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

NCT05518305 | Recruiting

• 1 other identifier: NS123734
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; TIA; Ischemic Stroke; Ischemic

Keywords

Stroke

Outcome Measures

Primary Outcomes (3)

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

Study Arms (1)

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

Medical Imaging DIAGNOSTIC_TEST

magnetic resonance imaging

All

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with who have experience a Stroke or TIA

You may qualify if:

• 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.
• 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 informed consent for participation in the study.

You may not qualify if:

• Other determined etiology or established cause of the acute stroke or TIA: atrial fibrillation, mitral stenosis, mechanical valve, intracardiac thrombus or vegetation, dilated cardiomyopathy or ejection fraction \<30%, proximal extracranial carotid or vertebral stenosis \>50%.
• Contraindications 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Pittsburgh Medical Center: collaborator
• University of Chicago: collaborator
• Bay State Clinical Trials, Inc.: collaborator
• Yale University: collaborator
• University of Vermont: collaborator

Study Sites (1)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Ischemia

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

David Liebeskind, MD

CONTACT

‭(310) 963-5539‬; dliebeskind@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology Professor

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: September 30, 2022
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)