lt;30% residual stenosis at the end of the procedure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheter performance</measure>
    <time_frame>During procedure</time_frame>
    <description>Overall catheter performance ranging from 0 (very bad) - 5 (very good)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>During procedure</time_frame>
    <description>Procedure time in minutes, from guide catheter insertion to withdrawal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation</measure>
    <time_frame>During procedure</time_frame>
    <description>Radiation time and dose, in minutes and mGy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACCE</measure>
    <time_frame>6 months</time_frame>
    <description>Major adverse cardiac and cerebrovascular events (MACCE), defined as:&#xD;
Myocardial infarction (MI), according to the Third Universal definition of Myocardial Infarction&#xD;
Target vessel revascularisation, either by PCI or surgical&#xD;
Death&#xD;
Cerebrovascular accident (CVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>6 months</time_frame>
    <description>Bleeding events (according to Academic Research Consortium definitions) at procedure and at each consecutive follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DASH</measure>
    <time_frame>6 months</time_frame>
    <description>&quot;Disabilities of the Arm, Shoulder and Hand&quot; (DASH) outcome measured at two weeks, one and six months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS</measure>
    <time_frame>6 months</time_frame>
    <description>Visual Analogue Scale pain score (VAS) with regard to the upper extremity at one day, two weeks, one and six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occlusion</measure>
    <time_frame>6 months</time_frame>
    <description>Presence or absence of arterial pulse when evaluating the radial artery using Doppler ultrasound examination extremity at one day, two weeks, one and six months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AROM</measure>
    <time_frame>6 months</time_frame>
    <description>Active Range Of Motion (AROM) goniometry values in degrees of the upper extremity at two weeks, one and six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength</measure>
    <time_frame>6 months</time_frame>
    <description>o Strength in Newton at two weeks, one and six months:&#xD;
Palmar grip strength&#xD;
Pinch grip strength&#xD;
Isometric strength of the following manoeuvres:&#xD;
Flexion and extension of the elbow&#xD;
Flexion and extension of the wrist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensibility</measure>
    <time_frame>6 months</time_frame>
    <description>Sensibility of the hand using Semmes-Weinstein filaments according to WEST at two weeks, one and six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volumetry of the hand</measure>
    <time_frame>6 months</time_frame>
    <description>Volumetry of the hand in centimeters using the Figure of eight-method extremity at one day, two weeks, one and six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volumetry of the forearm</measure>
    <time_frame>6 months</time_frame>
    <description>Volumetry of the forearm in centimetres at one day, two weeks, one and six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levine-Katz (Boston) questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Symptom-severity score and the functional-status score of the Levine-Katz (Boston) questionnaire at two weeks, one and six months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hand centre</measure>
    <time_frame>After reaching primary endpoint</time_frame>
    <description>o If the primary endpoint has been reached:&#xD;
Diagnostic procedures performed at the hand centre&#xD;
Diagnosis of the hand centre&#xD;
Performed treatment at the hand centre&#xD;
Upper extremity related absence of work in days</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Upper Extremity Dysfunction</condition>
  <arm_group>
    <arm_group_label>Trans-Radial PCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trans-Radial Percutaneous Coronary Intervention (TR-PCI)</intervention_name>
    <arm_group_label>Trans-Radial PCI</arm_group_label>
    <other_name>Dotter-Procedure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presenting for TR-PCI at the study centre.&#xD;
&#xD;
          -  The radial artery can be palpated and Doppler ultrasound examination of the radial&#xD;
             artery shows non-occlusive flow.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in another study that clinically interferes with this study and&#xD;
             that has not passed the primary endpoint.&#xD;
&#xD;
          -  The clinical condition prohibits or hinders informed consent and/or baseline&#xD;
             examinations. E.g. cardiogenic shock and cardiopulmonary resuscitation or subconscious&#xD;
             and semiconscious state,.&#xD;
&#xD;
          -  Co-morbid condition(s) that could limit the subject's ability to participate in the&#xD;
             study or to comply with follow-up requirements, or impact the scientific integrity of&#xD;
             the study, e.g. loss of voluntary motor control of the studied extremities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sander IJsselmuiden, MD, PHD</last_name>
    <phone>+31-78-6542039</phone>
    <email>s.ijsselmuiden@asz.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Roos Koopman, MD</last_name>
    <phone>+31-78-6550594</phone>
    <email>A.g.m.koopman@asz.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Albert Schweitzer Hospital</name>
      <address>
        <city>Dordrecht</city>
        <state>Zuid-Holland</state>
        <zip>3318 AT</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roos Koopman, MD</last_name>
      <phone>+31-78-6550594</phone>
      <email>a.g.m.koopman@asz.nl</email>
    </contact>
    <contact_backup>
      <last_name>Sander IJsselmuiden, MD, PHD</last_name>
      <phone>+31-78-6542039</phone>
      <email>s.ijsselmuiden@asz.nl</email>
    </contact_backup>
    <investigator>
      <last_name>Sander IJsselmuiden, MD, PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carlo Holtzer, MD, PHD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roos Koopman, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Schweitzer Hospital</investigator_affiliation>
    <investigator_full_name>Anna Koopman</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Upper extremity dysfunction</keyword>
  <keyword>Trans-Radial Percutaneous Coronary Interventions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_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/NCT02204423
org study id: NL45613.101.13
nct id: NCT02204423
lead sponsor: 
has dmc: Yes
Trans-Radial Percutaneous Coronary Intervention (TR-PCI) is rapidly becoming the gold
      standard. This is especially the case in primary Percutaneous Coronary Interventions (PCI),
      where most benefits of the radial approach, such as reduced major bleeding and mortality, can
      be expected. However there is very limited research available looking at the consequences of
      trans-radial access for upper extremity function.

