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

NCT03068442 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 17SDG33460420
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Cognitive Impairment; Carotid Artery Plaque; Inflammation

Keywords

Carotid artery; MRI; PET; Intraplaque hemorrhage

Outcome Measures

Primary Outcomes (3)

• Carotid intraplaque hemorrhage correlation with carotid plaque inflammation on immunohistochemistry.

  Carotid plaque inflammation will be calculated with quantitative immunohistochemistry and correlated with intraplaque hemorrhage while controlling for confounders.

  baseline

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

  Outcome 2. The primary outcome, brain inflammation will be compared in carotid intraplaque hemorrhage positive and negative sides, controlling for confounders including stenosis and perfusion.

  baseline

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

  Outcome 3. The primary outcome, difference in cognitive score will be compared in carotid intraplaque hemorrhage positive and negative patients, controlling for stenosis, perfusion and ischemic symptoms.

  Change from baseline at 3 month followup

Study Arms (1)

Carotid atherosclerosis group

EXPERIMENTAL

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

Drug: Imaging with flutemetamol F 18 PET/CT

Interventions

Imaging with flutemetamol F 18 PET/CT DRUG

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

Carotid atherosclerosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scott Mcnally: lead
• American Heart Association: collaborator

Study Sites (2)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Carotid Stenosis; Inflammation

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Joseph S McNally, MD, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Radiology

Model Details: This is a diagnostic-interventional cohort study in patients undergoing carotid endarterectomy for atherosclerotic disease.

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 1, 2017
• Study Start: February 17, 2017
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)