Liquid Biopsy System Intracoronary Blood Sampling and Analysis to Characterise Disease Biomarkers in Patients With Coronary Disease

Coronary Artery Disease Clinical Trial

— BIOPATTERN  

Official title:

Site of Disease BIOmolecule Capture and Analysis in PATienTs With Established Coronary Disease undERgoing iNtracoronary Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259019
• Other study ID #: 65112021
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: PlaqueTec Ltd
• Contact: Clinical Project Manager
• Phone: 01223638000
• Email: papworth.biopattern[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 not for PCI 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 other 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. Target lesion requires PCI

3. In same vessel as lesion requiring PCI

4. Unsuitable coronary anatomy (vessel tortuosity [>45 degree bend], moderate/ severe calcification angiographically, ostial disease).

5. Presence of thrombus in the target vessel.

6. Prior PCI or stent in vessel identified for LBS sampling

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Liquid 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.

Locations

Country	Name	City	State
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Bristol Heart Institute	Bristol
United Kingdom	Royal Papworth Hospital	Cambridge
United Kingdom	Norfolk and Norwich Hospital	Norwich

Sponsors (2)

Lead Sponsor	Collaborator
PlaqueTec Ltd	Royal Papworth Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events in subjects in whom the LBS is used		During intervention and subsequent 30 days
Primary	Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1		Single time point (time of intervention)
Primary	Liquid Biopsy System (LBS) performance: successful positioning and successful intracoronary sampling	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	Single time point (time of intervention)
Secondary	Correlations between primary outcome measure proteins and: patient subsets and lesion level data	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	Single time point (time of intervention)