ISRCTN - ISRCTN27990239: Non-invasive assessment of cardiovascular risk

Plain English Summary

Background and study aims
Cardiovascular disease (CVD) covers a number of heart and circulatory diseases including heart attack, stroke, coronary artery disease and heart failure. In the UK it is the cause of a quarter of all deaths and is thought to cost the economy around £19 billion a year. CVD has a long phase where the disease is present but the sufferer does not show symptoms. There is a need to develop a test where CVD and people at risk of developing the disease can be identified as early as possible so that they can receive the care they need. This study aims to test a new, simple, low-cost medical device which has been developed to assess a persons risk of CVD. The device shines a light on the patients arm to see if the blood vessels are responding the way they should to a period of decreased blood flow or if they are showing signs of disease. The study will test how reliable this new device is and if it is able to spot patients who have CVD or who may go on to develop CVD in the future. It will also look at whether the new test is acceptable to patients by asking them for feedback about their experience.

Who can participate?
The study involves male and female participants who are 18-80 years old and attending hospital for tests relating to CVD.

What does the study involve?
Participants complete one study visit where one measurement will be taken with the new device and questions asked about the participants medical history, demographics and their experience of the test. Participants who agree to follow up will then be followed for 10 years by the research team who will access their medical records and record results of any tests relating to CVD.

What are the possible benefits and risks of participating?
There is no direct benefit to participants taking part in the study; however, this research may lead to the development of a new test which could help others in the future. The risks involved in taking part in the study are very small and similar to that of getting your blood pressure taken.

Where is the study run from?
The study will be run at one site in Ninewells Hospital, Dundee, Scotland (UK).

When is the study starting and how long is it expected to run for?
Recruitment will begin around March 2014 and 200 study visits will be completed over a period of 4 months. There will then be a 10 year follow up period.

Who is funding the study?
The study is funded by Northwood Trust and Scottish Enterprise, UK.

Who is the main contact?
Professor C. Jackson
cj21@st-andrews.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Cathy Jackson

ORCID ID

Contact details

School of Medicine
University of St Andrews
North Haugh
St Andrews
KY16 9TF
United Kingdom
cj21@st-andrews.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SEPOC1

Study information

Scientific title

Assessing the use of light as a non-invasive tool for the evaluation of individual risk of cardiovascular disease

Acronym

Study hypothesis

Is a new test using light a reliable indicator of an individual's risk of developing cardiovascular disease?

Primary objective
To verify that the investigational device works as proposed by the manufacturer in a clinical setting.

Secondary Objectives
1. To determine the correlation between measurements made using photonics after induced ischaemia on a patients forearm and other currently used diagnostic evaluations of CVD.
2. To determine which of the above, independently, most strongly predicts exacerbation rates retrospectively (current diagnostic evaluations or photonics device).
3. To determine the acceptability of the photonic measurement as a potential screening tool for CVD.

Ethics approval

Ref: 13/SS/0172. The study will be reviewed by South East Scotland REC 2 on 25th September 2013.

Study design

Single site medical device feasibility study

Primary study design

Interventional

Secondary study design

Non randomised controlled 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

Intervention

Participants will undergo one test with the new device. This consists of having an inflatable blood pressure cuff placed on the upper arm and a low intensity light source shone on the lower arm. The test takes around 10mins to compete in total. Participants will then be asked questions regarding their experience of the new test.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

The reliability of the device as measured by number of decipherable measurements produced during the study.

Secondary outcome measures

1. Correlation between device measurement and current diagnostic results
2. Correlation between follow up exacerbation rate and device measurement
3. Acceptability of device measurements as described by participant feedback scores and number of adverse device effects recorded

Overall trial start date

01/03/2014

Overall trial end date

30/06/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Written informed consent given by participant.
2. Male or female patients aged 18 to 80 years inclusive.
3. Undergoing investigations for cardiovascular disease (CVD)
4. Is likely to have, or has had recent diagnostic investigations performed as part of routine clinical care relevant to diagnosis of CVD

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, or cardiologist might compromise the safety of the patient
2. Females who are known to be pregnant or lactating

Recruitment start date

01/03/2014

Recruitment end date

30/06/2024

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Medicine
St Andrews
KY16 9TF
United Kingdom

Sponsor information

Organisation

University of St Andrews (UK)

Sponsor details

Research BD and Contracts
The Gateway
North Haugh
St Andrews
KY16 9RJ
United Kingdom