NCT05838547 CANF-Comb-II PET-MR in Atherosclerosis Multisite
| NCT ID | NCT05838547 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Carotid Atherosclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-03-21 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-03-21 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to learn more about plaque biology in asymptomatic carotid artery stenosis (ACAS) patients through imaging. The main questions it aims to answer are: * To determine the ability of 64Cu-CANF-Comb positron emission tomography (PET) to risk stratify ACAS patients for stroke event, to include transient ischemic attack or remote ipsilateral intervention. * To further understand the role of Natriuretic Peptide Receptor C (NPRC) in the evolution of carotid atherosclerosis. Participants will be asked to undergo a carotid PET-magnetic resonance imaging (MRI) examination to assess whether the carotid atherosclerosis uptake of 64Cu-CANF-Comb as measured by PET-MRI correlates with patient outcomes (stroke, transient ischemic attack, or remote ipsilateral intervention).
Eligibility Criteria
Inclusion Criteria: * Adults, 18 years of age or older * Asymptomatic carotid artery stenosis patients who have undergone carotid Doppler/ultrasound imaging or other carotid imaging which have demonstrated a ≥ 60% diameter carotid artery stenosis. * The treating surgeon has planned either treatment with optimal medical therapy (OMT) alone, or OMT and carotid endarterectomy (CEA) surgical intervention. Exclusion Criteria: * Inability to receive and sign informed consent. * Patients with an unstable clinical condition that in the opinion of the Sponsor-Investigator or designee precludes participation in the study. * Inability to tolerate up to 60 minutes in a supine position with arms down at sides for PET-MR imaging. * Prior history of CEA or carotid artery stent procedure on the ipsilateral side. * Past medical history of TIA or stroke within the last 6 months. * Unwilling to comply with study procedures and/or unable to be available for the duration of the study outlined in the protocol. * Contraindications to MR imaging (pacemaker, brain aneurysm clips, shrapnel, claustrophobia, etc.). * Currently pregnant or lactating. All female subjects of childbearing potential must have a documented negative pregnancy test (serum or urine hCG) performed within 24 hours immediately prior to the administration of 64Cu-25%-CANF-Comb or documented post-menopausal defined as the cessation of menses for ≥ 12 months or documentation of having a bilateral oophorectomy and/or hysterectomy.
Contact & Investigator
Pamela Woodard, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT05838547 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carotid Atherosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05838547 currently recruiting?
Yes, NCT05838547 is actively recruiting participants. Contact the research team at mohrmanm@wustl.edu for enrollment information.
Where is the NCT05838547 trial being conducted?
This trial is being conducted at Los Angeles, United States, St Louis, United States.
Who is sponsoring the NCT05838547 clinical trial?
NCT05838547 is sponsored by Washington University School of Medicine. The principal investigator is Pamela Woodard, MD at Washington University School of Medicine. The trial plans to enroll 80 participants.