      The main objective of this study is to provide insight in the morbidity with regards to the
      upper extremity surrounding the radial access route in percutaneous coronary interventions.
      Secondary objectives are to provide insight in the consequences for functional status,
      factors influencing and financial costs of this morbidity, to identify subject who might
      benefit from early referral and treatment of this morbidity and to generate hypotheses for
      further clinical research into this matter.

      The investigators hypothesis is that approximately 20% of the population will experience
      upper extremity dysfunction after TR-PCI.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: A binary score of upper extremity dysfunction
time frame: 2 weeks
description: A positive score is defined as the presence of at least a ≥1 point increase in the Levine-Katz (Boston) questionnaire; or at least 2 of the following decreased scores compared to baseline, 2 weeks after TR-PCI:
≥15% decrease in the DASH-outcome measure.
Increase in VAS pain score with regard to the upper extremity of ≥2 points
Absent signal of the radial artery using Doppler
10% decrease in goniometry of the upper extremity, with a minimum decrease of 10 degree Strength
60N decrease in palmar grip strength
12N decrease in pinch grip strength
15% decrease in isometric strength of the following manoeuvres:
Flexion and extension of the elbow and/or wrist
Sensibility loss of ≥1 filament of the hand using Semmes-Weinstein filaments according to WEST
1cm increase at volumetry of the hand, using the Figure of 8-method
1cm increase at volumetry of the forearm, measured circumferentially 8 cm distal of the medial epicondyle
Compartment syndrome
measure: Successful arterial access
time frame: During procedure
description: Successful arterial access of the target radial artery, defined as the ability to successfully advance a guiding catheter and position it in the coronary ostium.
measure: Cross-over
time frame: During procedure
description: Percentage of cross-over from radial to femoral access
measure: Anomaly
time frame: During procedure
description: Presence of branching anomaly (high radial artery take-off), tortuosity (none, mild, moderate or severe), stenosis (not encountered or percentage of stenosis encountered) and/or spasm (none, mild, moderate or severe) of the radial artery
measure: Access route complications
time frame: 6 months
description: Access route complications, dissection or perforation of radial, brachial or subclavian artery, as evidenced by angiography or computed tomography
measure: Procedural success
time frame: During procedure
description: Procedural success (defined as <30% residual stenosis at the end of the procedure)
measure: Catheter performance
time frame: During procedure
description: Overall catheter performance ranging from 0 (very bad) - 5 (very good)
measure: Procedure time
time frame: During procedure
description: Procedure time in minutes, from guide catheter insertion to withdrawal
measure: Radiation
time frame: During procedure
description: Radiation time and dose, in minutes and mGy
measure: MACCE
time frame: 6 months
description: Major adverse cardiac and cerebrovascular events (MACCE), defined as:
Myocardial infarction (MI), according to the Third Universal definition of Myocardial Infarction
Target vessel revascularisation, either by PCI or surgical
Death
Cerebrovascular accident (CVA)
measure: Bleeding
time frame: 6 months
description: Bleeding events (according to Academic Research Consortium definitions) at procedure and at each consecutive follow-up
measure: DASH
time frame: 6 months
description: "Disabilities of the Arm, Shoulder and Hand" (DASH) outcome measured at two weeks, one and six months
measure: VAS
time frame: 6 months
description: Visual Analogue Scale pain score (VAS) with regard to the upper extremity at one day, two weeks, one and six months.
measure: Occlusion
time frame: 6 months
description: Presence or absence of arterial pulse when evaluating the radial artery using Doppler ultrasound examination extremity at one day, two weeks, one and six months
measure: AROM
time frame: 6 months
description: Active Range Of Motion (AROM) goniometry values in degrees of the upper extremity at two weeks, one and six months.
measure: Strength
time frame: 6 months
description: o Strength in Newton at two weeks, one and six months:
Palmar grip strength
Pinch grip strength
Isometric strength of the following manoeuvres:
Flexion and extension of the elbow
Flexion and extension of the wrist
measure: Sensibility
time frame: 6 months
description: Sensibility of the hand using Semmes-Weinstein filaments according to WEST at two weeks, one and six months.
measure: Volumetry of the hand
time frame: 6 months
description: Volumetry of the hand in centimeters using the Figure of eight-method extremity at one day, two weeks, one and six months.
measure: Volumetry of the forearm
time frame: 6 months
description: Volumetry of the forearm in centimetres at one day, two weeks, one and six months.
measure: Levine-Katz (Boston) questionnaire
time frame: 6 months
description: Symptom-severity score and the functional-status score of the Levine-Katz (Boston) questionnaire at two weeks, one and six months
measure: Hand centre
time frame: After reaching primary endpoint
description: o If the primary endpoint has been reached:
Diagnostic procedures performed at the hand centre
Diagnosis of the hand centre
Performed treatment at the hand centre
Upper extremity related absence of work in days
arm group label: Trans-Radial PCI
arm group type: Experimental
intervention type: Procedure
intervention name: Trans-Radial Percutaneous Coronary Intervention (TR-PCI)
arm group label: Trans-Radial PCI
other name: Dotter-Procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sander IJsselmuiden, MD, PHD
phone: +31-78-6542039
email: s.ijsselmuiden@asz.nl
last name: Roos Koopman, MD
phone: +31-78-6550594
email: A.g.m.koopman@asz.nl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Albert Schweitzer Hospital
investigator full name: Anna Koopman
investigator title: MD
mesh term: Musculoskeletal Diseases