<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/NCT02214082</url>
  </required_header>
  <id_info>
    <org_study_id>TIH-Cardio-001</org_study_id>
    <nct_id>NCT02214082</nct_id>
  </id_info>
  <brief_title>Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention</brief_title>
  <official_title>Feasibility and Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention (PCI) in a Tertiary Care Hospital in Karachi, Pakistan.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indus Hospital and Health Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indus Hospital and Health Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study intends to determine if there is any difference in the occurrence of major adverse&#xD;
      cardiology events in patients discharged on the same day as their elective cardiac&#xD;
      angioplasty or discharged one day after their angioplasty.&#xD;
&#xD;
      Hypothesize that same day discharge is as safe as a day later discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 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>Mortality</measure>
    <time_frame>Within 30 days post angioplasty</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients who require a 2nd angioplasty</measure>
    <time_frame>within 30 days of 1st angioplasty</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with bleed from the angioplasty site</measure>
    <time_frame>within 30 days post angioplasty</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of hospital re-admissions</measure>
    <time_frame>within 30 days of initial angioplasty</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">210</enrollment>
  <condition>Angioplasty</condition>
  <condition>Coronary</condition>
  <arm_group>
    <arm_group_label>Next day discharge</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>this group will be discharged as is the standard practice at our facility; i.e. the day after the PCI procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Same Day Discharge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will be discharged on the same day as their angioplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Same Day Discharge</intervention_name>
    <description>This group will be discharged home, on the same day after their elective angioplasty</description>
    <arm_group_label>Same Day Discharge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: :&#xD;
&#xD;
          -  Low risk lesion (according to the ACC classification)&#xD;
&#xD;
          -  Normal Pre Catheterization laboratory investigation&#xD;
&#xD;
          -  Procedure performed before 3 pm&#xD;
&#xD;
          -  procedure performed with ≤ 6 French guiding Catheter&#xD;
&#xD;
          -  EF ≥ 35%&#xD;
&#xD;
          -  living at a distance of within 15 kilometers from hospital&#xD;
&#xD;
          -  caregiver present at home&#xD;
&#xD;
          -  elective procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute PCI&#xD;
&#xD;
          -  high risk lesions (according to the ACC classification)&#xD;
&#xD;
          -  deranged Pre Catheterization laboratory investigations&#xD;
&#xD;
          -  Age &gt;70&#xD;
&#xD;
          -  Severe LV dysfunction, CVA&#xD;
&#xD;
          -  procedure to be performed with a guiding catheter &gt;6F&#xD;
&#xD;
          -  Use of IIb/IIIa inhibitor&#xD;
&#xD;
          -  Creatinine clearance of &lt; 50&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sajid Dhakam</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indus Hospital and Health Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Indus Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sind</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>July 19, 2017</last_update_submitted>
  <last_update_submitted_qc>July 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indus Hospital and Health Network</investigator_affiliation>
    <investigator_full_name>Sajid H. Dhakam</investigator_full_name>
    <investigator_title>Faculty, Cardiology</investigator_title>
  </responsible_party>
  <!-- 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/NCT02214082
org study id: TIH-Cardio-001
nct id: NCT02214082
lead sponsor: 
has dmc: No
Study intends to determine if there is any difference in the occurrence of major adverse
      cardiology events in patients discharged on the same day as their elective cardiac
      angioplasty or discharged one day after their angioplasty.

      Hypothesize that same day discharge is as safe as a day later discharge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mortality
time frame: Within 30 days post angioplasty
measure: Number of patients who require a 2nd angioplasty
time frame: within 30 days of 1st angioplasty
measure: Number of patients with bleed from the angioplasty site
time frame: within 30 days post angioplasty
measure: number of hospital re-admissions
time frame: within 30 days of initial angioplasty
arm group label: Next day discharge
arm group type: No Intervention
description: this group will be discharged as is the standard practice at our facility; i.e. the day after the PCI procedure
arm group label: Same Day Discharge
arm group type: Experimental
description: Patients in this arm will be discharged on the same day as their angioplasty.
intervention type: Other
intervention name: Same Day Discharge
description: This group will be discharged home, on the same day after their elective angioplasty
arm group label: Same Day Discharge
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Sajid Dhakam
role: Principal Investigator
affiliation: Indus Hospital and Health Network
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Indus Hospital and Health Network
investigator full name: Sajid H. Dhakam
investigator title: Faculty, Cardiology