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NCT04632485 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by University of Wisconsin, Madison.

Completed
Registry status
217
Enrollment target

NCT04632485: Completed study, sponsored by University of Wisconsin, Madison.

NCT04632485 is a clinical trial that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 217 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04632485 has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
217 participants
Enrollment target

Study 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 potent

Primary Outcome

Participants will receive complete clinical carotid ultrasound examination. B-mode, Doppler and color-flow modes of Ultrasound will be captured. This measure will characterize artery wall stiffness and possible plaque by using Ultrasound.

Interventions

  • OTHER Neurocognitive testing
  • DEVICE Magnetic Resonance Imaging (MRI)
  • DEVICE Ultrasound imaging
  • DEVICE Transcranial Doppler (TCD)
  • DEVICE Pulse Wave Doppler

Trial Details

FieldValue
Enrollment Target 217 participants
Start Date 2021-09-09
Est. Completion 2025-06-30
University of Wisconsin, Madison

1,039 total trials

What the finished NCT04632485 record still lists

NCT04632485 is an observational study that tracks outcomes without assigning an intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 5 interventions - of which Neurocognitive testing is the first listed.

NCT04632485 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04632485 about?

NCT04632485 is a clinical study titled "Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging". 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) stra...

What is the current status of trial NCT04632485?

This trial is currently completed. The enrollment target is 217 participants. The study started on 2021-09-09. Estimated completion is 2025-06-30.

What interventions are being tested in trial NCT04632485?

The interventions under investigation include: Neurocognitive testing (OTHER), Magnetic Resonance Imaging (MRI) (DEVICE), Ultrasound imaging (DEVICE), Transcranial Doppler (TCD) (DEVICE), Pulse Wave Doppler (DEVICE).

Who is sponsoring clinical trial NCT04632485?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04632485, the US trial registry maintained by the National Library of Medicine. NCT04632485 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.