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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: Liquid Biopsy System (LBS)

• Registration Number: NCT06259019
• Lead Sponsor: PlaqueTec Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-14
• Study First Submitted: 2023-12-12
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14
• Primary Completion: 2025-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liquid Biopsy System	Liquid Biopsy System (LBS)	Main trial arm, all recruited and enrolled patients will undergo intracoronary blood sampling using the Liquid Biospy System Device.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Bristol Heart Institute; 🇬🇧 Bristol, United Kingdom

Norfolk and Norwich Hospital; 🇬🇧 Norwich, United Kingdom

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Royal Papworth Hospital; 🇬🇧 Cambridge, United Kingdom