NCT04632485

Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 217 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is assess imaging and identification of soft plaque that undergoes large deformations or strain will identify plaque vulnerable to rupture which could lead to 'silent strokes'. Validation of current study results with MRI will foster use of real-time ultrasound (US) strain imaging and strain indices as a screening tool for identifying normal human participants susceptible to increased vascular aging and developing plaque prone to rupture or micro-embolization. Current research will evaluate Lagrangian carotid strain imaging (LCSI) for prediction of vascular health on volunteers. In this study, investigators will evaluate age-related strain variations (due to plaque deposition) in the carotid artery, establishing groundwork that will help identify typical and atypical values for these indices. Investigator's hypothesis is that plaques with higher strain indices (softer plaques) are more prone to rupture than plaques with lower strain indices (stiffer) plaques, thus requiring intervention. Clinical criteria for treatment has focused primarily on the degree of stenosis. Long-term objectives are to provide non-invasive methods for screening participants at risk for vascular aging or plaque rupture in asymptomatic participants, expanding upon current criteria for risk assessments based on focal transient ischemic attack (TIA) or strokes. Variations in vessel strain have been associated with, or are precursors to, plaque deposition, vascular aging, or cerebrovascular diseases. Increased arterial strain and pressure changes have been linked to brain aging using magnetic resonance imaging (MRI) based vascular indices, and memory deficits commonly linked to Alzheimer dementia. Stiffening and thickening of the arterial walls have also been associated with cerebrovascular disease. Investigators hypothesize that strain indices as vascular biomarkers can be utilized for screening possible 'vulnerable participants' validated with MRI, with the potential ability to improve endothelial function and reverse vascular aging. Strain indices may enable differentiating study participants with vascular cognitive impairment (VCI) from other dementias. Cognitive testing is unable to make this differentiation.

Conditions

• Healthy
• Carotid Artery Diseases

Interventions

Type	Name	Description
DEVICE	Ultrasound imaging	Carotid artery ultrasound exam. US imaging will include complete clinical carotid ultrasound examination (B-mode, Doppler and color-flow modes), clinical strain and shear wave imaging study, backscattered and beam-steered radiofrequency (RF) data acquisition using research mode, and reference phantom RF data acquisition.
DEVICE	Magnetic Resonance Imaging (MRI)	Head and Neck MRI exam with contrast
OTHER	Neurocognitive testing	Harmonization battery to assess executive function/attention, speeded psychomotor, verbal, and nonverbal memory, language, and visuospatial skills
DEVICE	Transcranial Doppler (TCD)	Use of a TCD system to monitor right and left middle cerebral artery Doppler waveforms in the volunteer for 60 minutes
DEVICE	Pulse Wave Doppler	Pulse wave Doppler will be used to acquire a Doppler waveform in the right common carotid artery and the right femoral artery

Timeline

• Start date: 2021-09-09
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2020-11-17
• Last updated: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study