Measuring blood vessel function using diffuse optical tomography
| ISRCTN | ISRCTN27674506 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27674506 |
| Protocol serial number | STH18992 |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Funder | University of Sheffield |
- Submission date
- 20/07/2015
- Registration date
- 20/08/2015
- Last edited
- 20/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Atherosclerosis is a serious disease where fatty substances, called plaques, build up in the arteries. The plaques can cause hardening and narrowing of the arteries, which leads to reduced flow of blood through the blood vessels. Factors which increase the risk of a person developing atherosclerosis, such as smoking, as well as conditions such as diabetes, are also thought to increase a persons’ risk of developing microvascular disease (MVD). MVD is a disease where the small arteries in the heart become narrowed because of plaque. Therefore when the body’s demand for oxygen is increased by stress or exercise, the vessels can’t expand to increase the blood supply to the coronary arteries, which can lead to a heart attack. The usual test plaque in the arteries of the heart is coronary angiography, which uses a dye and special x-rays to show how blood is moving through the coronary arteries. The aim of this study is to find out whether using a technique called diffuse optical tomography (DOT), which painlessly shines light into the arm and measures the reflections, would be able to more accurately assess microvascular function than existing tests.
Who can participate?
Adult suffering from diabetes, or who have had a heart attack, or who are awaiting coronary angiography
What does the study involve?
All participants undergo DOT, which involves having near-infrared light shone through their arm in order to test how well the blood is flowing in the main artery in the upper arm (brachial artery). This will show if the blood flow is restricted in any way due to plaque build-up. For the participants who are having a coronary angiogram, the results of this are compared to the results of the DOT test, to see if there is a link.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
August 2015 to July 2018
Who is funding the study?
University of Sheffield (UK)
Who is the main contact?
Dr Timothy Chico
t.j.chico@sheffield.ac.uk
Contact information
Scientific
Department of Cardiovascular Science
University of Sheffield
Medical School
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
| Phone | +44 (0)114 222 2396 |
|---|---|
| t.j.chico@sheffield.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational |
| Secondary study design | Pilot feasibility trial |
| Study type | Participant information sheet |
| Scientific title | Quantitative assessment and characterization of microvascular function using diffuse optical tomography |
| Study objectives | We hypothesise that diffuse optical tomography can detect differences in vascular function between healthy participants and people with diabetes or previous heart attack, or between people with and without coronary artery disease on angiography. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Cardiovascular disease and diabetes |
| Intervention | Measurement of vascular function in the forearm by diffuse optical tomography during reactive hyperaemia response after brachial artery occlusion |
| Intervention type | Device |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Vascular function parameters measured by diffuse optical tomography after 5min brachial artery occlusion |
| Key secondary outcome measure(s) |
Feasibility and reproducibility of vascular function measurement by diffuse optical tomography |
| Completion date | 31/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | Healthy volunteers 1. Aged between 18-80 years 2. Ability to read and speak English to a level allowing understanding of the patient information and to give consent to participate Diabetics: 1. Aged between 18-80 years 2. Ability to read and speak English to a level allowing understanding of the patient information and to give consent to participate 3. Diagnosed as type 1 or 2 diabetic for at least 12 months Prior myocardial infarction: 1. Aged between 18-80 years 2. Ability to read and speak English to a level allowing understanding of the patient information and to give consent to participate 3. Suffered a myocardial infarction at least 1 month previously Patients awaiting coronary angiography: 1. Aged between 18-80 years 2. Ability to read and speak English to a level allowing understanding of the patient information and to give consent to participate 3. Awaiting an invasive or CT coronary angiogram for clinical reasons |
| Key exclusion criteria | Healthy volunteers: 1. No history of diabetes, myocardial infarction, or major cardiovascular disease 2. No painful arms or health problems preventing blood pressure cuff inflation 3. No lymphoedema of the arm Diabetics: 1. No painful arms or health problems preventing blood pressure cuff inflation 2. No lymphoedema of the arm Prior myocardial infarction: 4. No painful arms or health problems preventing blood pressure cuff inflation 5. No lymphoedema of the arm Patients awaiting coronary angiography: 1. No painful arms or health problems preventing blood pressure cuff inflation 2. No lymphoedema of the arm 3. Not diabetic or known to have suffered a myocardial infarction in the past |
| Date of first enrolment | 01/09/2015 |
| Date of final enrolment | 30/08/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
S10 2TN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
