An observational study in Acute Ischemic Stroke and Cerebrovascular Disorders, sponsored by Justin Fraser. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Justin Fraser · Observational
This is a prospective open enrollment biorepository to collect and evaluate blood and tissue collected during cerebrovascular procedures, which will then be used for the purposes of identifying biological markers, inflammatory cell infiltrates, and biological states in stroke and other cerebrovascular diseases in the human condition.
The study population will include up to 1000 subjects with cerebrovascular disease or suspected cerebrovascular disease. Male and female participants 18 years of age and older will be enrolled.
This protocol covers the procurement of biological samples from patients undergoing any cerebrovascular surgery and/or neurointerventional clinical procedure at University of Kentucky. Control participants will include patients undergoing non-emergent, elective diagnostic cerebral angiography as well as patients undergoing emergent angiogram cases.
This study represents the first time that tissue, clot and blood will be evaluated for the markers, proteins, and cytokines in human subjects undergoing cerebrovascular procedures.
By starting with the human condition, the investigators aim to minimize this loss in translation. Overall, this study will have a great impact on our knowledge of stroke pathology. In essence, this could fundamentally change not only how the investigators develop treatment strategies for the stroke patient population but allow us to individualize the treatment dependent on time after stroke, age, sex, and co-morbidities. Molecular techniques that are impractical when delivered systemically could be delivered locally to impede the early inflammation.
This research aims to advance understanding of cerebrovascular disease and to support the development of improved therapies.
This is a prospective open enrollment biorepository to collect and evaluate blood and tissue collected during cerebrovascular procedures, which will then be used for the purposes of identifying biological markers, inflammatory cell infiltrates, and biological states in stroke and other cerebrovascular diseases in the human condition.
This research aims to advance understanding of cerebrovascular disease and to support the development of improved therapies.
The study population will include up to 1000 subjects with cerebrovascular disease or suspected cerebrovascular disease. Male and female participants 18 years of age and older will be enrolled.
Participants will be recruited from patients evaluated at University of Kentucky Chandler Hospital for cerebrovascular procedures . Participants with impaired capacity may be included as the pathology to be studied may impair their capacity.
The primary endpoints of the study will be evaluation of specific proteins and leukocyte populations in the human stroke clot, tissues and blood.
The following describes all study procedures and evaluations that are to be done as part of the study.
Baseline:
Data points recorded may include:
Study Specimen Collection
This protocol covers the procurement of tissue samples, blood samples, and other biological samples from patients undergoing any cerebrovascular surgery and/or clinical procedure.
Any tissue or biological sample that is procured as part of a normal cerebrovascular procedures and which would otherwise be discarded can be collected under this protocol. Examples of these tissue samples include:
Peripheral blood samples may also be collected from patients. These are the only biospecimens that will be procured specifically for this research and that are not collected as part of normal cardiac care. These samples will consist of 5 to 10 cc of peripheral blood and may be collected:
The study population will include up to 1000 subjects with cerebrovascular disease or suspected cerebrovascular disease. Male and female participants 18 years of age and older will be enrolled.
This protocol covers the procurement of biological samples from patients undergoing any cerebrovascular surgery and/or neurointerventional clinical procedure at University of Kentucky.
Inclusion Criteria 1. All patients, Male or female, aged 18 years or older, undergoing cerebrovascular surgery/procedure at the University of Kentucky.
Exclusion Criteria:
1. Pregnant or breastfeeding females
This is a registry. No above standard of care interventions will take place. Participants must be undergoing a clinically routine cerebrovascular procedure.
Other: Registry
Collect standard of care clot, tissue and arterial blood during standard of care cerebrovascular procedure for lab analysis.
Evaluate pH of blood as a marker of acid/base balance in distal blood and proximal blood, and correlate to interval of time between Last Known Normal and vessel recanalization.
A small amount of blood (from the two specimens) will be sent for blood gas analysis to evaluate the pH, pO2, pCO2, pHCO3 potassium, sodium, and calcium concentrations.
Time frame: Assessed over the course of the study, an estimated 3 years.
Plan to share: Undecided — To be announced.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Justin Fraser