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| Name | Class |
|---|---|
| University of Maryland, College Park | OTHER |
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Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Development / training | Selected by stratified partitioning |
| |
| Sequestered / test | Selected by stratified partitioning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vascuCAP | Diagnostic Test | adverse event and phenotype classification model |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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All-comers, design, adjusted for demographic factors
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew J Buckler, MS | Contact | 9784731986 | andrew.buckler@elucidbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Brajesh K. Lal, MD | University of Maryland, College Park | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center | Recruiting | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34793923 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 29, 2022 | |
| Reset | Aug 9, 2022 | |
| Release | Aug 9, 2022 | |
| Reset | Jul 6, 2023 | |
| Release | Sep 8, 2023 | |
| Reset | Mar 20, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 29, 2022 | Aug 9, 2022 | |||
| Aug 9, 2022 |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| University of Maryland, Baltimore | Recruiting | Baltimore | Maryland | 21201 | United States |
|
| Walter Reed National Military Medical Center | Recruiting | Bethesda | Maryland | 20814 | United States |
|
| Weill Cornell Medicine (Affiliated with New York Presbyterian Hospital) | Recruiting | New York | New York | 10065 | United States |
|
| University Hospital Harrington (Affiliated with Case Western Reserve University) | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| Jul 6, 2023 |
| Sep 8, 2023 | Mar 20, 2024 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |