<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/NCT03272451</url>
  </required_header>
  <id_info>
    <org_study_id>BeijingLH</org_study_id>
    <nct_id>NCT03272451</nct_id>
  </id_info>
  <brief_title>ECG-guided Immediate Primary PCI for Culprit Vessel to Reduce Door to Device Time</brief_title>
  <official_title>ECG-guided Immediate pRimAry Percutaneous Coronary Intervention for Culprit Vessel Using a Transradial Single Guiding Catheter to Reduce Door to Device Time: RAPID II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Luhe Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Luhe Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      No consensus exists about which coronary artery should be firstly catheterized in primary&#xD;
      percutaneous coronary intervention (PCI). The aim of the present study was to compare&#xD;
      door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with&#xD;
      traditional complete coronary angiography followed by PCI for the treatment of ST segment&#xD;
      elevation myocardial infarction (STEMI) patients. Primary endpoint is door to device (D2D)&#xD;
      time. Secondary end-points are: puncture to device (P2D) time,first medical contact to device&#xD;
      (FMC2D) time,incidence of radial artery spasm and occlusion, contrast amount, fluoroscopy&#xD;
      time, cumulative air kerma(CAK) and dose area product(DAP).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 15, 2019</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>door to device (D2D) time</measure>
    <time_frame>24hours</time_frame>
    <description>time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>puncture to device (P2D) time</measure>
    <time_frame>24hours</time_frame>
    <description>time from radail artery puncture to first device(balloon,aspiration catheter or stent) use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>first medical contact to device (FMC2D) time</measure>
    <time_frame>24hours</time_frame>
    <description>time from first medical contact to first device (balloon,aspiration catheter or stent) use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of radial artery spasm</measure>
    <time_frame>during the procedure (time from the guide catheter inserted to guide catheter removed)</time_frame>
    <description>radial artery spasms were defined as follows. Severe, moderate, and mild based on radiao angiography before and after procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of radial artery occlusion</measure>
    <time_frame>inhospital (an expected average of 5 days),30day,12month</time_frame>
    <description>the absence of palpable radial artery pulsation confirmed by echocardiogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fluoroscopy time</measure>
    <time_frame>1 hour</time_frame>
    <description>recorded on the machine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative air kerma(CAK) and dose area product(DAP).</measure>
    <time_frame>1 hour</time_frame>
    <description>recorded on the machine</description>
  </secondary_outcome>
  <other_outcome>
    <measure>MACE</measure>
    <time_frame>12 month</time_frame>
    <description>major advance cardiac event (MACE)including cardiacdeath, myocardial infarction (MI) and target vessel revascularization (TVR)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">560</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>culprit vessel intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>culprit vessel PCI prior to contralateral angiography using a single transradial guiding catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>complete coronary angiography followed by guiding catheter selection for culprit vessel PCI</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>culprit vessel intervention</intervention_name>
    <description>ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5</description>
    <arm_group_label>culprit vessel intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>traditional approach</intervention_name>
    <description>single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI</description>
    <arm_group_label>traditional approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must be &gt; 18 years of age&#xD;
&#xD;
          -  Patients have typical chest pain for at least 20 minutes and have ECG changes typical&#xD;
             for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in&#xD;
             two limb leads or new left bundle branch block) or ECG changes compatible with true&#xD;
             posterior MI&#xD;
&#xD;
          -  Symptoms ≥ 30 min and ≤12 hours&#xD;
&#xD;
          -  Patient and treating interventional cardiologist agree for randomization&#xD;
&#xD;
          -  Patient provides written informed consent&#xD;
&#xD;
          -  Diagnostic and therapeutic intervention performed through transradial artery approach&#xD;
&#xD;
          -  Palpable radial artery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent participation in other investigational study&#xD;
&#xD;
          -  Current platelet count &lt;100 x 10^9cells/L or Hgb &lt;10 g/dL&#xD;
&#xD;
          -  Absence of radial artery pulsation&#xD;
&#xD;
          -  Active bleeding or significant increased risk of bleeding, severe hepatic&#xD;
             insufficiency, current peptic ulceration, proliferative diabetic retinopathy&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Prior CABG surgery&#xD;
&#xD;
          -  Fibrinolytic therapy for current MI treatment&#xD;
&#xD;
          -  patient have a life expectancy of &lt;180days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Luhe hospital</name>
      <address>
        <city>Beijing</city>
        <zip>101149</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Luhe hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>May 31, 2022</last_update_submitted>
  <last_update_submitted_qc>May 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03272451
org study id: BeijingLH
nct id: NCT03272451
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
No consensus exists about which coronary artery should be firstly catheterized in primary
      percutaneous coronary intervention (PCI). The aim of the present study was to compare
      door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with
      traditional complete coronary angiography followed by PCI for the treatment of ST segment
      elevation myocardial infarction (STEMI) patients. Primary endpoint is door to device (D2D)
      time. Secondary end-points are: puncture to device (P2D) time,first medical contact to device
      (FMC2D) time,incidence of radial artery spasm and occlusion, contrast amount, fluoroscopy
      time, cumulative air kerma(CAK) and dose area product(DAP).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: door to device (D2D) time
time frame: 24hours
description: time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use
measure: puncture to device (P2D) time
time frame: 24hours
description: time from radail artery puncture to first device(balloon,aspiration catheter or stent) use
measure: first medical contact to device (FMC2D) time
time frame: 24hours
description: time from first medical contact to first device (balloon,aspiration catheter or stent) use.
measure: incidence of radial artery spasm
time frame: during the procedure (time from the guide catheter inserted to guide catheter removed)
description: radial artery spasms were defined as follows. Severe, moderate, and mild based on radiao angiography before and after procedure
measure: incidence of radial artery occlusion
time frame: inhospital (an expected average of 5 days),30day,12month
description: the absence of palpable radial artery pulsation confirmed by echocardiogram
measure: fluoroscopy time
time frame: 1 hour
description: recorded on the machine
measure: cumulative air kerma(CAK) and dose area product(DAP).
time frame: 1 hour
description: recorded on the machine
measure: MACE
time frame: 12 month
description: major advance cardiac event (MACE)including cardiacdeath, myocardial infarction (MI) and target vessel revascularization (TVR)
arm group label: culprit vessel intervention
arm group type: Experimental
description: culprit vessel PCI prior to contralateral angiography using a single transradial guiding catheter
arm group label: traditional approach
arm group type: Active Comparator
description: complete coronary angiography followed by guiding catheter selection for culprit vessel PCI
intervention type: Procedure
intervention name: culprit vessel intervention
description: ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5
arm group label: culprit vessel intervention
intervention type: Procedure
intervention name: traditional approach
description: single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI
arm group label: traditional approach
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction