Screening Coronary Artery Disease Using artiFicial intelligencE in Non-contrast Computed Tomography — SAFE-CT  

Coronary Artery Disease Clinical Trial

Official title: Screening Coronary Artery Disease Using artiFicial intelligencE in Non-contrast Computed Tomography

Status Not yet recruiting

Clinical Trial Summary

This project aims to improve direct patient care by reducing the risks of futile exposure to ionizing radiation and iodinated contrast in patients referred for coronary computed tomography angiography

Clinical Trial Description

Since the last NICE guidelines update recommending computed tomography coronary angiography (CTCA) as the first line of investigation for patients with suspected coronary artery disease (CAD), there has been a high burden in the healthcare system and unnecessary exposition to radiation and iodine-containing contrast medium, especially in the youngest. Around 35% of patients who currently undergo CTCA have normal coronaries which means those patients were unnecessary exposed to radiation and contrast. A CTCA screening strategy to rule out CAD is needed to comply with the ALARA ("As Low As Reasonable Achievable") principles preventing radiation risks, reducing unnecessary scans and directing healthcare resources to those who will benefit from a CTCA.

We designed the SAFE-CT (Screening coronary Artery disease using artiFicial intelligencE in noncontrast Computed Tomography) study to develop a state-of-art artificial intelligence method to detect CAD as defined on CTCA using high-dimensional data (radiomics) extracted from the non-contrast cardiac computed tomography (CT). The model will be trained in 15,000 subjects scanned with paired non-contrast CT and CTCA and externally validated in an independent cohort of 1,000 subjects. In a preliminary analysis, non-contrast CT radiomics improved calcium score performance and discriminated CAD with an AUC of 0.91 (95% CI: 0.83-1.00). The algorithm will be converted into a user-friendly plugin to automatically decide whether the patient needs contrast. A real-world multicentre cohort study will be planned for software prospective validation and the creation of a large-scale proteomic biobank to support the translation of imaging biomarkers worldwide.

SAFE-CT can change the current CT scanning workflow by creating software that accurately rules out any CAD in >1/3 of patients referred for CTCA with low radiation and no contrast. This accurate machine learning model will be optimized to reach >90% sensitivity and negative predictive value and will bring several advantages for patients and the healthcare system:

• Prevention of radiation and contrast exposition.

• Increased CTCA scanning capacity for complex cases.

• Widespread use of CT for CAD exclusion in the emergency department and in outpatient clinics of centres with no CTCA.

• Improved screening tool for CAD in asymptomatic subjects.

• Up- and downstream cost reduction.

The SAFE-CT project proposes a safer, low-cost, and personalized CTCA scanning strategy that fosters scientific and technological innovation with the potential to bring improvement to patient care and clinical practice, and, thereby, societal, and economic impact. ;

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atheroscleroses
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT06438393
• Study type: Observational
• Source: Universidade do Porto
• Status: Not yet recruiting
• Start date: June 2024
• Completion date: December 2027