Using a blood sampling device to analyze disease biomarkers in coronary artery disease patients

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

This study is testing a new blood sampling device to see if it can help find important disease markers in patients with coronary artery disease for better personalized treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: PlaqueTec Ltd (Industry-sponsored)
• Locations: 4 sites (Bournemouth and 3 other locations)
• Trial ID: NCT06259019 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the performance of a liquid biopsy system (LBS) for intracoronary blood sampling in patients with coronary artery disease. The study will collect and analyze blood samples from the coronary artery to identify key disease biomarkers. By generating comprehensive biomarker data, the research seeks to address existing knowledge gaps and support the development of personalized treatments for coronary artery disease. The study is coordinated by the Papworth Trials Unit Collaboration and funded by PlaqueTec.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with clinical evidence of obstructive coronary artery disease scheduled for elective coronary angiography or PCI.

Not a fit: Patients who have had a myocardial infarction within the last 30 days or those with severe chronic conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more tailored and effective treatments for patients with coronary artery disease.

How similar studies have performed: Other studies utilizing liquid biopsy approaches have shown promise in biomarker identification, suggesting potential success for this novel application in 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 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 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. Unsuitable coronary anatomy (vessel tortuosity \[\>45 degree bend\], moderate/ severe calcification angiographically, ostial disease).
3. Presence of thrombus in the target vessel.
4. Prior PCI or stent or graft in vessel identified for LBS sampling.
5. No clinical indication for either a PCI or a pressure wire assessment on any lesion.

Where this trial is running

Bournemouth and 3 other locations

• Royal Bournemouth Hospital — Bournemouth, United Kingdom (Recruiting)
• Bristol Heart Institute — Bristol, United Kingdom (Recruiting)
• Royal Papworth Hospital — Cambridge, United Kingdom (Recruiting)
• Norfolk and Norwich Hospital — Norwich, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Steve Hoole — Royal Papworth Hospital NHS Foundation Trust
• Study coordinator: Clinical Project Manager

Conditions Coronary Artery Disease; Liquid Biopsy System; Intracoronary; Biomarkers; PlaqueTec; BIOPATTERN