IMPACT-CTO II
Research type
Research Study
Full title
The impact of coronary chronic total occlusion percutaneous coronary intervention on culprit vessel physiology
IRAS ID
240138
Contact name
John Davies
Contact email
Sponsor organisation
Basildon and Thurrock University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
CTO PCI (using balloons and stents to treat of coronary arteries which have been blocked for at least 3 months) has been shown to be effective at reducing symptoms of angina (chest pain coming from the heart) and improve quality of life. New methods and equipment in CTO PCI have dramatically increased success rates which are approaching those of standard angioplasty procedures (treating narrowed rather than chronically occluded vessels). However, the outcomes in the long term have not been shown to be as beneficial. There are higher rates of re-narrowing and re-occlusion, the mechanism of which remain poorly understood.
Following successful CTO PCI, a multitude of changes occur within the treated artery. These would be changes in blood flow/pressure, resistance and size of vessel. Chronic occlusion of these vessels means that it can take time for these parameters to normalise, and vessel size increases with improvement in blood flow. These changes take longer to reach a plateau when compared with standard angioplasty.
This study aims to take physiological measurements of pressure, flow, resistance and intracoronary (imaging withn the artery) imaging immediately after successful CTO PCI. We will relate these to each other and to the technique/equipment used to open these vessels, comparing changes in these groups at three months follow up to see if certain techniques can predict outcomes in these patients.
Quality of life measurements, and exercise testing will be carried out to see if there is a relationship between these physiological and anatomical changes with exercise capacity and quality of life.
Results from this study can then be used to design further trials to compare outcomes with various treatment techniques which have become acceptable and widely used in treating CTO vessels to see if there is superiority with using certain methods.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0297
Date of REC Opinion
12 Nov 2018
REC opinion
Further Information Favourable Opinion