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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Registry — OTHER
    Collect 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 patients
    This 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kentucky Deparment of Neurosurgery, UK Chandler HospitalLexingtonKentucky40536-0298-

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