Computed Tomography AngiographyNCT06498830
Application of CTA-based Radiomic Phenotyping of PCAT and Fluid Dynamics in Atherosclerotic Disease (APPLE)
An observational study of Computed Tomography Angiography and Inflammation of Adipose Tissue, run by Jinling Hospital, China at 1 site in China.
Trial summary
This study (APPLE study) intends to retrospectively enroll more than 2000 patients who who underwent ≥2 coronary computed tomography angiography (CCTA) with ≥3 months interval from 11 hospitals in more than 4 provinces in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Computed Tomography Angiography, Inflammation of Adipose Tissue, CFD
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2023to 30 Dec 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients who underwent serial CCTA (at least 2 times) and enrolled those without plaque at baseline
Who may be able to join
- patients underwent CCTAs at least twice;
- patients without any concomitant obstructive CAD, or any concomitant atherosclerotic lesions in the LAD on the baseline CCTA;
- patients without previous percutaneous coronary intervention or coronary artery bypass grafting, implanted cardiac devices, and anomalous coronary arteries as evidenced by conventional CCTA.
Who cannot join
- image quality of CCTA was inadequate for either MB morphological or FAI or CFD analysis in either cardiac phase;
- patients received other tube voltages except for 100 kVp and 120 kVp;
- the interscan interval between serial CCTAs< 3 months;
- missing CCTA data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Research Institute Of Medical Imaging Jinling Hospital
Nanjing, Jiangsu, 210018
Longjiang Zhang, MD, +8613405833176, kevinzhlj@163.com
About this study
Official title: Application of CTA-based Radiomic Phenotyping of Peri-coronary Adipose Tissue and Fluid Dynamics in Atherosclerotic Disease
This study (APPLE study) intends to retrospectively enroll more than 2000 patients who who underwent ≥2 coronary computed tomography angiography (CCTA) with ≥3 months interval from 11 hospitals in more than 4 provinces in China.
Read the detailed description
A multicenter, retrospective, observational trial will be conducted (APPLE study). To investigate whether a combined model constructed on the basis of pericoronary adipose tissue (PCAT) radiomics, fluid dynamics and clinical risk factors can predict the formation of atherosclerotic plaque. It will be carried out in 11 hospitals in 4 provinces in China. The Boruta algorithm and correlation proof clustering analysis were used to screen the imaging histological features, and a random forest model was used to construct an imaging histological prediction model for PCAT and fluid dynamics and to construct radiomics' score. To investigate the incremental value of the radiomics' score beyond the traditional prediction model, the radiomics' score was combined with the traditional logistic regression prediction model. Receiver operating characteristic (ROC) curve analysis with integrated discrimination improvement (IDI) and category net reclassification index (NRI) were used to compare the performance of the predictive models. A ML-prediction model incorporates FAI, fluid dynamics and patient clinical characteristics to identify high-risk patients in advance for patients receiving routine CCTA and guide the more precise use of preventative treatments, including anti-inflammatory therapies.
- Medical subject headings
- Steatitis
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 |
|---|---|---|
| The formation of any atherosclerotic plaque on the follow-up CCTA | Not described | |
| The regression of any atherosclerotic plaque on the follow-up CCTA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the formation and regression of any atherosclerotic plaque on the follow-up CCTA
the formation and regression of any atherosclerotic plaque (Yes/No)
Measured: 1 day
Secondary outcomes (1)
Total plaque volume
Total plaque volume
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start17 Oct 2023
- Primary completion1 Jul 2024
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computed Tomography AngiographyStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang longjiang,MD, Jinling Hospital, China
- Investigators
- Longjiang Zhang, MD, Study chair, Jinling Hospital, Medical School of Nanjing University, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498830
- Sponsor's protocol ID
- 2023DZKY-124-01
- Status last verified
- Oct 2023
- First submitted
- 6 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of CTA-based Radiomic Phenotyping of Peri-coronary Adipose Tissue and Fluid Dynamics in Atherosclerotic Disease
- ClinicalTrials.gov ID
- NCT06498830
- Acronym / sponsor ID
- 2023DZKY-124-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Jul 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 study (APPLE study) intends to retrospectively enroll more than 2000 patients who who underwent ≥2 coronary computed tomography angiography (CCTA) with ≥3 months interval from 11 hospitals in more than 4 provinces in China.
Detailed description
A multicenter, retrospective, observational trial will be conducted (APPLE study). To investigate whether a combined model constructed on the basis of pericoronary adipose tissue (PCAT) radiomics, fluid dynamics and clinical risk factors can predict the formation of atherosclerotic plaque. It will be carried out in 11 hospitals in 4 provinces in China. The Boruta algorithm and correlation proof clustering analysis were used to screen the imaging histological features, and a random forest model was used to construct an imaging histological prediction model for PCAT and fluid dynamics and to construct radiomics' score. To investigate the incremental value of the radiomics' score beyond the traditional prediction model, the radiomics' score was combined with the traditional logistic regression prediction model. Receiver operating characteristic (ROC) curve analysis with integrated discrimination improvement (IDI) and category net reclassification index (NRI) were used to compare the performance of the predictive models. A ML-prediction model incorporates FAI, fluid dynamics and patient clinical characteristics to identify high-risk patients in advance for patients receiving routine CCTA and guide the more precise use of preventative treatments, including anti-inflammatory therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The formation of any atherosclerotic plaque on the follow-up CCTA | – | – |
| The regression of any atherosclerotic plaque on the follow-up CCTA | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients who underwent serial CCTA (at least 2 times) and enrolled those without plaque at baseline
Key inclusion criteria (3 listed)
- patients underwent CCTAs at least twice;
- patients without any concomitant obstructive CAD, or any concomitant atherosclerotic lesions in the LAD on the baseline CCTA;
- patients without previous percutaneous coronary intervention or coronary artery bypass grafting, implanted cardiac devices, and anomalous coronary arteries as evidenced by conventional CCTA.
Key exclusion criteria (4 listed)
- image quality of CCTA was inadequate for either MB morphological or FAI or CFD analysis in either cardiac phase;
- patients received other tube voltages except for 100 kVp and 120 kVp;
- the interscan interval between serial CCTAs< 3 months;
- missing CCTA data.
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
the formation and regression of any atherosclerotic plaque on the follow-up CCTA
Time frame: 1 day
the formation and regression of any atherosclerotic plaque (Yes/No)
1 secondary outcome
Total plaque volume
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Longjiang Zhang, MD study chair
Jinling Hospital, Medical School of Nanjing University, Nanjing, China
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 Computed Tomography Angiography and Inflammation of Adipose Tissue, run by Jinling Hospital, China 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 3 inclusion and 4 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 12 Jul 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 Longjiang Zhang, MD (+8613405833176 ext. +86, kevinzhlj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the formation and regression of any atherosclerotic plaque on the follow-up CCTA (time frame: 1 day). 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 12 Jul 2024.