<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/NCT02239757</url>
  </required_header>
  <id_info>
    <org_study_id>LERRASMI</org_study_id>
    <secondary_id>Lerrasmi</secondary_id>
    <nct_id>NCT02239757</nct_id>
  </id_info>
  <brief_title>Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly&#xD;
      related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion&#xD;
      time has not been fully studied for SETMI patients undergoing primary percutaneous coronary&#xD;
      intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety&#xD;
      of left radial approach for primary PCI in STEMI patients compared with right radial&#xD;
      approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will enroll consecutively for 3 years all STEMI patients undergoing primary&#xD;
      PCI.&#xD;
&#xD;
      Patients will be included within 12 hours of symptom onset for primary PCI. Patients will be&#xD;
      excluded if they are in cardiogenic shock.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Needle to balloon time</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiation dose</measure>
    <time_frame>7 days</time_frame>
    <description>Radiation dose include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast volume</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Vascular complications</measure>
    <time_frame>7 days</time_frame>
    <description>Vascular complications include pseudoaneurysm, arteriovenous fistula, lose of radial artery pulse, puncture site bleeding and forearm hematoma.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Right radial approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Primary PCI performed through right radial approach.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Left radial approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Primary PCI performed through left radial approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Left radial approach</intervention_name>
    <description>Primary PCI performed through left radial approach.</description>
    <arm_group_label>Right radial approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Right radial approach</intervention_name>
    <description>Primary PCI performed through right radial approach.</description>
    <arm_group_label>Left radial approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All consecutive patients with ST-segment elevation myocardial infarction within 12 hours of&#xD;
        symptom onset for primary PCI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients are excluded if they were in cardiogenic shock.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Buxing Chen, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tiantan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital, Capital Medical University</name>
      <address>
        <city>Beijing,</city>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Hu H, Fu Q, Chen W, Wang D, Hua X, Chen B. A prospective randomized comparison of left and right radial approach for percutaneous coronary angiography in Asian populations. Clin Interv Aging. 2014 Jun 20;9:963-8. doi: 10.2147/CIA.S64235. eCollection 2014.</citation>
    <PMID>25018624</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>July 30, 2015</last_update_submitted>
  <last_update_submitted_qc>July 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Buxing Chen</investigator_full_name>
    <investigator_title>Director of department of cardiology</investigator_title>
  </responsible_party>
  <keyword>Transradial Approach, Primary PCI, ST-segment elevation myocardial infarction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT02239757
org study id: LERRASMI
secondary id: Lerrasmi
nct id: NCT02239757
lead sponsor: 
has dmc: Yes
Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly
      related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion
      time has not been fully studied for SETMI patients undergoing primary percutaneous coronary
      intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety
      of left radial approach for primary PCI in STEMI patients compared with right radial
      approach.
The investigators will enroll consecutively for 3 years all STEMI patients undergoing primary
      PCI.

      Patients will be included within 12 hours of symptom onset for primary PCI. Patients will be
      excluded if they are in cardiogenic shock.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Needle to balloon time
time frame: 1 day
measure: Radiation dose
time frame: 7 days
description: Radiation dose include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)
measure: Fluoroscopy time
time frame: 7 days
measure: Contrast volume
time frame: 7 days
measure: Vascular complications
time frame: 7 days
description: Vascular complications include pseudoaneurysm, arteriovenous fistula, lose of radial artery pulse, puncture site bleeding and forearm hematoma.
arm group label: Right radial approach
arm group type: Experimental
description: Primary PCI performed through right radial approach.
arm group label: Left radial approach
arm group type: Experimental
description: Primary PCI performed through left radial approach.
intervention type: Procedure
intervention name: Left radial approach
description: Primary PCI performed through left radial approach.
arm group label: Right radial approach
intervention type: Procedure
intervention name: Right radial approach
description: Primary PCI performed through right radial approach.
arm group label: Left radial approach
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Buxing Chen, MD, Ph.D
role: Principal Investigator
affiliation: Beijing Tiantan Hospital
facility: 
country: China
citation: Hu H, Fu Q, Chen W, Wang D, Hua X, Chen B. A prospective randomized comparison of left and right radial approach for percutaneous coronary angiography in Asian populations. Clin Interv Aging. 2014 Jun 20;9:963-8. doi: 10.2147/CIA.S64235. eCollection 2014.
PMID: 25018624
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Buxing Chen
investigator title: Director of department of cardiology
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction