Imaging plaque biology in patients with asymptomatic carotid artery stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate plaque biology in patients with asymptomatic carotid artery stenosis (ACAS) using advanced imaging techniques. Participants will undergo a carotid PET-MRI examination after receiving an intravenous injection of a radiotracer, 64Cu-CANF-Comb, to assess its uptake and correlate it with patient outcomes such as stroke or transient ischemic attack. The study will include 80 subjects and is designed to enhance understanding of the role of Natriuretic Peptide Receptor C in carotid atherosclerosis progression. The findings could help in risk stratification for stroke events in ACAS patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Washington University in St. Louis
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Pamela Woodard, MD — Washington University School of Medicine
• Study coordinator: Molly Mohrman
• Email: mohrmanm@wustl.edu
• Phone: 314-747-4633

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.