Coronary Artery DiseasePoSTCARDNCT04439643
Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)
An observational study of Coronary Artery Disease, run by Elucid Bioimaging Inc. at 1 site in United States.
Trial summary
Develop time-to-event prediction and plaque phenotype classification models for patients with known or suspected coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- vascuCAP
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2020to 30 Jul 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Reverse chronological, all-comers, design, adjusted for demographic factors
Who may be able to join
- Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease, which was positive for coronary atherosclerotic changes.
- Subject must have been ≥ 18 years of age at the time of the CCTA
Who cannot join
- Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
- CCTA taken less than 3 months after deployment of new scanner
- Subject with insufficient CCTA image quality
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Develop time-to-event prediction and plaque phenotype classification models for patients with known or suspected coronary artery disease.
Read the detailed description
Develop time-to-event prediction and plaque phenotype classification models using plaque morphology and composition assessment of CTA which has been validated by histology, applied to representative cohort of patients. Generalizability of models is enhanced by using validated rather than only raw image inputs. Demographic, clinical, and outcome data is collected for enrolled patients as well as last known well dates.
- Conditions
- Coronary Artery Disease
- Being tested
- vascuCAP
- 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.
vascuCAPDevice
time to event and phenotype classification model
| Study group | Role | What they receive |
|---|---|---|
| Development / training | Selected by stratified partitioning Receives: Device: vascuCAP | |
| Sequestered / test | Selected by stratified partitioning Receives: Device: vascuCAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to adverse outcome
Develop time-to-event model for major adverse cardiac events (MACE) prediction on large retrospective cohort (and enable a prospective collection subsequent to this study). Consistent with this primary endpoint is the evaluation of all imaging-derived data that has a bearing on the diagnosis and prognosis of the subject.
Measured: >= 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start5 Feb 2020
- Primary completion28 Feb 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elucid Bioimaging Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Andrew J. Buckler, MS, Principal investigator, Elucid Bioimaging Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439643
- Sponsor's protocol ID
- PoSTCARD
- Acronym
- PoSTCARD
- Status last verified
- Sep 2023
- First submitted
- 17 Jun 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)
- ClinicalTrials.gov ID
- NCT04439643
- Acronym / sponsor ID
- PoSTCARD / PoSTCARD
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Elucid Bioimaging Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 19 Jun 2020 (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.
Develop time-to-event prediction and plaque phenotype classification models for patients with known or suspected coronary artery disease.
Detailed description
Develop time-to-event prediction and plaque phenotype classification models using plaque morphology and composition assessment of CTA which has been validated by histology, applied to representative cohort of patients. Generalizability of models is enhanced by using validated rather than only raw image inputs. Demographic, clinical, and outcome data is collected for enrolled patients as well as last known well dates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development / training | – | Device: vascuCAPSelected by stratified partitioning |
| Sequestered / test | – | Device: vascuCAPSelected by stratified partitioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Reverse chronological, all-comers, design, adjusted for demographic factors
Key inclusion criteria (2 listed)
- Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease, which was positive for coronary atherosclerotic changes.
- Subject must have been ≥ 18 years of age at the time of the CCTA
Key exclusion criteria (3 listed)
- Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
- CCTA taken less than 3 months after deployment of new scanner
- Subject with insufficient CCTA image quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vascuCAPtime to event and phenotype classification model | Device | Development / training, Sequestered / test |
Primary outcome
Time to adverse outcome
Time frame: >= 2 years
Develop time-to-event model for major adverse cardiac events (MACE) prediction on large retrospective cohort (and enable a prospective collection subsequent to this study). Consistent with this primary endpoint is the evaluation of all imaging-derived data that has a bearing on the diagnosis and prognosis of the subject.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- 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.
Andrew J. Buckler, MS principal investigator
Elucid Bioimaging Inc.
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 Coronary Artery Disease, run by Elucid Bioimaging Inc. at 1 site in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 13 Sep 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to adverse outcome (time frame: >= 2 years). 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 13 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.