Skip to main content
OpenTrials
Completed

NCT Number: NCT03256175

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Procedure

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 outcomes

  1. The primary objective of this study was to assess the myocardial protection

    Time frame: 6 hours and 24 hours after the procedure

    this is done by comparing changes Troponin I at 6 (baseline) to 24 hours between both study arms.

Secondary outcomes

  1. To assess the utility of peri-PCI oxygenation to improve cardiovascular fitness

    Time frame: 6 weeks post procedure

    assessed by Functional capacity in METs-Maximum METs achieved

  2. To assess the utility of peri-PCI oxygenation to improve autonomic response

    Time frame: 6 weeks post procedure

    assessed by Heart Rate Recovery

  3. To assess the utility of peri-PCI oxygenation to improve autonomic response

    Time frame: 6 weeks post procedure

    assessed by Chronotropic Index

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Aug 21, 2017
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.