Condition category
Circulatory System
Date applied
20/07/2015
Date assigned
20/08/2015
Last edited
20/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Timothy Chico

ORCID ID

Contact details

Department of Cardiovascular Science
University of Sheffield
Medical School
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
+44 (0)114 222 2396
t.j.chico@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

STH18992

Study information

Scientific title

Quantitative assessment and characterization of microvascular function using diffuse optical tomography

Acronym

Study hypothesis

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

Not provided at time of registration.

Study design

Observational

Primary study design

Observational

Secondary study design

Pilot feasibility trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Primary outcome measures

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 trial start date

01/08/2015

Overall trial end date

31/07/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

01/09/2015

Recruitment end date

30/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
S10 2TN
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust

Sponsor details

D Floor
Royal Hallamashire Hospital
Glossop Road
Sheffield
S10 2TN
United Kingdom
+44 (0)114 271 2763
nana.theodorou@sth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

University of Sheffield

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes