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

NCT ID: NCT03256175

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2016-06-30

Brief Summary

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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

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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

Conditions

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Myocardial Ischemia Cardiovascular Morbidity

Keywords

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Myocardial Protection Oxygen Exercise Test

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Both medical air and oxygen were supplied in compressed liquid form and available throughout the hospital. During the study, the medical gas cylinders shielded using an opaque temporary cover. Similarly the oxygen saturation was not displayed, but instead monitored by an independent third party.

Study Groups

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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

Group Type EXPERIMENTAL

Percutaneous Coronary Intervention

Intervention Type 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

Air

Patient was given Facemask without oxygen through out the procedure. 6 weeks post procedure, EST was arranged

Group Type PLACEBO_COMPARATOR

Percutaneous Coronary Intervention

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Soo Chin Chan, MBBS

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Anwar Suhami, MBBS

Role: STUDY_CHAIR

[email protected]

Other Identifiers

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1198.49

Identifier Type: -

Identifier Source: org_study_id