Establishment of a Cohort for Continuous Coronary Artery CTA Scanning and Predictive Analysis of Plaque Progression (TOCCATA)

Establishment of a Cohort for ConTinuous COronary CTA SCanning And PredicTive Analysis of Plaque Progression (TOCCATA)

This research develops risk prediction models for coronary artery stenosis and vulnerable plaques. The coronary artery stenosis model aims to predict stenosis using multimodal deep learning by integrating text, structured numerical data, and imaging features, focusing on metrics like maximum and cumulative stenosis. The vulnerable plaque model seeks to identify early formation indicators, allowing for timely interventions to prevent plaque rupture, using similar data integration techniques. Additionally, a decision support system is created, comprising a patient database, risk prediction models, and a high-risk alert module. This system facilitates real-time notifications to healthcare providers when risk thresholds are exceeded, enabling personalized treatment planning and improved patient outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: CAD - Coronary Artery Disease

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Yong He, MD; Phone Number: 18980602038; Email: heyongmd@wchscu.cn

Study Locations

• China
  • Chengdu
    • Sichuan, Chengdu, China, 610041
      • West China Hospital of Sichuan University
      • Contact: Junyan Zhang; Phone Number: 18848242671; Email: 651874354@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone multiple consecutive CCTA examinations.

Description

Inclusion Criteria:

Patients who have undergone multiple consecutive CCTA examinations.

Exclusion Criteria:

Patients who have undergone only a single CCTA examination. Patients whose CCTA image quality is poor and cannot be analyzed.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Continuous CCTA Scanning Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Coronary Stenosis (MAXS)	In 18 vascular segments, each segment is scored based on the degree of stenosis. The scoring criteria are as follows: no stenosis (0%) is scored as 0 points, mild stenosis (1%-24%) is scored as 1 point, moderate stenosis (25%-49%) is scored as 2 points, significant stenosis (50%-69%) is scored as 3 points, severe stenosis (70%-99%) is scored as 4 points, and total occlusion (100%) is scored as 5 points. MAXS represents the score of the single segment with the highest score among the 18 vascular segments.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Coronary Stenosis (SIS):	Each segment with a lesion among the 18 vascular segments is assigned a score of 1 point. If a segment does not have a lesion, it is scored as 0 points. The total score of SIS is the sum of the scores of all vascular segments with lesions.	2 year
Segment Involvement Score (SSS):	First, each lesion is scored based on its degree of stenosis, using the same scoring criteria as MAXS. Then, the scores of each lesion are accumulated based on their degree of stenosis (no stenosis is 0 points, mild stenosis is 1 point, moderate stenosis is 2 points, significant stenosis is 3 points, severe stenosis is 4 points, and total occlusion is 5 points). Finally, the scores of the 18 vascular segments are summed to obtain SSS.	2 year

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Ischemia; Coronary Artery Disease; Coronary Disease
• Other Study ID Numbers: WestChinaH-CVD-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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