Brain, Blood And Clot or Tissue Registry And Collaboration

NCT03153683 | Recruiting

• 1 other identifier: BACTRAC-17-0019-F1V
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed over the course of the study, an estimated 3 years.

Study Arms (1)

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.

Other: Registry

Interventions

Registry OTHER

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

Cerebrovascular procedure patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may not qualify if:

• \. Pregnant or breastfeeding females

Sponsors & Collaborators

• Justin Fraser: lead
• University of Kentucky: collaborator

Study Sites (1)

University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital

Lexington, Kentucky, 40536-0298, United States

RECRUITING

Related Publications (11)

• McLouth CJ, Maglinger B, Frank JA, Hazelwood HS, Harp JP, Cranford W, Pahwa S, Sheikhi L, Dornbos D 3rd, Trout AL, Stowe AM, Fraser JF, Pennypacker KR. The differential proteomic response to ischemic stroke in appalachian subjects treated with mechanical thrombectomy. J Neuroinflammation. 2024 Aug 17;21(1):205. doi: 10.1186/s12974-024-03201-9.

  PMID: 39154085 DERIVED

• Maglinger B, Harp JP, Frank JA, Rupareliya C, McLouth CJ, Pahwa S, Sheikhi L, Dornbos D 3rd, Trout AL, Stowe AM, Fraser JF, Pennypacker KR. Inflammatory-associated proteomic predictors of cognitive outcome in subjects with ELVO treated by mechanical thrombectomy. BMC Neurol. 2023 Jun 6;23(1):214. doi: 10.1186/s12883-023-03253-z.

  PMID: 37280551 DERIVED

• Hazelwood HS, Frank JA, Maglinger B, McLouth CJ, Trout AL, Turchan-Cholewo J, Stowe AM, Pahwa S, Dornbos DL 3rd, Fraser JF, Pennypacker KR. Plasma protein alterations during human large vessel stroke: A controlled comparison study. Neurochem Int. 2022 Nov;160:105421. doi: 10.1016/j.neuint.2022.105421. Epub 2022 Sep 28.

  PMID: 36179808 DERIVED

• Maglinger B, McLouth CJ, Frank JA, Rupareliya C, Sands M, Sheikhi L, Pahwa S, Dornbos D 3rd, Harp JP, Trout AL, Turchan-Cholewo J, Stowe AM, Fraser JF, Pennypacker KR. Influence of BMI on adenosine deaminase and stroke outcomes in mechanical thrombectomy subjects. Brain Behav Immun Health. 2022 Jan 26;20:100422. doi: 10.1016/j.bbih.2022.100422. eCollection 2022 Mar.

  PMID: 35141572 DERIVED

• Spears RC, McLouth CJ, Pennypacker KR, Frank JA, Maglinger B, Martha S, Trout AL, Roberts J, Stowe AM, Sheikhi L, Pahwa S, Fraser JF. Alterations in Local Peri-Infarct Blood Gases in Stroke Patients Undergoing Thrombectomy. World Neurosurg. 2022 Feb;158:e317-e322. doi: 10.1016/j.wneu.2021.10.171. Epub 2021 Oct 30.

  PMID: 34728392 DERIVED

• Sands M, Frank JA, Maglinger B, McLouth CJ, Trout AL, Turchan-Cholewo J, Stowe AM, Fraser JF, Pennypacker KR. Antimicrobial protein REG3A and signaling networks are predictive of stroke outcomes. J Neurochem. 2022 Jan;160(1):100-112. doi: 10.1111/jnc.15520. Epub 2021 Oct 14.

  PMID: 34558059 DERIVED

• Shaw BC, Maglinger GB, Ujas T, Rupareliya C, Fraser JF, Grupke S, Kesler M, Gelderblom M, Pennypacker KR, Turchan-Cholewo J, Stowe AM. Isolation and identification of leukocyte populations in intracranial blood collected during mechanical thrombectomy. J Cereb Blood Flow Metab. 2022 Feb;42(2):280-291. doi: 10.1177/0271678X211028496. Epub 2021 Jul 11.

  PMID: 34250820 DERIVED

• Armstrong GK, Frank JA, McLouth CJ, Stowe A, Roberts JM, Trout AL, Fraser JF, Pennypacker K. Commentary: Use of BACTRAC Proteomic Database-Uromodulin Protein Expression During Ischemic Stroke. J Exp Neurol. 2021 Mar;2(1):29-33.

  PMID: 33768217 DERIVED

• Maglinger B, Frank JA, McLouth CJ, Trout AL, Roberts JM, Grupke S, Turchan-Cholewo J, Stowe AM, Fraser JF, Pennypacker KR. Proteomic changes in intracranial blood during human ischemic stroke. J Neurointerv Surg. 2021 Apr;13(4):395-399. doi: 10.1136/neurintsurg-2020-016118. Epub 2020 Jul 8.

  PMID: 32641418 DERIVED

• Martha SR, Cheng Q, Fraser JF, Gong L, Collier LA, Davis SM, Lukins D, Alhajeri A, Grupke S, Pennypacker KR. Expression of Cytokines and Chemokines as Predictors of Stroke Outcomes in Acute Ischemic Stroke. Front Neurol. 2020 Jan 15;10:1391. doi: 10.3389/fneur.2019.01391. eCollection 2019.

  PMID: 32010048 DERIVED

• Fraser JF, Collier LA, Gorman AA, Martha SR, Salmeron KE, Trout AL, Edwards DN, Davis SM, Lukins DE, Alhajeri A, Grupke S, Roberts JM, Bix GJ, Pennypacker KR. The Blood And Clot Thrombectomy Registry And Collaboration (BACTRAC) protocol: novel method for evaluating human stroke. J Neurointerv Surg. 2019 Mar;11(3):265-270. doi: 10.1136/neurintsurg-2018-014118. Epub 2018 Jul 31.

  PMID: 30064997 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

1 cc of arterial distal blood, thrombus, and 5-10 cc of peripheral arterial blood; biological sample that is procured as part of a normal cerebrovascular procedure and which would otherwise be discarded can be collected under this protocol. Examples include: blood vessels, brain tissue, thrombus tissue, AVM nidus, AVF nidus, resected aneurysm, carotid plaque from CEA, etc.

MeSH Terms

Conditions

Ischemic Stroke; Cerebrovascular Disorders; Ischemia; Stroke

Interventions

Registries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Justin F Fraser, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer R Isaacs, MS, MS

CONTACT

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

Justin F Fraser, MD

CONTACT

859-323-0616; jfr235@uky.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Cerebrovascular, Endovascular, & Skull Base Surgery; Director, Cerebrovascular Surgery; Depts of Neurological Surgery, Neurology, Radiology, and Anatomy & Neurobiology; Center for Advanced Translational Stroke Science; Univ of KY

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 15, 2017
• Study Start: May 11, 2017
• Primary Completion (Estimated): December 28, 2029
• Study Completion (Estimated): December 28, 2029
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)