Asymptomatic Carotid StenosisTCDNCT05829200
Transcranial Doppler(TCD) Evaluation of High Intensity Transient Signals and Carotid Disease
A study testing Transcranial Doppler (TCD) in people with Asymptomatic Carotid Stenosis and Symptomatic Carotid Stenosis, run by Ochsner Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Carotid Stenosis, Symptomatic Carotid Stenosis, TCD
- What is being tested?
- Transcranial Doppler (TCD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any individual consented for elective or urgent carotid endarterectomy (asymptomatic stenosis >80% and/or symptomatic carotid stenosis >50%).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Medical Center
New Orleans, Louisiana, 70121
About this study
Official title: Transcranial Doppler(TCD) Evaluation of High Intensity Transient Signals (HITS) in Asymptomatic and Acutely Symptomatic Patients With Carotid Occlusive Disease
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.
Read the detailed description
Approximately 20% of strokes are attributable to carotid stenosis through atheroembolic events. Ischemic stroke confers a significant morbidity and mortality. Operative intervention (carotid endarterectomy [CEA]) has proven to decrease the risk of ischemic stroke. The guidelines for patient selection for carotid surgical intervention were established in the 1990s and have proven reasonably adequate, however with improving technology there may be modalities that can identify patients that may be at a higher risk than initially thought. One such modality that is under investigation is the use of transcranial doppler (TCD).
Presently, TCD is primarily used in conjunction with neuro-interventionalist related procedures (cerebral angiogram/stenting/coiling) to monitor for vasospasm and blood flow within the cerebral circulation. The technology assessment report of the American Academy of Neurology published in 1990 stated that TCD has established value in the assessment of patients with intracranial stenosis, collaterals, subarachnoid hemorrhage, and brain death. TCD has been used during intraoperative carotid endarterectomy to evaluate blood flow and need for arterial shunting. Recently, it has been used to identify and detect microemboli via the evaluation of high intensity transient signals (HITS). It has been shown in asymptomatic carotid patients that aggressive medical management can decrease the number of HITS on TCD potentially conferring a decrease in stroke. There is more literature evolving that demonstrates the potential of TCD being used to assist in patient selection for surgical intervention (carotid endarterectomy); however the studies have not yet been conducted. Our study is the first step in beginning this process.
The current standard of care is to consider surgical intervention for the following three groups of patients with carotid stenosis (a narrowing of the internal carotid artery): asymptomatic patients are defined as patients who have not experienced a transient ischemic attack (TIA) and/or stroke-like symptoms who have been identified as having a high grade carotid stenosis (narrowing of the internal carotid artery of greater than 80% via CTA, Carotid Doppler Ultrasound, and/or MRA); symptomatic patients who have previously experienced a ischemic stroke or TIA (no active symptoms at the time of presentation) and have 50% or greater carotid stenosis diagnosed by the same imaging modalities; the third group are individuals who present to the hospital as their ischemic symptoms have recently or are actively occurring with 50% or greater stenosis, unfavorable plaque, and/or acute carotid occlusion (diagnosed by the same imaging modalities). Our study proposes that the aforementioned patients undergo TCD to evaluate the number of HITS prior to surgical intervention.
TCD is a non-invasive study. It does not involve injection of any contrast material or the need for blood work prior to its undertaking. The test itself takes 30-60 minutes. The test would be administered by one specifically trained ultrasound technician. The TCD information will not affect patient care in any way; no definitive treatment will be delayed. The number of HITS would not change the type or timing of surgical intervention.
This is a prospective study. The first two groups of patients are generally referred to Ochsner's vascular surgeons and if eligible for surgical intervention during a clinic visit would be electively referred to get the non-invasive TCD test. There are some individuals in the second group who may have been admitted to the hospital and their symptoms have resolved. This group would be identified by neurology and radiology members of the stroke team via consult to the vascular surgery service. The TCD could be done while the patient was hospitalized. The third group is identified during a stroke code process. If the patient is found to meet surgical criteria the patient would undergo TCD in the emergency department or on the floors upon admission. The TCD order would be initiated by the stroke code team or vascular surgery.
The TCD reports would be forwarded to and kept by the study coordinator.
