Clinical Study of Vascular Plaque Determination for Stroke Risk Assessment
Abstract
Objective and Rationale: Patients with diabetes have a greater chance of plaque buildup in their arteries. Plaque buildup in the carotid artery can lead to increased risk of stroke from blood clots forming on the plaque and breaking off, or parts of the plaque itself breaking off and lodging in the brain, causing a stroke or even death. Current clinical care is able to measure the size of the plaque, which is related to the risk of stroke; however, many patients with relatively small plaques have strokes arising from the carotid plaque, as well. Thus, more information regarding the plaque is needed. This project proposes to use ultrasound non-invasively (without entering the body) to provide additional information on not just the size of the plaque but also on the composition. Some plaque can be resilient and stable, whereas other carotid plaque can be quite soft and unstable. We propose testing a new algorithm developed under a previous Peer Reviewed Medical Research Program Investigator-Initiated Research Award grant, which is called the Compositional Analysis System by Machine learning (CASM) algorithm. This algorithm will be applied to the same ultrasound signals used for regular imaging to see if the composition information is linked with future risk of stroke, and to see if it can be used to follow patients who are receiving drugs or other therapy. Topic Area: The proposed research falls within the Diabetes topic area. Specifically, the research aims to improve the treatment of complications of diabetes mellitus through improved understanding of the risks that diabetic patients have for a future stroke. Diabetic patients are at higher risk of a buildup of plaque within their carotid arteries, and have riskier plaques for the same amount of blockage as compared to people without diabetes. Diabetic patients are also at a greater risk for the plaque getting worse and of complications from surgery. Thus, more information about the plaque is useful for all patients and more so for patients with diabetes. Impact of the Research: This research will enroll 1,500 patients and follow them for up to 3 years from two sites: Cleveland Clinic and Louis Stokes Cleveland Veterans Affairs Medical Center. Each patient will have ultrasound data collected and used to look at the plaque in three dimensions using the CASM algorithm (created during the earlier research award). The patients who will be studied are over the age of 40 and have greater than 40% blockage in their carotid artery (surgery is generally recommend for twice this amount of blockage). This is the same group of patients who would be helped with successful completion of this research. The goal of the research is an application for approval by the U.S. Food and Drug Administration (FDA). This application would be based on the results of the proposed clinical study. Successfully completing this research would provide information about carotid artery blockage that is not currently available, except in a few cases with the use of magnetic resonance imaging (MRI). However, the cost and limited availability of MRI keep it from being used in all cases. Thus, the non-invasive ultrasound proposed in this research would be an inexpensive way to provide this information for all patients with carotid stenosis. Since the ultrasound causes no harm to the patients, the CASM algorithm could be used to catch patients who have small but dangerous plaque, and could also be used to see if drug treatment is changing the makeup of the plaque.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010615
Entities
People
- David Geoffrey Vince
Organizations
- Cleveland Clinic
- United States Army