Study to Detect Biomarker Gradients in Coronary Arteries Using the Liquid Biopsy System (CS1)

The Liquid Biopsy System (LBS) is a new catheter (thin tube) designed for sampling blood directly from coronary arteries. These arteries supply blood to muscles of the heart and can become blocked by 'plaques' leading to chest pain (angina) and heart attacks. Recent research has shown that development of ' plaques' inside coronary arteries is controlled by chemicals (biomarkers) released into the blood from damaged areas of the artery wall. The LBS is designed to collect blood samples at the exact site of plaque formation. By testing these blood samples for biomarkers of plaque formation, it is hoped that new diagnostic tests and treatments for heart disease may be developed. The proposed investigation is use the LBS in humans to detect these biomarkers. The safety of the LBS has already been demonstrated in both human and animal studies. The study will enroll 70 patients with coronary artery disease who are undergoing routine percutaneous coronary intervention (PCI). PCI is a procedure used to open up a blocked coronary artery. It uses a catheter on the end of which is a special balloon that is inflated inside the blocked artery to open up the vessel and restore blood flow. A small metal spring (stent) is usually inserted to keep the blood vessel open. This study will test if the LBS device, when used just prior to a PCI procedure, can detect biomarkers released by diseased coronary arteries. The study will also determine if the presence of these biomarkers is linked to the long term health of the patient. The study will take place at Papworth Hospital, over a period of approximately 8 months (including telephone based patient followup calls 30 days, 6 months, 1, 2 and 3 years after the procedure to determine patient health).