Coronary Artery Disease
Conditions
Keywords
Liquid Biopsy System, Intracoronary, Biomarkers, PlaqueTec, BIOPATTERN
Brief summary
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 coronary artery blood sampling device (Liquid Biospy System, LBS) and establish its usefulness to collect a range of disease biomolecules from the coronary artery of interest. Using the data generated from extensive analysis of the blood samples, key biomarker data will be generated that will close a knowledge gap and facilitate the development of tailored treatments for coronary artery disease.
Interventions
DEVICELiquid Biopsy System (LBS)
Coronary artery catheter designed to mix intra-arterial flow and simultaneously extract multiple blood samples from around the site of coronary disease within a vessel of interest.
Sponsors
PlaqueTec Ltd
Royal Papworth Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stage 1 screening inclusion: 1. ≥18 years of age, have capacity and be willing to provide informed consent to participate 2. Clinical evidence of obstructive coronary artery disease and be scheduled for either: 1. Elective coronary angiography +/- proceed for stable angina OR 2. Elective PCI for stable angina with known bystander disease OR 3. Angiography +/- proceed for Troponin negative unstable angina Stage 2 screening inclusion: Suitable lesion identified meeting angiographic criteria for LBS deployment and Cardiologist comfortable to deploy OCT and LBS on study lesion before carrying out PCI on any lesion
Exclusion criteria
Stage 1 screening exclusion: 1. Myocardial Infarction within 30 days of procedure. 2. Chronic renal failure (eGFR\<30ml/min/1.73m2). 3. Contrast allergy. 4. Hypotension, shock or haemodynamic instability. 5. Ventricular arrhythmia. 6. Chronic Heart Failure (NYHA ≥ 3) or LVEF ≤ 30%. 7. Immunocompromised or receiving immunosuppressant therapy. 8. Any active disease that in the opinion of the investigator makes the subject unsuitable for the research procedure or subject life expectancy less than 1 year. 9. Active infection or sepsis (significant CRP elevation and/or requiring antibiotics). 10. Active systemic inflammatory condition. 11. Inability to receive anticoagulants or antiplatelets or uncorrected bleeding disorder or deranged platelet count. 12. Is pregnant. 13. Deemed high clinical risk or unsuitable for the procedure for any reason by the treating clinician. Stage 2 screening exclusion: 1. Target lesion is in the left main coronary artery. 2. Unsuitable coronary anatomy (vessel tortuosity \[\>45 degree bend\], moderate/ severe calcification angiographically, ostial disease). 3. Presence of thrombus in the target vessel. 4. Prior PCI or stent or graft in vessel identified for LBS sampling. 5. No clinical indication for either a PCI or a pressure wire assessment on any lesion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1 | Single time point (time of intervention) | — |
| Liquid Biopsy System (LBS) performance: successful positioning and successful intracoronary sampling | Single time point (time of intervention) | Success define as confirmed adequate positioning of the device across the identified lesion of interest and collection of sufficient whole blood from each functional port to generate \>100µl plasma once processed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlations between primary outcome measure proteins and: patient subsets and lesion level data | Single time point (time of intervention) | Patient level subsets: * With and without type 2 diabetes mellitus * Prior/no prior history of Myocardial Infarction (MI) Lesion level data: \- Coronary fibroatheroma cap thickness and lipid arc as measured by OCT image analysis |
Countries
United Kingdom
Contacts
CONTACTClinical Project Manager
CONTACTPlaqueTec General Manager
PRINCIPAL_INVESTIGATORSteve Hoole
Royal Papworth Hospital NHS Foundation Trust
Outcome results
None listed