<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/NCT03256175</url>
  </required_header>
  <id_info>
    <org_study_id>1198.49</org_study_id>
    <nct_id>NCT03256175</nct_id>
  </id_info>
  <brief_title>The Effect of Peri-percutaneous Coronary Intervention Oxygenation on Myocardial Protection &amp; Cardiovascular Fitness</brief_title>
  <official_title>The Effects Of Peri-Percutaneous Coronary Intervention Oxygenation On Myocardial Protection And Cardiovascular Function: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Elective percutaneous coronary intervention (PCI) is often associated with myocardial&#xD;
      necrosis evidenced by peri-procedural troponin release. This is a surrogate for subsequent&#xD;
      cardiovascular events. There is no study on the effect of peri-PCI oxygenation in in&#xD;
      myocardial protection and cardiopulmonary fitness outcome. Patients with higher baseline&#xD;
      cardiopulmonary fitness will have lower mortality.&#xD;
&#xD;
      This study is to assess the utility of oxygen to reduce ischaemia in patients with&#xD;
      significant stable coronary artery disease scheduled for elective PCI. The secondary&#xD;
      objective is to evaluate further effect of peri- PCI oxygenation on cardiovascular fitness&#xD;
      and autonomic response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVE: This study is to assess the utility of oxygen to reduce ischaemia in patients with&#xD;
      significant stable coronary artery disease scheduled for elective PCI. The secondary&#xD;
      objective is to evaluate further effect of peri- PCI oxygenation on cardiovascular fitness&#xD;
      and autonomic response.&#xD;
&#xD;
      STUDY DESIGN: Randomized double blinded prospective pilot study SAMPLE SIZE: 30 patients&#xD;
      scheduled for elective for PCI randomized to 2 groups, oxygen group ( 15L/min) and air group&#xD;
      METHOD: Patient whom fulfil inclusion criteria were recruited and randomized to 2 groups via&#xD;
      computer allocation system. The assigned inhaled gas will be delivered via high-flow mask at&#xD;
      15L/min for a minimum of 30 minutes immediately prior to and continued throughout the PCI&#xD;
      procedure. Patients were blinded throughout the procedure but the practising cardiologist and&#xD;
      staff nurses were not blinded. Routine care continued post PCI. Blood sampling for Troponin I&#xD;
      was taken at 6 hours and 24 hours following stent implantation. Patients were discharged one&#xD;
      day after the procedure as per current routine practice.&#xD;
&#xD;
      Patients were given routine follow up with the cardiac rehabilitation clinic in 4 weeks time&#xD;
      post discharge. EST was arranged 6 weeks post procedure PRIMARY OUTCOME MEASURE: Troponin I&#xD;
      at 6 and 24 hours SECONDARY OUTCOME MEASURE: METs, Heart Rate Recovery, Chronotropic Index&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">June 30, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Both medical air and oxygen were supplied in compressed liquid form and available throughout the hospital. During the study, the medical gas cylinders shielded using an opaque temporary cover. Similarly the oxygen saturation was not displayed, but instead monitored by an independent third party.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The primary objective of this study was to assess the myocardial protection</measure>
    <time_frame>6 hours and 24 hours after the procedure</time_frame>
    <description>this is done by comparing changes Troponin I at 6 (baseline) to 24 hours between both study arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the utility of peri-PCI oxygenation to improve cardiovascular fitness</measure>
    <time_frame>6 weeks post procedure</time_frame>
    <description>assessed by Functional capacity in METs-Maximum METs achieved</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the utility of peri-PCI oxygenation to improve autonomic response</measure>
    <time_frame>6 weeks post procedure</time_frame>
    <description>assessed by Heart Rate Recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the utility of peri-PCI oxygenation to improve autonomic response</measure>
    <time_frame>6 weeks post procedure</time_frame>
    <description>assessed by Chronotropic Index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Myocardial Ischemia</condition>
  <condition>Cardiovascular Morbidity</condition>
  <arm_group>
    <arm_group_label>Oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient was give 15L/min of Oxygen via HFM 30 mins before and continue through out the procedure. 6 weeks post procedure, EST was arranged</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Air</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patient was given Facemask without oxygen through out the procedure. 6 weeks post procedure, EST was arranged</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Coronary Intervention</intervention_name>
    <description>PCI technique (e.g. pre-dilatation vs. direct stenting and stent choice) was left to operator discretion. Stent post dilatation was permitted as per individual operator practice</description>
    <arm_group_label>Air</arm_group_label>
    <arm_group_label>Oxygen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged &gt;18 years&#xD;
&#xD;
          -  Haemodynamically important coronary artery disease (&gt;70% luminal stenosis&#xD;
             angiographically in ≥1 major epicardial coronary artery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant chronic airways disease with type-2 respiratory failure precluding safe&#xD;
             use of oxygen&#xD;
&#xD;
          -  Coronary stenoses where evidence of plaque instability is evident e.g. rest pain,&#xD;
             visual evidence of thrombus, elevation of Troponin T at baseline&#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_official>
    <last_name>Soo Chin Chan, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>schin1022@yahoo.com</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anwar Suhami, MBBS</last_name>
    <role>Study Chair</role>
    <affiliation>anwar@ummc.edu.my</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myocardial Protection</keyword>
  <keyword>Oxygen</keyword>
  <keyword>Exercise Test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03256175
org study id: 1198.49
nct id: NCT03256175
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Elective percutaneous coronary intervention (PCI) is often associated with myocardial
      necrosis evidenced by peri-procedural troponin release. This is a surrogate for subsequent
      cardiovascular events. There is no study on the effect of peri-PCI oxygenation in in
      myocardial protection and cardiopulmonary fitness outcome. Patients with higher baseline
      cardiopulmonary fitness will have lower mortality.

      This study is to assess the utility of oxygen to reduce ischaemia in patients with
      significant stable coronary artery disease scheduled for elective PCI. The secondary
      objective is to evaluate further effect of peri- PCI oxygenation on cardiovascular fitness
      and autonomic response.
OBJECTIVE: This study is to assess the utility of oxygen to reduce ischaemia in patients with
      significant stable coronary artery disease scheduled for elective PCI. The secondary
      objective is to evaluate further effect of peri- PCI oxygenation on cardiovascular fitness
      and autonomic response.

      STUDY DESIGN: Randomized double blinded prospective pilot study SAMPLE SIZE: 30 patients
      scheduled for elective for PCI randomized to 2 groups, oxygen group ( 15L/min) and air group
      METHOD: Patient whom fulfil inclusion criteria were recruited and randomized to 2 groups via
      computer allocation system. The assigned inhaled gas will be delivered via high-flow mask at
      15L/min for a minimum of 30 minutes immediately prior to and continued throughout the PCI
      procedure. Patients were blinded throughout the procedure but the practising cardiologist and
      staff nurses were not blinded. Routine care continued post PCI. Blood sampling for Troponin I
      was taken at 6 hours and 24 hours following stent implantation. Patients were discharged one
      day after the procedure as per current routine practice.

      Patients were given routine follow up with the cardiac rehabilitation clinic in 4 weeks time
      post discharge. EST was arranged 6 weeks post procedure PRIMARY OUTCOME MEASURE: Troponin I
      at 6 and 24 hours SECONDARY OUTCOME MEASURE: METs, Heart Rate Recovery, Chronotropic Index
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
masking description: Both medical air and oxygen were supplied in compressed liquid form and available throughout the hospital. During the study, the medical gas cylinders shielded using an opaque temporary cover. Similarly the oxygen saturation was not displayed, but instead monitored by an independent third party.
measure: The primary objective of this study was to assess the myocardial protection
time frame: 6 hours and 24 hours after the procedure
description: this is done by comparing changes Troponin I at 6 (baseline) to 24 hours between both study arms.
measure: To assess the utility of peri-PCI oxygenation to improve cardiovascular fitness
time frame: 6 weeks post procedure
description: assessed by Functional capacity in METs-Maximum METs achieved
measure: To assess the utility of peri-PCI oxygenation to improve autonomic response
time frame: 6 weeks post procedure
description: assessed by Heart Rate Recovery
measure: To assess the utility of peri-PCI oxygenation to improve autonomic response
time frame: 6 weeks post procedure
description: assessed by Chronotropic Index
arm group label: Oxygen
arm group type: Experimental
description: Patient was give 15L/min of Oxygen via HFM 30 mins before and continue through out the procedure. 6 weeks post procedure, EST was arranged
arm group label: Air
arm group type: Placebo Comparator
description: Patient was given Facemask without oxygen through out the procedure. 6 weeks post procedure, EST was arranged
intervention type: Procedure
intervention name: Percutaneous Coronary Intervention
description: PCI technique (e.g. pre-dilatation vs. direct stenting and stent choice) was left to operator discretion. Stent post dilatation was permitted as per individual operator practice
arm group label: Air
arm group label: Oxygen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Soo Chin Chan, MBBS
role: Principal Investigator
affiliation: schin1022@yahoo.com
last name: Anwar Suhami, MBBS
role: Study Chair
affiliation: anwar@ummc.edu.my
responsible party type: Sponsor
mesh term: Myocardial Ischemia
mesh term: Ischemia
sharing ipd: Undecided