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Acute Ischemic StrokeBACTRACNCT03153683

Brain, Blood And Clot or Tissue Registry And Collaboration

An observational study of Acute Ischemic Stroke and Cerebrovascular Disorders, run by Justin Fraser at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Registry
How many people
1,000 participants
Where
1 siteUnited States
Study dates
11 May 2017to 28 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

None listed.

Who cannot join

  • 1. Pregnant or breastfeeding females

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer R Isaacs, MS, MS contact

859-323-4738

jennifer.isaacs@uky.edu

Justin F Fraser, MD contact

859-323-0616

jfr235@uky.edu

United States1 site, 1 recruiting
  • University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital

    Lexington, Kentucky, 40536-0298

    Recruiting

Other trials in United States

About this study

Official title: Brain, Blood And Clot or Tissue Registry And Collaboration (BACTRAC)

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.

Read more

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.

Read the detailed description

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:

  • Verify inclusion/exclusion criteria
  • Obtain consent from the patient or Legally Authorized Representative (LAR).
  • Medical history taken from medical record, participant and family to determine eligibility based on inclusion/exclusion criteria (Standard of Care)
  • Medication history (Standard of Care)
  • Baseline physical examination to include vital signs (Standard of Care)
  • Premorbid Modified Ranking Score (mRS)
  • NIH Stroke Scale (Standard of Care)
  • BMI (Standard of Care)
  • Cerebrovascular procedure (Standard of Care)
  • Study Specimen Collection

Data points recorded may include:

  • concomitant medications
  • the vessel location of the thrombus or disease
  • the time from Last Known Normal to vessel recanalization
  • the TICI score
  • the CTA collateral score at presentation
  • the baseline serum bicarbonate
  • the baseline O2 saturation
  • Medical history /co-morbid conditions

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:

  • Blood vessels (arterial or venous)
  • Brain tissue
  • Thrombus tissue
  • AVM nidus from resection
  • AVF nidus from resection
  • Aneurysms if resected
  • Carotid stenosis plaques from CEA

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:

  • Prior to procedure
  • Immediately after procedure
  • At different time intervals after the procedure during the hospital stay. These samples will not exceed the frequency and volume limits detailed in the IRB regulations
  • At the outpatient follow-up after procedure
  • Annually at an office-visit
  • Upon readmission if hospitalized
Being tested
Registry
Keywords
Acute, Ischemic, Stroke, Biomarkers, Proteins, Inflammatory Cells, Acid/Base Balance, cerebrovascular
Medical subject headings
Ischemic Stroke, Cerebrovascular Disorders, Ischemia, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RegistryOther

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

Study groups in NCT03153683
Study groupRoleWhat they receive
Cerebrovascular procedure patientsThis is a registry. No above standard of care interventions will take place. Participants must be undergoing a clinically routine cerebrovascular procedure.
Receives: Other: Registry

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2017
  2. Study start11 May 2017
  3. Primary completion28 Dec 2029 (estimated)
  4. Study completion28 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03153683
Sponsor's protocol ID
BACTRAC-17-0019-F1V
Acronym
BACTRAC
Status last verified
Mar 2026
First submitted
20 Apr 2017
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: To be announced.

Publications

  • 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.

    PubMed 39154085
  • 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.

    PubMed 37280551
  • 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.

    PubMed 36179808
  • 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.

    PubMed 35141572
  • 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.

    PubMed 34728392
  • 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.

    PubMed 34558059
  • 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.

    PubMed 34250820
  • 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.

    PubMed 33768217
  • 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.

    PubMed 32641418
  • 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.

    PubMed 32010048
  • 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.

    PubMed 30064997

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Ischemic Stroke and Cerebrovascular Disorders, run by Justin Fraser at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer R Isaacs, MS, MS (859-323-4738, jennifer.isaacs@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03153683, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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