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Recruiting NCT06259019

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

No phase Interventional Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liquid Biopsy System (LBS).
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1 [Time frame: 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)]
Secondary outcome measures (1)
  • Correlations between primary outcome measure proteins and: patient subsets and lesion level data [Time frame: Single time point (time of intervention)]

Eligibility criteria

Inclusion criteria

Stage 1 screening inclusion:

  • ≥18 years of age, have capacity and be willing to provide informed consent to participate
  • Clinical evidence of obstructive coronary artery disease and be scheduled for either:
  • Elective coronary angiography +/- proceed for stable angina OR
  • Elective PCI for stable angina with known bystander disease OR
  • 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:

  • Myocardial Infarction within 30 days of procedure.
  • Chronic renal failure (eGFR<30ml/min/1.73m2).
  • Contrast allergy.
  • Hypotension, shock or haemodynamic instability.
  • Ventricular arrhythmia.
  • Chronic Heart Failure (NYHA ≥ 3) or LVEF ≤ 30%.
  • Immunocompromised or receiving immunosuppressant therapy.
  • 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.
  • Active infection or sepsis (significant CRP elevation and/or requiring antibiotics).
  • Active systemic inflammatory condition.
  • Inability to receive anticoagulants or antiplatelets or uncorrected bleeding disorder or deranged platelet count.
  • Is pregnant.
  • Deemed high clinical risk or unsuitable for the procedure for any reason by the treating clinician.

Stage 2 screening exclusion:

  • Target lesion is in the left main coronary artery.
  • Unsuitable coronary anatomy (vessel tortuosity \[>45 degree bend\], moderate/ severe calcification angiographically, ostial disease).
  • Presence of thrombus in the target vessel.
  • Prior PCI or stent or graft in vessel identified for LBS sampling.
  • No clinical indication for either a PCI or a pressure wire assessment on any lesion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United Kingdom · 4 centers
  • Royal Bournemouth Hospital — Bournemouth
  • Bristol Heart Institute — Bristol
  • Royal Papworth Hospital — Cambridge
  • Norfolk and Norwich Hospital — Norwich

Identifiers

NCT: NCT06259019 · 65112021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