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The Effect of Peri-percutaneous Coronary Intervention Oxygenation on Myocardial Protection & Cardiovascular Fitness

Primary Purpose

Myocardial Ischemia, Cardiovascular Morbidity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Myocardial Ischemia focused on measuring Myocardial Protection, Oxygen, Exercise Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients aged >18 years
  • Haemodynamically important coronary artery disease (>70% luminal stenosis angiographically in ≥1 major epicardial coronary artery

Exclusion Criteria:

  • Significant chronic airways disease with type-2 respiratory failure precluding safe use of oxygen
  • Coronary stenoses where evidence of plaque instability is evident e.g. rest pain, visual evidence of thrombus, elevation of Troponin T at baseline

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Oxygen

    Air

    Arm 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

    Patient was given Facemask without oxygen through out the procedure. 6 weeks post procedure, EST was arranged

    Outcomes

    Primary Outcome Measures

    The primary objective of this study was to assess the myocardial protection
    this is done by comparing changes Troponin I at 6 (baseline) to 24 hours between both study arms.

    Secondary Outcome Measures

    To assess the utility of peri-PCI oxygenation to improve cardiovascular fitness
    assessed by Functional capacity in METs-Maximum METs achieved
    To assess the utility of peri-PCI oxygenation to improve autonomic response
    assessed by Heart Rate Recovery
    To assess the utility of peri-PCI oxygenation to improve autonomic response
    assessed by Chronotropic Index

    Full Information

    First Posted
    July 31, 2017
    Last Updated
    October 24, 2017
    Sponsor
    University of Malaya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03256175
    Brief Title
    The Effect of Peri-percutaneous Coronary Intervention Oxygenation on Myocardial Protection & Cardiovascular Fitness
    Official Title
    The Effects Of Peri-Percutaneous Coronary Intervention Oxygenation On Myocardial Protection And Cardiovascular Function: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (Actual)
    Primary Completion Date
    December 31, 2015 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Malaya

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Ischemia, Cardiovascular Morbidity
    Keywords
    Myocardial Protection, Oxygen, Exercise Test

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes 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.
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oxygen
    Arm Type
    Experimental
    Arm 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 Title
    Air
    Arm Type
    Placebo Comparator
    Arm Description
    Patient was given Facemask without oxygen through out the procedure. 6 weeks post procedure, EST was arranged
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous Coronary Intervention
    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
    Primary Outcome Measure Information:
    Title
    The primary objective of this study was to assess the myocardial protection
    Description
    this is done by comparing changes Troponin I at 6 (baseline) to 24 hours between both study arms.
    Time Frame
    6 hours and 24 hours after the procedure
    Secondary Outcome Measure Information:
    Title
    To assess the utility of peri-PCI oxygenation to improve cardiovascular fitness
    Description
    assessed by Functional capacity in METs-Maximum METs achieved
    Time Frame
    6 weeks post procedure
    Title
    To assess the utility of peri-PCI oxygenation to improve autonomic response
    Description
    assessed by Heart Rate Recovery
    Time Frame
    6 weeks post procedure
    Title
    To assess the utility of peri-PCI oxygenation to improve autonomic response
    Description
    assessed by Chronotropic Index
    Time Frame
    6 weeks post procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients aged >18 years Haemodynamically important coronary artery disease (>70% luminal stenosis angiographically in ≥1 major epicardial coronary artery Exclusion Criteria: Significant chronic airways disease with type-2 respiratory failure precluding safe use of oxygen Coronary stenoses where evidence of plaque instability is evident e.g. rest pain, visual evidence of thrombus, elevation of Troponin T at baseline
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Soo Chin Chan, MBBS
    Organizational Affiliation
    schin1022@yahoo.com
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Anwar Suhami, MBBS
    Organizational Affiliation
    anwar@ummc.edu.my
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    The Effect of Peri-percutaneous Coronary Intervention Oxygenation on Myocardial Protection & Cardiovascular Fitness

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