Non-invasive assessment of cardiovascular risk
| ISRCTN | ISRCTN27990239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27990239 |
| Secondary identifying numbers | SEPOC1 |
- Submission date
- 02/09/2013
- Registration date
- 12/09/2013
- Last edited
- 12/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
School of Medicine
University of St Andrews
North Haugh
St Andrews
KY16 9TF
United Kingdom
| cj21@st-andrews.ac.uk |
Study information
| Study design | Single site medical device feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled 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 | Assessing the use of light as a non-invasive tool for the evaluation of individual risk of cardiovascular disease |
| Study objectives | 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(s) | Ref: 13/SS/0172. The study will be reviewed by South East Scotland REC 2 on 25th September 2013. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2014 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2014 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
KY16 9TF
United Kingdom
Sponsor information
University/education
Research BD and Contracts
The Gateway
North Haugh
St Andrews
KY16 9RJ
Scotland
United Kingdom
| Website | http://www.st-andrews.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/02wn5qz54 |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
