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
About this trial
This is an interventional basic science trial for Myocardial Ischemia focused on measuring Myocardial Protection, Oxygen, Exercise Test
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
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
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
Learn more about this trial
The Effect of Peri-percutaneous Coronary Intervention Oxygenation on Myocardial Protection & Cardiovascular Fitness
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