SHINE-CTO
Research type
Research Study
Full title
Sham-Controlled Intervention to Improve Quality of Life in Chronic Total Occlusions
IRAS ID
245263
Contact name
Paul Kelly
Contact email
Sponsor organisation
Basildon and Thurrock University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Does angioplasty for coronary chronic total occlusions improve quality of life?
Coronary chronic total occlusions (CTO) are vessels supplying blood to the heart that are chronically blocked. Nowadays, we can open these vessels with a high procedural success and low complications rates. The main aimed benefit by doing so is to improve patients' quality of life (reduce symptoms and increase exercise capacity). Although in our everyday clinical practice we see a huge benefit in our patients there are limited data (clinical trials) to support this practice.
New medication are usually tested in placebo-controlled trials, where one group of participants is getting the medication and the other is getting a tablet with no effect (placebo). This way researchers aim to diminish any potential inclination or prejudice (bias) for or against the tested medication.We will use the same methodology in elective patients with CTO and stable angina in the SHINE-CTO trial. SHINE-CTO will be a multicentre randomised control trial with recruiting centres in USA and Europe. Participants will be randomised to undergo PCI or a placebo procedure. Both groups will be on optimal medical therapy. Subsequently,we will evaluate symptoms and exercise capacity improvement between the two groups at 3 months. At the end of the evaluation period, participants will be offered PCI if needed.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0170
Date of REC Opinion
6 Aug 2018
REC opinion
Further Information Favourable Opinion