Brain, Blood And Clot or Tissue Registry And Collaboration
Part of paid clinical trials in Lexington, Kentucky.
- Sponsor
- Justin Fraser
- Study ID
- NCT03153683
- Status
- Recruiting
Conditions
- Acute Ischemic Stroke
- Cerebrovascular Disorders
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Registry — OTHERCollect standard of care clot, tissue and arterial blood during standard of care cerebrovascular procedure for lab analysis.
Study Details
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.
Key Dates
- Start date
- May 11, 2017
- Status verified
- Mar 2026
- Primary completion
- Dec 28, 2029
- Completion
- Dec 28, 2029
Study Design
- Enrollment
- 1,000 participants (estimated)
Arms
- Arm: Cerebrovascular procedure patientsThis is a registry. No above standard of care interventions will take place. Participants must be undergoing a clinically routine cerebrovascular procedure.
Primary Outcome Measure
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. [ Time Frame: Assessed over the course of the study, an estimated 3 years. ]
Central Contacts
- Jennifer R Isaacs, MS, MS859-323-4738
- Justin F Fraser, MD859-323-0616
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital | Lexington | Kentucky | 40536-0298 | - |
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