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

Myocardial Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256175
• Other study ID #: 1198.49
• Status: Completed
• Phase: N/A
• First received: July 31, 2017
• Last updated: October 24, 2017
• Start date: July 1, 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: October 2017
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Morbidity
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	To assess the utility of peri-PCI oxygenation to improve autonomic response	assessed by Heart Rate Recovery	6 weeks post procedure
Secondary	To assess the utility of peri-PCI oxygenation to improve autonomic response	assessed by Chronotropic Index	6 weeks post procedure