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

Application of CTA-based Radiomic Phenotyping of Peri-coronary Adipose Tissue and Fluid Dynamics in Atherosclerotic Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Computed Tomography Angiography; CFD; Inflammation of Adipose Tissue

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Longjiang Zhang, MD; Phone Number: +86 +8613405833176; Email: kevinzhlj@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210018
      • Recruiting
      • Research Institute Of Medical Imaging Jinling Hospital
      • Contact: Longjiang Zhang, MD; Phone Number: +8613405833176; Email: kevinzhlj@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients who underwent serial CCTA (at least 2 times) and enrolled those without plaque at baseline

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
The formation of any atherosclerotic plaque on the follow-up CCTA
The regression of any atherosclerotic plaque on the follow-up CCTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the formation and regression of any atherosclerotic plaque on the follow-up CCTA	the formation and regression of any atherosclerotic plaque (Yes/No)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total plaque volume	Total plaque volume	1 day

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Study Chair: Longjiang Zhang, MD, Jinling Hospital, Medical School of Nanjing University, Nanjing, China

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 6, 2024
• First Submitted That Met QC Criteria: July 6, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 6, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Nutrition Disorders; Connective Tissue Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin E Deficiency; Inflammation; Panniculitis; Steatitis
• Other Study ID Numbers: 2023DZKY-124-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No