Application of CTA-based Radiomic Phenotyping of PCAT and Fluid Dynamics in Atherosclerotic Disease (APPLE)

NCT ID: NCT06498830

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2024-12-30

Brief Summary

This study (APPLE study) intends to retrospectively enroll more than 2000 patients who who underwent ≥2 coronary computed tomography angiography (CCTA) with ≥3 months interval from 11 hospitals in more than 4 provinces in China.

Detailed Description

A multicenter, retrospective, observational trial will be conducted (APPLE study). To investigate whether a combined model constructed on the basis of pericoronary adipose tissue (PCAT) radiomics, fluid dynamics and clinical risk factors can predict the formation of atherosclerotic plaque. It will be carried out in 11 hospitals in 4 provinces in China. The Boruta algorithm and correlation proof clustering analysis were used to screen the imaging histological features, and a random forest model was used to construct an imaging histological prediction model for PCAT and fluid dynamics and to construct radiomics' score. To investigate the incremental value of the radiomics' score beyond the traditional prediction model, the radiomics' score was combined with the traditional logistic regression prediction model. Receiver operating characteristic (ROC) curve analysis with integrated discrimination improvement (IDI) and category net reclassification index (NRI) were used to compare the performance of the predictive models. A ML-prediction model incorporates FAI, fluid dynamics and patient clinical characteristics to identify high-risk patients in advance for patients receiving routine CCTA and guide the more precise use of preventative treatments, including anti-inflammatory therapies.

Conditions

Computed Tomography Angiography; Inflammation of Adipose Tissue; CFD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

The formation of any atherosclerotic plaque on the follow-up CCTA

No interventions assigned to this group

The regression of any atherosclerotic plaque on the follow-up CCTA

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Zhang longjiang,MD

Head of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Longjiang Zhang, MD

Role: STUDY_CHAIR

Jinling Hospital, Medical School of Nanjing University, Nanjing, China

Locations

Research Institute Of Medical Imaging Jinling Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Longjiang Zhang, MD

Role: CONTACT

kevinzhlj@163.com

+8613405833176 ext. +86

Facility Contacts

Longjiang Zhang, MD

Role: primary

kevinzhlj@163.com

+8613405833176

Other Identifiers

2023DZKY-124-01

Identifier Type: -

Identifier Source: org_study_id