The plan would then be to plot the number of HITS 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
- Being tested
- Transcranial Doppler (TCD)
- Keywords
- TCD, HITS, Asymptomatic Carotid Stenosis, Symptomatic Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcranial Doppler (TCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HITS
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 Jul 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hernan Bazan, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829200
- Sponsor's protocol ID
- TCD8675309
- Acronym
- TCD
- Status last verified
- Apr 2023
- First submitted
- 8 Jul 2013
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Doppler(TCD) Evaluation of High Intensity Transient Signals (HITS) in Asymptomatic and Acutely Symptomatic Patients With Carotid Occlusive Disease
- ClinicalTrials.gov ID
- NCT05829200
- Acronym / sponsor ID
- TCD / TCD8675309
- Conditions
- Asymptomatic Carotid Stenosis, Symptomatic Carotid Stenosis, TCD, HITS
- Keywords
- TCD, HITS, Asymptomatic Carotid Stenosis, Symptomatic Carotid Stenosis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 15 Jul 2013 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 20% of strokes are attributable to carotid stenosis through atheroembolic events. Ischemic stroke confers a significant morbidity and mortality. Operative intervention (carotid endarterectomy [CEA]) has proven to decrease the risk of ischemic stroke. The guidelines for patient selection for carotid surgical intervention were established in the 1990s and have proven reasonably adequate, however with improving technology there may be modalities that can identify patients that may be at a higher risk than initially thought. One such modality that is under investigation is the use of transcranial doppler (TCD).
Presently, TCD is primarily used in conjunction with neuro-interventionalist related procedures (cerebral angiogram/stenting/coiling) to monitor for vasospasm and blood flow within the cerebral circulation. The technology assessment report of the American Academy of Neurology published in 1990 stated that TCD has established value in the assessment of patients with intracranial stenosis, collaterals, subarachnoid hemorrhage, and brain death. TCD has been used during intraoperative carotid endarterectomy to evaluate blood flow and need for arterial shunting. Recently, it has been used to identify and detect microemboli via the evaluation of high intensity transient signals (HITS). It has been shown in asymptomatic carotid patients that aggressive medical management can decrease the number of HITS on TCD potentially conferring a decrease in stroke. There is more literature evolving that demonstrates the potential of TCD being used to assist in patient selection for surgical intervention (carotid endarterectomy); however the studies have not yet been conducted. Our study is the first step in beginning this process.
The current standard of care is to consider surgical intervention for the following three groups of patients with carotid stenosis (a narrowing of the internal carotid artery): asymptomatic patients are defined as patients who have not experienced a transient ischemic attack (TIA) and/or stroke-like symptoms who have been identified as having a high grade carotid stenosis (narrowing of the internal carotid artery of greater than 80% via CTA, Carotid Doppler Ultrasound, and/or MRA); symptomatic patients who have previously experienced a ischemic stroke or TIA (no active symptoms at the time of presentation) and have 50% or greater carotid stenosis diagnosed by the same imaging modalities; the third group are individuals who present to the hospital as their ischemic symptoms have recently or are actively occurring with 50% or greater stenosis, unfavorable plaque, and/or acute carotid occlusion (diagnosed by the same imaging modalities). Our study proposes that the aforementioned patients undergo TCD to evaluate the number of HITS prior to surgical intervention.
TCD is a non-invasive study. It does not involve injection of any contrast material or the need for blood work prior to its undertaking. The test itself takes 30-60 minutes. The test would be administered by one specifically trained ultrasound technician. The TCD information will not affect patient care in any way; no definitive treatment will be delayed. The number of HITS would not change the type or timing of surgical intervention.
This is a prospective study. The first two groups of patients are generally referred to Ochsner's vascular surgeons and if eligible for surgical intervention during a clinic visit would be electively referred to get the non-invasive TCD test. There are some individuals in the second group who may have been admitted to the hospital and their symptoms have resolved. This group would be identified by neurology and radiology members of the stroke team via consult to the vascular surgery service. The TCD could be done while the patient was hospitalized. The third group is identified during a stroke code process. If the patient is found to meet surgical criteria the patient would undergo TCD in the emergency department or on the floors upon admission. The TCD order would be initiated by the stroke code team or vascular surgery.
The TCD reports would be forwarded to and kept by the study coordinator.
The plan would then be to plot the number of HITS 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Carotid Disease | Other | Device: Transcranial Doppler (TCD)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. |
| Symtomatic Carotid Disease | Other | Device: Transcranial Doppler (TCD)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any individual consented for elective or urgent carotid endarterectomy (asymptomatic stenosis >80% and/or symptomatic carotid stenosis >50%).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Doppler (TCD)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. | Device | Asymptomatic Carotid Disease, Symtomatic Carotid Disease |
Primary outcome
Number of HITS
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hernan Bazan, MD principal investigator
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Doppler (TCD) in people with Asymptomatic Carotid Stenosis and Symptomatic Carotid Stenosis, run by Ochsner Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of HITS (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.