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



Status:Recruiting
Conditions:Cognitive Studies, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:5/5/2018
Start Date:February 17, 2017
End Date:December 31, 2019
Contact:Collin Arsenault
Email:Collin.Arsenault@hsc.utah.edu
Phone:801-585-1737

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Amyloid Deposition and Preexisting Vulnerable Carotid Plaque Features Predicting Cognitive Improvement After Surgery

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.

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.

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
We found this trial at
2
sites
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Joseph S McNally, MD, PhD
Phone: 801-585-1737
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Salt Lake City, Utah 84148
Principal Investigator: Joseph S McNally, MD, PhD
Phone: 801-585-1737
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Salt Lake City, UT
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