The OPTIMAL Trial
Research type
Research Study
Full title
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium
IRAS ID
366828
Contact name
Daniel Jones
Contact email
Sponsor organisation
EPIC Foundation
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Coronary artery disease is caused by narrowing of the blood vessels that supply the heart. In many patients, these narrowings contain calcium, which makes treatment more difficult. When calcium is present, it can prevent heart stents from expanding properly, increasing the risk of future problems such as repeat procedures, heart attacks, or stent blockage.
The OPTIMAL Trial, is a prospective, randomised controlled trial designed to compare two different imaging strategies used to guide the treatment of calcified coronary artery disease during a stent procedure (also known as percutaneous coronary intervention or PCI). The current standard approach uses a small ultrasound probe inside the blood vessel (intravascular ultrasound, IVUS) during the procedure to assess calcium and guide treatment. The alternative approach being studied uses information from a heart CT scan (coronary CT angiography, CCTA) performed before the procedure to plan how best to treat the calcium.
Patients who have significant narrowing of a heart artery with calcium, identified on a CT scan, and who have a clinical indication for a stent procedure will be invited to take part. Participants will be randomly allocated to one of two groups. One group will have their calcium treatment guided by the CT scan findings, while the other group will have calcium treatment guided by IVUS. Both will have IVUS performed at the end.
The study will enrol 700 patients from hospitals in the United Kingdom, Europe, and the United States. Participants will be followed for 12 months after their procedure. The study will assess whether the CT-guided approach leads to better stent expansion and whether it is as safe and effective as the standard IVUS-guided approach in terms of major heart-related events. The results may help improve how stent procedures are planned and performed for patients with calcified coronary artery disease.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
26/EM/0084
Date of REC Opinion
12 May 2026
REC opinion
Further Information Favourable Opinion