Clinical trial NCT06259019: Liquid Biopsy System Intracoronary Blood Sampling and Analysis to Characterise Disease Biomarkers in Patients With Coronary Disease
Official title: Site of Disease BIOmolecule Capture and Analysis in PATienTs With Established Coronary Disease undERgoing iNtracoronary Assessment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Liquid Biopsy System
Intracoronary
Biomarkers
PlaqueTec
BIOPATTERN
Lead sponsor: PlaqueTec Ltd
Sponsor class: INDUSTRY
Collaborators: name: Royal Papworth Hospital
First posted: 2024-02-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1
timeFrame: Single time point (time of intervention)
measure: Liquid Biopsy System (LBS) performance: successful positioning and successful intracoronary sampling
timeFrame: Single time point (time of intervention)
Secondary outcomes:
measure: Correlations between primary outcome measure proteins and: patient subsets and lesion level data
timeFrame: Single time point (time of intervention)
Other outcomes:
measure: Incidence of adverse events in subjects in whom the LBS is used
timeFrame: During intervention and subsequent 30 days
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Hospital
Study officials:
affiliation: Royal Papworth Hospital NHS Foundation Trust
name: Steve Hoole
role: PRINCIPAL_INVESTIGATOR
References: