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

Not yet recruiting

• Conditions: CAD - Coronary Artery Disease

• Registration Number: NCT06660485
• Lead Sponsor: West China Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Study Start: 2024-10-30
• Primary Completion: 2026-03-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum Coronary Stenosis (MAXS)	2 year	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.

Secondary Outcome Measures

Name	Time	Method
Cumulative Coronary Stenosis (SIS):	2 year	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.
Segment Involvement Score (SSS):	2 year	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.

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Sichuan, Chengdu, China