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

NCT ID: NCT03068442

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-17
• Study Completion Date: 2024-09-10

Brief Summary

The invesigators propose a clinical study on patients undergoing carotid surgery (endarterectomy). The invesigators will determine carotid artery imaging features associated with (1) vessel wall inflammation, (2) downstream brain inflammation, and (3) cognitive benefit from surgery. This project will uncover links between inflamed carotid plaque and downstream brain inflammation. The invesigators will also determine carotid plaque imaging features predicting cognitive benefit from carotid surgery.

Detailed Description

This research is directed at a major stroke source, the carotid artery, a major vessel that supplies blood to the brain. It has long been known that carotid narrowing is an important stroke risk factor. However, many patients with narrow carotids do not have strokes, and many patients with seemingly normal carotids have strokes. MRI research now suggests that the carotid wall itself is the stroke source. Using carotid MRI, clinicians can identify previously invisible markers of unstable carotid plaque, including carotid wall bleeds (intraplaque hemorrhage). The working hypothesis is that patients with these unstable carotid plaques may have higher inflammation in both their carotid arteries and brain. This inflammation has been implicated in other diseases, including dementia.

Carotid wall bleeds can easily be seen with carotid MRI, but are often invisible on ultrasound and CT scans. By using MRI, the invesigators have found that this silent killer is an important stroke risk factor even without carotid narrowing. Now that imaging can detect carotid wall bleeds, where do the bleeds come from? Recent research points to inflammation within the carotid wall. The invesigators plan to use histology to detect this inflammation in the vessel wall. Another question is, does inflammation in the carotid wall lead to inflammation in the brain? Using PET scans, the invesigators plan to determine whether inflammation in the brain is linked to carotid disease. Lastly, the invesigators hope to find out if carotid wall inflammation contributes to memory loss and if surgery is beneficial in these patients.

The invesigators hope to detect this inflammation in the vessel wall and brain before patients develop stroke, memory loss and dementia. This will be of huge benefit not only in the detection of diseases, but would also allow clinicians to monitor treatment effect on both carotid disease and brain inflammation. The invesigators also hope to use these tools to detect early treatment response. This research will accelerate the pace of future clinical trials to bring important new medications to patients sooner.

Conditions

Cognitive Impairment; Carotid Artery Plaque; Inflammation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Carotid atherosclerosis group

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

Group Type: EXPERIMENTAL

Imaging with flutemetamol F 18 PET/CT

Intervention Type: DRUG

All subjects will undergo diagnostic imaging as the intervention. This imaging will be with flutemetamol F 18 PET/CT

Interventions

Imaging with flutemetamol F 18 PET/CT

All subjects will undergo diagnostic imaging as the intervention. This imaging will be with flutemetamol F 18 PET/CT

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients with carotid occlusion will be excluded, due to one carotid contributing to both right and left brain blood supply.
• Other known sources of cardioembolism, including atrial fibrillation, mechanical heart valve, left atrial or ventricular thrombus or intracardiac mass, endocarditis, EF <30%
• Known stroke mimics including multiple sclerosis or brain tumor
• MRI contraindications per ACR guidelines, including patients with pacemakers, renal failure with eGFR<30 ml/min/1.73m2, and contrast allergy
• [18F]Flutemetamol contraindications per manufacturer guidelines, including patients with prior reactions
• Known stage IV malignancy
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Scott Mcnally

OTHER

Sponsor Role: lead

Responsible Party

Scott Mcnally

Assistant Professor, Department of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joseph S McNally, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

17SDG33460420

Identifier Type: -

Identifier Source: org_study_id