HeartFlow initiates PRECISE randomised clinical trial

HeartFlow Analysis

HeartFlow has announced the start of the PRECISE (Prospective randomised trial of the optimal evaluation of cardiac symptoms and revascularisation trial). The first patient was enrolled by Michael C Turner, (Imperial Health Cardiovascular Specialists, Lake Charles, USA).

The PRECISE trial is designed to compare the usual approach of diagnosing and evaluating patients with stable chest pain using a stress test and/or invasive cardiac catheterisation to a new precision evaluation strategy using risk-based testing and coronary computed tomography (CT) angiography scans. The PRECISE trial will evaluate whether the new approach can improve the accuracy, outcomes, efficiency, and cost of diagnosing and caring for patients with suspected coronary artery disease. The trial will enrol more than 2,000 patients from approximately 100 centres around the world.

In the PRECISE trial, patients will be randomised to either the usual care or precision evaluation strategy arm. Patients in the precise arm will be assessed using the PROMISE risk score and placed in either a low/no risk group or the intermediate/high risk group. Patients in the low/no risk group will be treated with medications and lifestyle modifications. All patients in the intermediate/high risk group will undergo a CT angiography. When additional information is needed, a HeartFlow FFRct Analysis will be conducted.

Pamela Douglas (the Ursula Geller Professor for Research in Cardiovascular Disease, Duke University School of Medicine, Durham, USA), study chair of the PRECISE trial, says: “The impact of coronary artery disease is enormous. It remains the number one cause of death worldwide. Yet, current testing options for suspected heart disease are imperfect, leading to inaccurate diagnoses and the need for additional, often invasive, testing. With the PRECISE trial, we aim to help clinicians diagnose patients with suspected coronary artery disease more efficiently by identifying patients who can be managed medically versus those who require further invasive assessment, while reducing the number, risks and costs of unnecessary tests and procedures.”

A press release reports that the HeartFlow Analysis is a non-invasive, personalised cardiac test that applies artificial intelligence to image data taken from a standard CT angiography scan to create a digital 3D model of the patient’s arteries. It then applies advanced algorithms to solve millions of complex equations to assess the impact any blockages have on blood flow to the heart. The HeartFlow Analysis is provided via a secure online interface to offer actionable information to enable clinicians to determine the optimal course of treatment.

Campbell Rogers, chief medical officer, HeartFlow, comments: “The HeartFlow Analysis provides physicians with a more complete picture and actionable information than any other non-invasive test, and can play an important role in helping physicians diagnose patients with suspected coronary artery disease. Our company is rooted in scientific evidence and the PRECISE trial is the latest example of the company’s ongoing commitment to bringing the very best clinically useful research to our physicians and patients.”


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