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

The Effects Of Peri-Percutaneous Coronary Intervention Oxygenation On Myocardial Protection And Cardiovascular Function: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Cardiovascular Morbidity
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oxygen; 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	Procedure: Percutaneous Coronary Intervention; 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
PLACEBO_COMPARATOR: Air; Patient was given Facemask without oxygen through out the procedure. 6 weeks post procedure, EST was arranged	Procedure: Percutaneous Coronary Intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 hours and 24 hours after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the utility of peri-PCI oxygenation to improve cardiovascular fitness	assessed by Functional capacity in METs-Maximum METs achieved	6 weeks post procedure
To assess the utility of peri-PCI oxygenation to improve autonomic response	assessed by Heart Rate Recovery	6 weeks post procedure
To assess the utility of peri-PCI oxygenation to improve autonomic response	assessed by Chronotropic Index	6 weeks post procedure

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Soo Chin Chan, MBBS, schin1022@yahoo.com; Study Chair: Anwar Suhami, MBBS, anwar@ummc.edu.my

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): December 31, 2015
• Study Completion (ACTUAL): June 30, 2016

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (ACTUAL): August 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Oxygen; Myocardial Protection; Exercise Test
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 1198.49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No