Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-27
Brief Title:
Screening Coronary Artery Disease Using artiFicial intelligencE in Non-contrast Computed Tomography
Sponsor:
Universidade do Porto
Organization:
Universidade do Porto
Study Overview
Official Title:
Screening Coronary Artery Disease Using artiFicial intelligencE in Non-contrast Computed Tomography
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFE-CT
Brief 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
Detailed 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 15000 subjects scanned with paired non-contrast CT and CTCA and externally validated in an independent cohort of 1000 subjects In a preliminary analysis non-contrast CT radiomics improved calcium score performance and discriminated CAD with an AUC of 091 95 CI 083-100 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 13 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
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 15000 subjects scanned with paired non-contrast CT and CTCA and externally validated in an independent cohort of 1000 subjects In a preliminary analysis non-contrast CT radiomics improved calcium score performance and discriminated CAD with an AUC of 091 95 CI 083-100 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 13 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None