An interventional study of Percutaneous Coronary Intervention in Myocardial Ischemia and Cardiovascular Morbidity, sponsored by University of Malaya. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-25.
Sponsored by University of Malaya · Not applicable, Interventional, and Basic science
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
Exclusion Criteria:
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
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
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.
Time frame: 6 hours and 24 hours after the procedure
To assess the utility of peri-PCI oxygenation to improve cardiovascular fitness
assessed by Functional capacity in METs-Maximum METs achieved
Time frame: 6 weeks post procedure
To assess the utility of peri-PCI oxygenation to improve autonomic response
assessed by Heart Rate Recovery
Time frame: 6 weeks post procedure
To assess the utility of peri-PCI oxygenation to improve autonomic response
assessed by Chronotropic Index
Time frame: 6 weeks post procedure
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University of Malaya