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Carotid atherosclerosis group for Cognitive Impairment

Phase 2

Waitlist Available

Led By Joseph S McNally, MD, PhD

Research Sponsored by Scott Mcnally

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

• Patients ≥18 years old and plans for carotid endarterectomy.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 3 month followup

Awards & highlights

Study Summary

This trial will study whether there is a relationship between inflammation in the carotid artery and the brain, and whether this has an effect on cognition.

Who is the study for?

This trial is for adults over 18 who are scheduled to have carotid endarterectomy, a surgery on the arteries in their neck. It's not specified who can't join, but typically people with conditions that could interfere with the study or its results might be excluded.Check my eligibility

What is being tested?

The study is testing if imaging of the carotid artery using flutemetamol F 18 PET/CT scans can predict inflammation in the artery wall, brain inflammation, and cognitive improvements after surgery.See study design

What are the potential side effects?

While this trial focuses on imaging rather than medication, side effects may include reactions to contrast agents used during PET/CT scans such as mild allergic reactions or discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 3 month followup

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 3 month followup

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 3 month followup for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Carotid MRI-detected intraplaque hemorrhage and prediction of brain inflammation on PET/CT.

Carotid intraplaque hemorrhage correlation with carotid plaque inflammation on immunohistochemistry.

Preoperative MRI-detected carotid intraplaque hemorrhage and prediction of cognitive improvement after endarterectomy.

Side effects data

From 2011 Phase 3 trial • 218 Patients • NCT01265394

General Disorders and Administration Site Conditions

Vascular System Disorders

Vascular System Disorders-Flushing

Gastrointestinal disorders

100%

80%

60%

40%

20%

Study treatment Arm

(18F) Flutemetamol

Trial Design

1Treatment groups

Experimental Treatment

Group I: Carotid atherosclerosis groupExperimental Treatment1 Intervention

This group includes all enrolled subjects (those with carotid disease and plans to undergo surgery).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Scott McnallyLead Sponsor

American Heart AssociationOTHER

326 Previous Clinical Trials

4,933,832 Total Patients Enrolled

Joseph S McNally, MD, PhDPrincipal InvestigatorUniversity of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being recruited for this ongoing study?

"As per the information available on clinicaltrials.gov, this particular study is not currently seeking participants. It was initially posted on February 17th, 2017 and most recently updated on January 9th, 2024. However, it is worth noting that there are presently 521 other studies actively recruiting individuals at this time."

Answered by AI

Has the Carotid Atherosclerosis Group received official approval from the FDA?

"Based on our evaluation, the safety of the Carotid atherosclerosis group is scored at 2. This rating reflects that while there is some available data supporting its safety, no evidence has been obtained yet to support its efficacy in this Phase 2 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Role of Large Artery Plaque Imaging Features in Predicting Inflammation and Cognition

Scott Mcnally 2017. "The Role of Large Artery Plaque Imaging Features in Predicting Inflammation and Cognition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03068442.

All > Utah