Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque
Launched by GE HEALTHCARE · Dec 15, 2023
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new computer-based technology that helps doctors evaluate the safety of heart artery blockages, also known as coronary plaques. The goal is to see how accurately this technology can identify these plaques and determine how risky they are for patients with conditions like chronic coronary syndrome, stable angina, or acute coronary syndrome. By using this technology, doctors hope to improve the way they assess heart health without needing to perform invasive procedures.
To participate in the trial, patients need to be referred for specific heart imaging tests and meet certain requirements, such as having a diagnosis of chronic coronary syndrome or related heart conditions. However, there are some reasons a person might not be eligible, like having a high body mass index or certain heart conditions. While the trial is not currently recruiting, once it begins, participants will likely undergo imaging tests and be monitored to help researchers understand the effectiveness of this new technology. This study is important because it could lead to better, less invasive ways to assess heart health in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Patients referred for a clinically indicated CCTA and ICA with OCT imaging examinations;
- • 2. Diagnosis of chronic coronary syndrome, known CAD, or stable angina; AND,
- • 3. Patients with ACS that may undergo a CCTA and not refer directly to the Cath lab for revascularization procedures.
- Exclusion Criteria:
- • 1. Contradictions to contrast;
- • 2. Contraindications for beta blocker;
- • 3. BMI \>30;
- • 4. High heart rate ≥75 BPM;
- • 5. Atrial Fibrillation;
- • 6. Arrythmia or irregular heartbeats;
- • 7. Any prior coronary revascularization;
- • 8. Presence of pacemaker or implantable cardioverter defibrillator; OR,
- • 9. Patients with TAVI/TAVR.
About Ge Healthcare
GE Healthcare is a leading global medical technology and digital solutions innovator, dedicated to improving patient outcomes through advanced imaging, monitoring, and diagnostics. With a commitment to enhancing healthcare delivery, GE Healthcare develops cutting-edge technologies and clinical applications that empower healthcare professionals to make informed decisions. By leveraging extensive research and development capabilities, the organization actively sponsors clinical trials aimed at validating new therapies and medical devices, ensuring that they meet the highest standards of safety and efficacy. Through collaboration with healthcare providers and institutions, GE Healthcare strives to drive innovation and improve the efficiency of healthcare systems worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pavia, Lombardy, Italy
Patients applied
Trial Officials
Paul Deak
Study Director
GE Healthcare
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported