The PRECISE study
Research type
Research Study
Full title
The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
IRAS ID
255538
Contact name
John Greenwood
Contact email
Sponsor organisation
HeartFlow, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
Coronary artery disease (CAD) is a common diagnosis worldwide and results in significant morbidity and mortality. The common presentations and symptoms can be diagnostically puzzling and often require diagnostic testing or angiography to be certain of the diagnosis and treatment. The current guidelines recommend risk evaluation before opting for non-invasive or invasive tests. However, the results of using these recommended strategies are unsatisfactory causing high costs without accompanying benefit.The goal of this study is to define the optimal evaluation and management strategy for participants with suspected CAD by comparing a precision evaluation strategy to a usual care strategy. The study will be a randomised clinical trial where the eligible participants will be randomised into two groups; precision and usual care group. Participants in the precision group will be categorised based on the score obtained by the validated PROMISE risk assessment tool where the low-risk group will be assigned guideline recommended care and the rest will be evaluated with cCTA (imaging method)and selective FFRCT (non invasive technique that uses cCTA images). Whereas, the participants in the usual care arm will receive a standard of care non-invasive or invasive test . The study will enrol approximately 2100 participants across the US, Canada and EU at approximately 100 sites. The participants will be in the study for 2 years and are expected to visit the study centre for approximately 6 times during the study period. Alternatively, some of these visits meant for follow up can be conducted over the phone.
Summary of results
The PRECISE trial found the ‘Precision Strategy (PS)’(CCTA ± FFRCT-centered diagnostic strategy to determine the cause of chest pain and/or other cardiac-related symptoms) to be superior diagnostic pathway over ‘Usual Testing (UT)’ (exercise electrocardiogram, stress echocardiogram, stress nuclear myocardial perfusion imaging (single-photon emission CT or positron emission tomography(PET)), stress cardiovascular magnetic resonance imaging(MRI), or invasive cardiac catheterization) for patients with suspected coronary artery disease.
Trial results showed that (1) PS allows for more accurate non-invasive diagnosis, significantly lowering the rates of false negatives and false positives compared to UT in patients with coronary artery disease - 78% more likely to identify patients in need for revascularization; (2) Reduces unnecessary tests, providing a better patient experience, with a 4x reduction in unnecessary invasive catheterization and necessitating fewer initial diagnostic tests overall; (3) Provides confidence in treating the right patients - 75% more likely to identify patients in need of intervention.
The PRECISE Trial results were published in JAMA Cardiology.REC name
London - Stanmore Research Ethics Committee
REC reference
19/LO/0343
Date of REC Opinion
9 Aug 2019
REC opinion
Further Information Favourable Opinion