Condition category
Circulatory System
Date applied
14/08/2014
Date assigned
14/08/2014
Last edited
21/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Petra Bijsterveld

ORCID ID

Contact details

Academic Unit of Cardiovascular Medicine
Great George Street
Leeds
LS1 3EX
United Kingdom
-
p.bijsterveld@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17103

Study information

Scientific title

Myocardial perfusion and microvascular dysfunction in stable coronary artery disease during hyperoxaemia

Acronym

Study hypothesis

Coronary artery disease (CAD) is a leading cause of death and disability worldwide. Around 20-40% of the UK population will experience chest pain during their lifetime, accounting for 40% of acute hospital admissions. Oxygen has long been advocated as a therapeutic agent and treatment option in the management of chest pain, although the scientific basis for this is questionable and there is currently no clinical evidence to support the routine use of oxygen in the setting of myocardial ischaemia. Experimental data suggests hyperoxaemia may actually be harmful purported to be due to alteration in microvascular function. This study is divided into two parts: A. we intend to quantify myocardial blood flow with cardiovascular magnetic resonance (CMR) scanning. B. we intend to use novel invasive coronary physiological measurements to assess the dynamic response of the coronary microvasculature to the hyperoxaemic stimulation. This study will establish the implications of high flow oxygen on coronary microvascular function and may have a direct impact on clinical care and the management of patients presenting with chest pain.

Ethics approval

14/YH/1089

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

Administration of high flow oxygen

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Quantificaton of myocardial blood flow; timepoint(s): unspecified

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2014

Overall trial end date

01/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
Known coronary artery disease involving one or more major epicardial vessels (=2.5mm diameter) with severe coronary artery disease (coronary luminal stenosis severity =70% or FFR =0.8).

For the healthy volunteer group:
No known risk factors for underlying coronary artery disease

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 90; UK Sample Size: 90

Participant exclusion criteria

1. Clinically unstable
2. Previous coronary artery bypass grafting
3. Contraindication to adenosine (regular adenosine antagonist medication, significant reversible airways disease, second or third degree atrioventricular heart block, sinoatrial disease)
4. Pregnancy or breast feeding
5. Recent acute coronary syndrome (<6 weeks)
6. Nonsinus rhythm
7. Chronic obstructive airways disease with a history of hypercapnic respiratory failure
8. Three vessel coronary artery disease
9. Claustrophobia
10. Known adverse reaction to adenosine or iodinated contrast agents

Recruitment start date

01/09/2014

Recruitment end date

01/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Cardiovascular Medicine
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Heart Research UK; Grant Codes: TRP31/14

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://heart.bmj.com/content/102/Suppl_6/A146.3

Publication citations

Additional files

Editorial Notes

21/09/2016: Publication reference added.