Transcranial Doppler(TCD) Evaluation of High Intensity Transient Signals and Carotid Disease

NCT05829200 | Withdrawn DMC

• 1 other identifier: TCD8675309
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Carotid Disease causes 10% of strokes. The Investigators are attempting to investigate the use of Transcranial Doppler to see if this is and effective, efficient, and/or valid way to identify individuals at highest risk for thromboembolic events from carotid disease. The plan is to plot the number of high intensity transient transcranial doppler signals with the category of patient (asymptomatic, symptomatic, and actively symptomatic) and evaluate if a relationship exists. The Investigators hypothesize that a linear relationship exists in that the higher the number of HITS the more symptomatic the patient. If results demonstrate the numbers of HITS correlate with the severity of disease this could potentially identify asymptomatic patients having subclinical symptoms who would benefit from a more urgent surgical intervention versus the current standard of care of elective intervention.

Conditions

Asymptomatic Carotid Stenosis; Symptomatic Carotid Stenosis; TCD; HITS

Keywords

TCD; HITS; Asymptomatic Carotid Stenosis; Symptomatic Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

• Number of HITS

  1 day

Study Arms (2)

Asymptomatic Carotid Disease

OTHER

All individuals who are consented for elective or urgent carotid endarterectomy would be eligible to participate. If patient gives consent, they would undergo an approximately 30-60 minute Transcranial Doppler (TCD)study. We will collect the number of high intensity transient signals (HITS). The patient would undergo surgery regardless of the TCD result.

Device: Transcranial Doppler (TCD)

Symtomatic Carotid Disease

OTHER

All individuals who are consented for elective or urgent carotid endarterectomy would be eligible to participate. If patient gives consent, they would undergo an approximately 30-60 minute Transcranial Doppler (TCD)study. We will collect the number of high intensity transient signals (HITS). The patient would undergo surgery regardless of the TCD result.

Device: Transcranial Doppler (TCD)

Interventions

Transcranial Doppler (TCD) DEVICE

All individuals who are consented for elective or urgent carotid endarterectomy would be eligible to participate. If patient gives consent, they would undergo an approximately 30-60 minute TCD study. We will collect the number of high intensity transient signals (HITS). The patient would undergo surgery regardless of the TCD result.

Asymptomatic Carotid Disease; Symtomatic Carotid Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any individual consented for elective or urgent carotid endarterectomy (asymptomatic stenosis \>80% and/or symptomatic carotid stenosis \>50%).

You may not qualify if:

• Any individual who is unstable and needs to go to the operating room emergently is excluded from this study.
• Any individual who can not tolerate a TCD exam will be excluded from this study

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Interventions

Ultrasonography, Doppler, Transcranial

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Hernan Bazan, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: April 25, 2023
• Study Start: July 15, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

US (1)