<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/NCT03789344</url>
  </required_header>
  <id_info>
    <org_study_id>301FW</org_study_id>
    <nct_id>NCT03789344</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI</brief_title>
  <official_title>Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huan Wang, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General 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>
      Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in&#xD;
      Patients Treated with PCI&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 1, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Heart Rate Variability at 7 days</measure>
    <time_frame>at 1day before and 7 days after percutaneous coronary intervention</time_frame>
    <description>The primary efficacy variable was the heart rate variability of patients accepted the PCI treatment between control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scores of HAM-A</measure>
    <time_frame>1day before, 7，14 days after the intervene</time_frame>
    <description>scores of HAM-A were recorded on 1day before, 7，14 days after the intervene</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores of AIS</measure>
    <time_frame>1day before, 7，14 days after the intervene</time_frame>
    <description>scores of AIS were recorded on 1day before, 7，14 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores of HRSD</measure>
    <time_frame>1day before, 7，14 days after the intervene</time_frame>
    <description>scores of HRSD were recorded on 1day before, 7，14 days</description>
  </secondary_outcome>
  <other_outcome>
    <measure>inflammation mediators level in blood</measure>
    <time_frame>1day before, 7days after the intervene</time_frame>
    <description>the blood level of IL-6 and Hs-CRP were detected</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Percutaneous Coronary Intervention</condition>
  <arm_group>
    <arm_group_label>Acupuncture treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>blank control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>Acupuncturists apply the seven-days' electro-acupuncture treatment on the acupoints of Neiguan points and Daling points for 30min per day.</description>
    <arm_group_label>Acupuncture treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychotherapy</intervention_name>
    <description>Subjects in psychotherapy group would be accepted 20mins- psychotherapy per day.</description>
    <arm_group_label>Psychotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blank control</intervention_name>
    <description>Blank control subjects would be observed only during this investigation.</description>
    <arm_group_label>blank control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The main inclusion criteria were patients who underwent coronary angiography. Patients&#xD;
             suffer from Generalized anxiety disorder(GOD).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria were as follows: patients with chronic renal failure, chronic&#xD;
             liver disease, bone disorders, and/or thyroid disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huan Wang, M.D.</last_name>
      <phone>+8610-66876049</phone>
      <email>wanghuan_yy@163.com</email>
    </contact>
    <investigator>
      <last_name>Huan Wang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Huan Wang, MD</investigator_full_name>
    <investigator_title>director</investigator_title>
  </responsible_party>
  <keyword>acupuncture, PCI</keyword>
  <!-- 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/NCT03789344
org study id: 301FW
nct id: NCT03789344
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in
      Patients Treated with PCI
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from Baseline Heart Rate Variability at 7 days
time frame: at 1day before and 7 days after percutaneous coronary intervention
description: The primary efficacy variable was the heart rate variability of patients accepted the PCI treatment between control group
measure: Scores of HAM-A
time frame: 1day before, 7，14 days after the intervene
description: scores of HAM-A were recorded on 1day before, 7，14 days after the intervene
measure: Scores of AIS
time frame: 1day before, 7，14 days after the intervene
description: scores of AIS were recorded on 1day before, 7，14 days
measure: Scores of HRSD
time frame: 1day before, 7，14 days after the intervene
description: scores of HRSD were recorded on 1day before, 7，14 days
measure: inflammation mediators level in blood
time frame: 1day before, 7days after the intervene
description: the blood level of IL-6 and Hs-CRP were detected
arm group label: Acupuncture treatment
arm group type: Experimental
arm group label: Psychotherapy
arm group type: Active Comparator
arm group label: blank control
arm group type: Placebo Comparator
intervention type: Other
intervention name: acupuncture
description: Acupuncturists apply the seven-days' electro-acupuncture treatment on the acupoints of Neiguan points and Daling points for 30min per day.
arm group label: Acupuncture treatment
intervention type: Other
intervention name: Psychotherapy
description: Subjects in psychotherapy group would be accepted 20mins- psychotherapy per day.
arm group label: Psychotherapy
intervention type: Other
intervention name: blank control
description: Blank control subjects would be observed only during this investigation.
arm group label: blank control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Huan Wang, MD
investigator title: director