A Novel Method for Determination of Thromboembolic Stroke Origin

Part of paid clinical trials in Summit, New Jersey.

Sponsor
Atlantic Health System
Study ID
NCT06961604
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Thromboembolic Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NaF PET-CT — DRUG
    Following a non-cardiogenic thromboembolic stroke, patients will undergo NaF PET-CT imaging to identify the culprit plaque and any other vulnerable plaques at high risk for rupture

Study Details

Rupture of vulnerable carotid, vertebral, and intracranial arterial plaques results in thromboembolic stroke. Identification of these culprit lesions is an important component of post-stroke care. This study seeks to test the feasibility of NaF PET-CT to detect these plaques and alter patient care. Prior studies have shown a high degree of correlation between NaF PET+ lesions and high-risk plaque features on high resolution MRI, including mirocalcification, necrosis, and ulceration.

Key Dates

Start date
Jun 1, 2025
Status verified
May 2025
Primary completion
Jun 1, 2025
Completion
May 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Intervention - NaF PET
    Intervention/Experimental Arm - non-cardiogenic thromboembolic stroke patients to undergo NaF PET-CT

Primary Outcome Measure

Culprit lesion [ Time Frame: Within 14 days of the stroke ]

Locations (1)

FacilityCityStateZIPSite coordinators
Overlook Medical CenterSummitNew Jersey07901
James Cassuto, MD, PhD
908-522-2337
James Cassuto, MD, PhD (PRINCIPAL_INVESTIGATOR)

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