Myocardial perfusion and microvascular dysfunction in stable coronary artery disease during hyperoxaemia
| ISRCTN | ISRCTN67819491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67819491 |
| Protocol serial number | 17103 |
| Sponsor | University of Leeds (UK) |
| Funder | Heart Research UK; Grant Codes: TRP31/14 |
- Submission date
- 14/08/2014
- Registration date
- 14/08/2014
- Last edited
- 21/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Petra Bijsterveld
Scientific
Scientific
Academic Unit of Cardiovascular Medicine
Great George Street
Leeds
LS1 3EX
United Kingdom
| p.bijsterveld@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Interventional; Design type: Treatment |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Myocardial perfusion and microvascular dysfunction in stable coronary artery disease during hyperoxaemia |
| Study objectives | 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(s) | 14/YH/1089 |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Intervention | Administration of high flow oxygen |
| Intervention type | Other |
| Primary outcome measure(s) |
Quantificaton of myocardial blood flow; timepoint(s): unspecified |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2015 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 90 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2014 |
| Date of final enrolment | 01/09/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Unit of Cardiovascular Medicine
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/09/2016: Publication reference added.
