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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06660485
Acronym
TOCCATA
Enrollment
5000
Registered
2024-10-28
Start date
2024-10-30
Completion date
2026-07-01
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CAD - Coronary Artery Disease

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.

Interventions

None listed

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Maximum Coronary Stenosis (MAXS)2 yearIn 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

MeasureTime frameDescription
Cumulative Coronary Stenosis (SIS):2 yearEach 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 yearFirst, 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.

Countries

China

Contacts

Primary ContactYong He, MD
heyongmd@wchscu.cn18980602038

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026