Clinical trial NCT03256175: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Cardiovascular Morbidity
Keywords: Myocardial Protection
Oxygen
Exercise Test
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: The primary objective of this study was to assess the myocardial protection
timeFrame: 6 hours and 24 hours after the procedure
Secondary outcomes:
measure: To assess the utility of peri-PCI oxygenation to improve cardiovascular fitness
timeFrame: 6 weeks post procedure
measure: To assess the utility of peri-PCI oxygenation to improve autonomic response
timeFrame: 6 weeks post procedure
measure: To assess the utility of peri-PCI oxygenation to improve autonomic response
timeFrame: 6 weeks post procedure
Other outcomes:
Locations:
Study officials:
affiliation: schin1022@yahoo.com
name: Soo Chin Chan, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: anwar@ummc.edu.my
name: Anwar Suhami, MBBS
role: STUDY_CHAIR
References: