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

February 6, 2024 updated by: PlaqueTec Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Liquid Biopsy System
Main trial arm, all recruited and enrolled patients will undergo intracoronary blood sampling using the Liquid Biospy System Device.
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.
Other Names:
  • LBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1
Time Frame: Single time point (time of intervention)
Single time point (time of intervention)
Liquid Biopsy System (LBS) performance: successful positioning and successful intracoronary sampling
Time Frame: 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
Single time point (time of intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between primary outcome measure proteins and: patient subsets and lesion level data
Time Frame: 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
Single time point (time of intervention)

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events in subjects in whom the LBS is used
Time Frame: During intervention and subsequent 30 days
During intervention and subsequent 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PlaqueTec Ltd

Collaborators

Royal Papworth Hospital

Investigators

  • Principal Investigator: Steve Hoole, Royal Papworth Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65112021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Liquid Biopsy System (LBS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe