Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05518305

Conditions

Stroke

TIA

Ischemic Stroke

Ischemic

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

Interventions

Medical Imaging

Study Details

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

Study ID

NCT05518305

Start date

Sep 30, 2022

Status verified date

Jun, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

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 TIA, 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 informed consent for participation in the study.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Medical Imaging

magnetic resonance imaging

Primary outcome measure

  • Determine the impact of platelet FcγRIIa expression on 1-year risk of recurrent stroke in ICAD. [ Time Frame: 1 year ]
  • Quantify the impact of WSS from CTA CFD on 1-year risk of recurrent stroke in ICAD [ Time Frame: 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. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

David Liebeskind, MD

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

Locations

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Ryan Apfel

rapfel@mednet.ucla.edu

Principal Investigator:

David Liebeskind, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-06-11.