BIOPATTERN v1.1
Research type
Research Study
Full title
Site of disease BIOmolecule capture and analysis in PATienTs with established coronary disease undERgoing iNtracoronary assessment (BIOPATTERN)
IRAS ID
318098
Contact name
Stephen Hoole
Contact email
Sponsor organisation
PlaqueTec
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Coronary Artery Disease (CAD) is caused by atherosclerosis, an inflammatory condition whereby fatty material (plaque) builds-up in heart arteries, causing them to narrow and starve the heart muscle of oxygen and nutrients. A potentially fatal heart attack results when plaques become unstable and rupture, usually requiring revascularisation (restoring blood flow by a surgical procedure). A standard ‘one-size-fits-all’ treatment approach to lower the risk of this is used in all patients, including lifestyle modification and medication to control blood pressure and cholesterol. Despite this, there remains over 100,000 UK hospital admissions each year due to heart attack.
This approach contrasts with the ‘personalised medicine’ approach used in modern cancer care whereby cancers are characterised to enable tailoring of treatments to a patient’s specific cancer subtype, maximising therapeutic response.
Aiming to address this, the Liquid Biopsy System (LBS) is uniquely capable of measuring local biomarker release at the site of an inflamed plaque. This enables the characterisation of disease that could inform patient care and aid targeting of patient-specific precision medicines.
BIOPATTERN will involve 300 patients with CAD who are already scheduled for a coronary procedure at specialist NHS cardiac centres across England. During their planned procedure, patients meeting inclusion/exclusion criteria who have consented to participate, will be enrolled and undergo intra-coronary imaging and LBS blood sampling. Study involvement will add about 30 minutes to their procedure and in addition to routine care, subjects will be reviewed by phone 30 days later.
The aim of this research, proposed and funded by PlaqueTec and co-ordinated by Papworth Trials Unit Collaboration, is to demonstrate the performance of the LBS and establish its ability to characterise and discriminate disease type. Alongside key endpoint analysis, extensive site-of-disease biomarker data will be generated that will close a knowledge gap and facilitate the development of tailored treatments.
REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0137
Date of REC Opinion
30 Oct 2022
REC opinion
Favourable Opinion