CAD - Coronary Artery DiseaseTOCCATANCT06660485
Establishment of a Cohort for Continuous Coronary Artery CTA Scanning and Predictive Analysis of Plaque Progression
An observational study of CAD - Coronary Artery Disease, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CAD - Coronary Artery Disease
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 1 Jul 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have undergone multiple consecutive CCTA examinations.
Who may be able to join
- Patients who have undergone multiple consecutive CCTA examinations.
Who cannot join
- Patients who have undergone only a single CCTA examination. Patients whose CCTA image quality is poor and cannot be analyzed.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital of Sichuan University
Sichuan, Chengdu, 610041
Junyan Zhang, 18848242671, 651874354@qq.com
About this study
Official title: 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.
- Conditions
- CAD - Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Continuous CCTA Scanning Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 year
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD - Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong He, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660485
- Sponsor's protocol ID
- WestChinaH-CVD-007
- Acronym
- TOCCATA
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Cohort for ConTinuous COronary CTA SCanning And PredicTive Analysis of Plaque Progression (TOCCATA)
- ClinicalTrials.gov ID
- NCT06660485
- Acronym / sponsor ID
- TOCCATA / WestChinaH-CVD-007
- Conditions
- CAD - Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous CCTA Scanning Cohort | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have undergone multiple consecutive CCTA examinations.
Key inclusion criteria (1 listed)
- Patients who have undergone multiple consecutive CCTA examinations.
Key exclusion criteria (1 listed)
- Patients who have undergone only a single CCTA examination. Patients whose CCTA image quality is poor and cannot be analyzed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum Coronary Stenosis (MAXS)
Time frame: 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.
2 secondary outcomes
Cumulative Coronary Stenosis (SIS):
Time frame: 2 year
Segment Involvement Score (SSS):
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CAD - Coronary Artery Disease, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong He, MD (18980602038, heyongmd@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Coronary Stenosis (MAXS) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.