Measuring Blood Flow in Heart Vessels With a New Fibre Optic Sensor
Research type
Research Study
Full title
A single centre, prospective, feasibility study of the iKOs™ coronary pressure and flow rapid-exchange microcatheter and iKOr™ console in patients with coronary heart disease undergoing coronary physiology investigations.
IRAS ID
305877
Contact name
Anthony Mathur
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
Coronary Heart Disease (CHD) is due to a build-up of plaque (fatty substances) in the heart vessels (coronary arteries). The build-up of plaque can slow or stop the flow of blood to the heart muscle. This causes angina (chest pain) or heart attacks. We can see the amount of vessel narrowing and plaque disease with an angiogram. An angiogram is an X-ray video of the heart vessels. Doctors decide if a stent is needed to keep the vessel open.
We get better information if we can assess the blood flow and the blood supply to the heart muscle as well. To do this requires two different measuring probes and more time. The new iKOr micro-catheter uses fibre-optics to provide both measurements in one go.
This is a first-in-human study to see how safe and accurate the micro-catheter is. A grant from Innovate UK (Precision Medicine Investment Accelerator Award) and Echopoint Medical Ltd are providing the funding. The study takes place at St Bartholomew’s Hospital.
We will invite ten patients who need coronary artery assessment to take part. Each participant is in the study for 2 months. The participant has an angiogram and standard blood flow measurements first. After this we use the micro-catheter to get blood flow and blood supply measurements. The research team will call the participants at home in the first week and after 6 weeks.
We think better results for patients are possible if we assess more than just how narrow the heart artery looks. The micro-catheter should be quick and easy to use. It will provide the information needed to help diagnose conditions that affects more women and diabetics. It will help provide more precise treatment for all patients with coronary heart disease.REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0447
Date of REC Opinion
15 Jun 2022
REC opinion
Favourable Opinion