Recruiting

Cerebrovascular Disease

Sponsor:

Justin Fraser

Code:

NCT03153683

Conditions

Acute Ischemic Stroke

Cerebrovascular Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Registry

Study Details

Brief summary:

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.

Conditions

Acute Ischemic Stroke

Cerebrovascular Disorders

Study ID

NCT03153683

Start date

May 11, 2017

Status verified date

Mar, 2026

Completion date

Dec 28, 2029

Anticipated

Primary completion date

Dec 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Registry

Collect standard of care clot, tissue and arterial blood during standard of care cerebrovascular procedure for lab analysis.

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 and Locations

Central contacts

Jennifer R Isaacs, MS, MS

859-323-4738jennifer.isaacs@uky.edu

Justin F Fraser, MD

859-323-0616jfr235@uky.edu

Locations

University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital

Recruiting

Lexington, Kentucky, United States, 40536-0298

More Information

Sponsor

Justin Fraser

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • Acute
  • Ischemic
  • Stroke
  • Biomarkers
  • Proteins
  • Inflammatory Cells
  • Acid/Base Balance
  • cerebrovascular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Justin Fraser on 2026-03-04.