Carotid AtherosclerosisCRISPNCT04448353
Carotid Risk Prediction (CRISP) Consortium
An observational study of Carotid Atherosclerosis, run by Elucid Bioimaging Inc. at 5 sites in United States.
Trial summary
Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid 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
- Carotid Atherosclerosis
- What is being tested?
- vascuCAP
- How many people
- 800 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Mar 2019to 30 Apr 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: All-comers, design, adjusted for demographic factors
Who may be able to join
- Subjects must have two (or more) neck CTAs at least 6 months apart of sufficient quality as documented in the vascuCAP Reading Manual.
- Atherosclerotic plaque must be visualized within the carotid artery.
Who cannot join
- Subjects without visible plaque within the carotid artery
- Subject with insufficient CTA image quality (defined strictly as documented in the vascuCAP Reading Manual)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Baltimore VA Medical Center
Baltimore, Maryland, 21201
Brajesh K Lal, MD, 410-328-5840, blal@som.umaryland.edu
- Recruiting
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Brajesh K Lal, MD, 410-328-5840, blal@som.umaryland.edu
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Kevin DeMarco, MD, 301-295-4428, james.k.demarco.civ@mail.mil
- Recruiting
University Hospital Harrington (Affiliated with Case Western Reserve University)
Cleveland, Ohio, 44106
Vikram Kashyap, MD, 216-250-9840, vikram.kashyap@uhhospitals.org
- Recruiting
Weill Cornell Medicine (Affiliated with New York Presbyterian Hospital)
New York, New York, 10065
Ajay Gupta, MD, 212-746-6000, ajg9004@med.cornell.edu
About this study
Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.
Read the detailed description
Develop adverse 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 information on events and interventions.
- Conditions
- Carotid Atherosclerosis
- Being tested
- vascuCAP
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascuCAPDiagnostic test
adverse event and phenotype classification model
| Study group | Role | What they receive |
|---|---|---|
| Development / training | Selected by stratified partitioning Receives: Diagnostic Test: vascuCAP | |
| Sequestered / test | Selected by stratified partitioning Receives: Diagnostic Test: vascuCAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse outcome model performance
Develop adverse event model for major adverse neurological events (MANE) 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 posted25 Jun 2020
- Study start1 Mar 2019
- Primary completion15 Dec 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid AtherosclerosisStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Elucid Bioimaging Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, College Park
- Responsible party
- Sponsor
- Investigators
- Brajesh K. Lal, MD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448353
- Sponsor's protocol ID
- CRISP
- Acronym
- CRISP
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lal BK, Khan AA, Kashyap VS, Chrencik MT, Gupta A, King AH, Patel JB, Martinez-Delcid J, Uceda D, Desikan S, Sikdar S, Sorkin JD, Buckler A. Computed tomography angiographic biomarkers help identify vulnerable carotid artery plaque. J Vasc Surg. 2022 Apr;75(4):1311-1322.e3. doi: 10.1016/j.jvs.2021.10.056. Epub 2021 Nov 15.
PubMed 34793923
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Risk Prediction (CRISP) Consortium
- ClinicalTrials.gov ID
- NCT04448353
- Acronym / sponsor ID
- CRISP / CRISP
- Conditions
- Carotid Atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Elucid Bioimaging Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, College Park
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 25 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 adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.
Detailed description
Develop adverse 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 information on events and interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development / training | – | Diagnostic Test: vascuCAPSelected by stratified partitioning |
| Sequestered / test | – | Diagnostic Test: vascuCAPSelected by stratified partitioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers, design, adjusted for demographic factors
Key inclusion criteria (2 listed)
- Subjects must have two (or more) neck CTAs at least 6 months apart of sufficient quality as documented in the vascuCAP Reading Manual.
- Atherosclerotic plaque must be visualized within the carotid artery.
Key exclusion criteria (2 listed)
- Subjects without visible plaque within the carotid artery
- Subject with insufficient CTA image quality (defined strictly as documented in the vascuCAP Reading Manual)
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 |
|---|---|---|
| vascuCAPadverse event and phenotype classification model | Diagnostic test | Development / training, Sequestered / test |
Primary outcome
Adverse outcome model performance
Time frame: 2 years
Develop adverse event model for major adverse neurological events (MANE) 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 34793923Lal BK, Khan AA, Kashyap VS, Chrencik MT, Gupta A, King AH, Patel JB, Martinez-Delcid J, Uceda D, Desikan S, Sikdar S, Sorkin JD, Buckler A. Computed tomography angiographic biomarkers help identify vulnerable carotid artery plaque. J Vasc Surg. 2022 Apr;75(4):1311-1322.e3. doi: 10.1016/j.jvs.2021.10.056. Epub 2021 Nov 15.
- 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.
Brajesh K. Lal, MD principal investigator
University of Maryland, College Park
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Atherosclerosis, run by Elucid Bioimaging Inc. at 5 sites 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 2 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew J Buckler, MS (9784731986, andrew.buckler@elucidbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse outcome model performance (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448353, which also lists 1 linked publication.
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 4 Feb 2021.