ClinicalTrials.gg
RecruitingNCT05518305FCGUpdated Jun 11, 2026

Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis

An observational study in Stroke, TIA and Ischemic Stroke, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.

Primary conditionIschemic StrokeRegistry: StrokeReclassifiedWhy we changed it
Registry
Stroke — the first condition term the registry derived for this study.
ClinicalTrials.gg
Ischemic Stroke
Why
  1. The study's listed conditions name Ischemic Stroke, a narrower term within Stroke.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of California, Los Angeles · Observational

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
30 Years and older
Sex
All
01

Study summary

An observational study to determine if individuals with increased platelet FcyRIIa will have a higher risk of ischemic events.

Read the detailed description

Recurrent ischemic stroke due to intracranial atherosclerotic disease (ICAD) is extremely common despite treatment with anti-platelet medications. Heterogeneity of the arterial architecture and associated blood flow changes in ICAD-related stenoses result in different patterns of wall shear stress (WSS) from one individual to the next. Such wall shear stress can be readily quantified with computational fluid dynamics (CFD) from noninvasive CT angiography (CTA), routinely acquired in patients with minor stroke or transient ischemic attack (TIA) due to ICAD. These shear stress changes in blood flow promote platelet aggregation and thereby alter the response to anti-platelet therapy. Additionally, greater platelet FcγRIIa expression increases platelet reactivity and promotes thrombosis when platelets are exposed to increased shear stress. In the coronary circulation, greater platelet expression of FcγRIIa identifies patients at greater risk of recurrent cardiovascular events, including stroke. Numerous mechanisms have been invoked in the recurrence of ischemia in ICAD, yet focused research on the pathophysiology of shear stress and platelet activation has not been evaluated to explain the high rate of imaging evidence and clinical strokes following minor stroke or TIA due to ICAD. Given the shared pathology of coronary artery disease and ICAD, the data suggest that individual differences in CFD-derived WSS and platelet FcγRIIa expression may inform a precision medicine strategy to prevent recurrent stroke. The investigators developed a novel approach to validate CTA CFD values of WSS in stenoses in ICAD with precision 3D cerebrovascular models, including data from the landmark SAMMPRIS trial. In other collaborations, The investigators have separately studied the potential impact of elevated WSS on stroke recurrence in ICAD and conducted an observational multicenter study on mechanisms of recurrent stroke in ICAD. The investigators and others have demonstrated that greater platelet FcγRIIa expression increases the activation of platelets in response to agonists and shear stress. These synergies now enable us to investigate how the interaction of anti-platelet therapies with individual platelet expression of FcγRIIa and WSS calculated from patient-specific CTA CFD may explain recurrent ischemia after minor stroke or TIA due to ICAD. The investigators hypothesize that the incidence of recurrent silent ischemia on MRI and clinical strokes by 1 year after minor stroke or TIA due to ICAD will be predicted by quantifying individual risk determined by platelet FcγRIIa expression and focal elevations in WSS due to stenosis.

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Conditions studied

  • Stroke
  • TIA
  • Ischemic Stroke
  • Ischemic

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Keywords

  • Stroke
03

In context

Ischemic Stroke Reclassified

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 250 is below the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.

Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Individuals with who have experience a Stroke or TIA

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Stroke is defined as symptoms lasting >24 hours and associated with imaging evidence of acute ischemia in the distribution of the stenotic vessel on head CT or brain MRI. Minor stroke is defined as NIHSS\<6, as used in prior studies.
  • Eligible , defined as transient neurological symptoms lasting \<24 hours, need to be: a) accompanied by DWI abnormalities in the distribution of the stenotic artery; or b) multiple (>1), stereotyped events associated with unequivocal ischemic symptoms (i.e. weakness, aphasia, diplopia), and attributed to the symptomatic artery. The intent of these restrictive inclusion criteria for TIA is to exclude potential stroke mimics.
  • ICAD should involve the intracranial carotid, middle cerebral, intracranial vertebral or basilar arteries. Isolated anterior and posterior cerebral artery stenosis is not included as it is uncommon in these locations and non-invasive criteria for high-grade ICAD are not well established for these vessels.
  • Stenosis 50-99% will be quantified by CTA. The criteria for 50-99% are: measured stenosis by WASID criteria (percent stenosis = (1-[diameter stenosis/diameter normal]) x 100%.
  • Age ³30; those 30-49 years of age must also have the presence of established atherosclerotic disease in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years). The rationale for this criterion is to exclude non-atherosclerotic vasculopathies.
  • Provide for participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Other determined etiology or established cause of the acute stroke or : atrial fibrillation, mitral stenosis, mechanical valve, intracardiac thrombus or vegetation, dilated cardiomyopathy or \<30%, proximal extracranial carotid or vertebral stenosis >50%.
  • to MRI, including MR-incompatible metallic implants (i.e. certain artificial cardiac valves, penile implants, other prosthesis), implanted electronic devices (i.e. pacemaker/defibrillator, neurostimulators, cochlear implants), other potentially mobile ferromagnetic material (i.e. shrapnel, magnetic aneurysm clips), pregnancy (women in fertile age should have a negative pregnancy test), lactation, morbid obesity, and severe claustrophobia.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • All

    Blood sampling and an MRI will be conducted alongside standard stroke cognitive tests upon enrollment. A follow-up three-month visit will check for adverse events and a follow-up cognitive stroke test. At 12 months, an MRI will be conducted alongside a cognitive test.

    Diagnostic Test: Medical Imaging

Interventions

  • Diagnostic testMedical Imaging

    magnetic resonance imaging

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What researchers measure

Primary outcomes

  1. Determine the impact of platelet FcγRIIa expression on 1-year risk of recurrent stroke in ICAD.

    The investigators hypothesize that increased platelet FcγRIIa will be associated with a greater risk of ischemic events. Platelet FcγRIIa expression will be quantified in 250 subjects enrolled at 6 sites with stroke or TIA due to 50-99% ICAD to determine impact of FcγRIIa on 1-year risk of recurrent stroke, including clinical events and serial MRI.

    Time frame: 1 year

  2. Quantify the impact of WSS from CTA CFD on 1-year risk of recurrent stroke in ICAD

    The investigators hypothesize that high WSS and an elevated post-stenotic oscillatory shear index (OSI) that are stimuli of shear-induced platelet aggregation will confer an increased risk of recurrent ischemic stroke. We will use routinely acquired CTA in 250 subjects enrolled at 6 sites with stroke or TIA due to 50-99% ICAD to quantify the impact of WSS and post-stenotic OSI on 1-year risk of recurrent stroke, including clinical events and serial MRI.

    Time frame: 1 year

  3. Develop a precision model to determine the risk of recurrent stroke 1 year after index events due to ICAD based on individual FcγRIIa expression and WSS from baseline CTA.

    The investigators hypothesize that the 1-year recurrent stroke risk associated with high platelet FcγRIIa expression and high WSS will be more than additive.

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05518305
Collaborators
University of Pittsburgh Medical Center, University of Chicago, Bay State Clinical Trials, Inc., Yale University, University of Vermont, University of Southern California
Responsible party
David Liebeskind (Neurology Professor, University of California, Los Angeles) — Principal investigator
First posted
Aug 26, 2022
Start date
Sep 30, 2022
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Jun 11, 2026

Study contacts

David Liebeskind, MD
Contact
dliebeskind@mednet.ucla.edu
‭(310) 963-5539‬

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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