Using imaging techniques to predict atherosclerotic plaque formation
Application of CTA-based Radiomic Phenotyping of Peri-coronary Adipose Tissue and Fluid Dynamics in Atherosclerotic Disease
This study is testing if a new method using imaging and patient data can help predict who is at risk of developing harmful plaque in their arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jinling Hospital, China Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06498830 on ClinicalTrials.gov |
What this trial studies
The APPLE study is a multicenter, retrospective observational trial that aims to enroll over 2000 patients who have undergone at least two coronary computed tomography angiographies (CCTA) with a minimum of three months between scans. The study investigates whether a predictive model combining pericoronary adipose tissue (PCAT) radiomics, fluid dynamics, and clinical risk factors can effectively forecast the development of atherosclerotic plaque. Utilizing advanced algorithms and machine learning techniques, the study seeks to enhance traditional prediction models and identify high-risk patients for targeted preventative treatments. The research will be conducted across 11 hospitals in four provinces in China.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone at least two CCTAs without obstructive coronary artery disease or prior coronary interventions.
Not a fit: Patients with inadequate image quality for analysis or those who have undergone previous coronary interventions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and prevention of atherosclerotic plaque formation, potentially reducing cardiovascular events in at-risk patients.
How similar studies have performed: While similar predictive modeling approaches have been explored, this specific combination of PCAT radiomics and fluid dynamics in a multicenter setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients underwent CCTAs at least twice; * patients without any concomitant obstructive CAD, or any concomitant atherosclerotic lesions in the LAD on the baseline CCTA; * patients without previous percutaneous coronary intervention or coronary artery bypass grafting, implanted cardiac devices, and anomalous coronary arteries as evidenced by conventional CCTA. Exclusion Criteria: * image quality of CCTA was inadequate for either MB morphological or FAI or CFD analysis in either cardiac phase; * patients received other tube voltages except for 100 kVp and 120 kVp; * the interscan interval between serial CCTAs\< 3 months; * missing CCTA data.
Where this trial is running
Nanjing, Jiangsu
- Research Institute Of Medical Imaging Jinling Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Longjiang Zhang, MD
- Email: kevinzhlj@163.com
- Phone: +8613405833176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.