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

NCT06660485 | Not Yet Recruiting

• 1 other identifier: WestChinaH-CVD-007
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

CAD - Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cumulative Coronary Stenosis (SIS):

  2 year

• Segment Involvement Score (SSS):

  2 year

Study Arms (1)

Continuous CCTA Scanning Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone multiple consecutive CCTA examinations.

You may qualify if:

• Patients who have undergone multiple consecutive CCTA examinations.

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Sichuan, Chengdu, 610041, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Yong He, MD

CONTACT

18980602038; heyongmd@wchscu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 28, 2024
• Study Start: October 30, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

CN (1)