Measuring blood vessel function using diffuse optical tomography

ISRCTN	ISRCTN27674506
DOI	https://doi.org/10.1186/ISRCTN27674506
Secondary identifying numbers	STH18992

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Timothy Chico
Scientific

Department of Cardiovascular Science
University of Sheffield
Medical School
Beech Hill Road
Sheffield
S10 2RX
United Kingdom

Phone	+44 (0)114 222 2396
Email	t.j.chico@sheffield.ac.uk

Study information

Study design	Observational
Primary study design	Observational
Secondary study design	Pilot feasibility trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Vascular function parameters measured by diffuse optical tomography after 5min brachial artery occlusion
Secondary outcome measures	Feasibility and reproducibility of vascular function measurement by diffuse optical tomography
Overall study start date	01/08/2015
Completion date	31/07/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield
S10 2TN
United Kingdom

Sponsor information

Sheffield Teaching Hospitals NHS Foundation Trust
Hospital/treatment centre

D Floor, Royal Hallamashire Hospital
Glossop Road
Sheffield
S10 2TN
England
United Kingdom

Phone	+44 (0)114 271 2763
Email	nana.theodorou@sth.nhs.uk
"ROR"	https://ror.org/018hjpz25

Funders

Funder type

University/education

University of Sheffield

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	We will present our findings at national and international conferences, and submit manuscripts to peer-reviewed journals, with preference to those which deposit publications in open access databases to increase free dissemination. Lay summaries of the research will be provided to the media office for press release. Once the findings are published in a peer-reviewed journal, a lay summary will be sent to participants by post.
IPD sharing plan