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NCT05838547 · ClinicalTrials.gov registry record

CANF-Comb-II PET-MR in Atherosclerosis Multisite

A clinical trial of Carotid Atherosclerosis and Asymptomatic Carotid Artery Stenosis, sponsored by Washington University School of Medicine.

Recruiting
Registry status
80
Enrollment target
2
Study locations

NCT05838547: Recruiting study of Carotid Atherosclerosis and Asymptomatic Carotid Artery Stenosis, sponsored by Washington University School of Medicine.

NCT05838547 is a study of Carotid Atherosclerosis and Asymptomatic Carotid Artery Stenosis that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 80 participants, below the 157-participant average among 5 other Carotid Atherosclerosis trials with a reported enrollment target (49% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05838547, a study of Carotid Atherosclerosis and Asymptomatic Carotid Artery Stenosis, is actively recruiting participants, sponsored by Washington University School of Medicine.

RECRUITING
Registry status
80 participants
Enrollment target
2
Study locations

Study 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).

Primary Outcome

Patients will be contacted every 3 months after PET/MR imaging to assess for interval ipsilateral ischemic cerebrovascular event. In patients treated with OMT, it is anticipated that higher 64Cu-CANF-Comb PET signal (SUV) will correlate with increased ipsilateral ischemic cerebrovascular event (TIA, stroke) or remote ipsilateral carotid intervention (CEA surgery or stent placement); PET signal (SUV) will be assessed as a marker of risk for event in comparison to anatomic features of vulnerable p

Conditions Studied

Carotid Atherosclerosis Asymptomatic Carotid Artery Stenosis Carotid Artery Atheroma

Interventions

  • DRUG 64Cu-25%-CANF-Comb

Study Locations (2)

California

  • Cedars Sinai Medical Center - Los Angeles

Missouri

  • Washington University in St. Louis - St Louis

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2023-03-21
Est. Completion 2027-05-31
Washington University School of Medicine

1,502 total trials

What NCT05838547 shows while recruiting

NCT05838547 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 157-participant average among 5 other Carotid Atherosclerosis trials with a reported enrollment target (49% lower).

The record links to 3 conditions, with Carotid Atherosclerosis appearing as the primary indexed condition, and to 1 intervention - of which 64Cu-25%-CANF-Comb is the first listed.

NCT05838547 reports a single indexed study location in California, Missouri.

Frequently Asked Questions

What is clinical trial NCT05838547 about?

NCT05838547 is a clinical study titled "CANF-Comb-II PET-MR in Atherosclerosis Multisite". 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 patient...

What is the current status of trial NCT05838547?

This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2023-03-21. Estimated completion is 2027-05-31.

What conditions does trial NCT05838547 study?

This clinical trial studies the following conditions: Carotid Atherosclerosis, Asymptomatic Carotid Artery Stenosis, Carotid Artery Atheroma.

What interventions are being tested in trial NCT05838547?

The interventions under investigation include: 64Cu-25%-CANF-Comb (DRUG).

Who is sponsoring clinical trial NCT05838547?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05838547 being conducted?

This trial has 2 study locations across California, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT05838547

Source: ClinicalTrials.gov NCT05838547, the US trial registry maintained by the National Library of Medicine. NCT05838547 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.