Coronary Artery Endothelial Dysfunction with drug coated balloons
Research type
Research Study
Full title
Comparison of intracoronary Endothelial dysfunction in patients with coronary artery disease treated with drug coated balloon angioplasty and drug eluting stents
IRAS ID
262024
Contact name
Simon Eccleshall
Contact email
Sponsor organisation
Norfolk and Norwich University Hospital
Duration of Study in the UK
3 years, 4 months, 8 days
Research summary
Heart attacks are caused by atherosclerosis of the coronary arteries. The coronary arteries are composed of different layers (performing different tasks). The endothelial layer regulates coronary artery size (causing it to expand and contract). The endothelial layer becomes dysfunctional in atherosclerosis and this is quantifiable by administering a substance called acetylcholine and measuring the change in vessel diameter. Acetylcholine is a substance produced naturally within humans and its use to test endothelial function is regarded as the “gold standard” method.
Patients treated with drug eluting stents have been shown to have endothelial dysfunction and this is associated with worse long-term outcomes. There have been some studies in pigs to suggest that drug coated balloons may help preserve endothelial function and therefore be associated with better outcomes.
We will look at patients who presented to the Norfolk and Norwich University hospital with heart attacks and have been treated either with the conventional method with drug eluting stents or those who have received the novel drug coated balloon treatment (which has already become established as effective in the treatment of stent restenosis and small coronary arteries). The patients selected will be those who require a repeat angiogram procedure within a certain timeframe of their original intervention. During this angiogram, they will have their coronary artery vessel response measured.REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0204
Date of REC Opinion
21 Jul 2020
REC opinion
Further Information Favourable Opinion