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New treatment option for Asymptomatic Carotid Stenosis (50-69%)
Official title Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention
ClinicalTrials.gov ID: NCT05436600
What this study is testing
- What it's testing
- Moderate (50-69%) asymptomatic carotid artery stenosis (ACAS) is an important and under-appreciated contributor to balance and mobility dysfunction. This is significant because declines in balance and mobility are a significant predictor of falls, disability, loss of independence, and death in older adults.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89. Healthy volunteers may be eligible.
You may be able to join if
- Eligible patients will be at least 18 years of age and will have asymptomatic 50-69% carotid stenosis
- Asymptomatic status will be confirmed as in NIH trials on asymptomatic carotid stenosis, by medical history, physical examination, and the National...
- Stenosis severity will be determined by duplex sonography, MR angiography, or CT angiography
You likely can't join if
- previous stroke or transient ischemic attack
- occlusion or severe stenosis of the non-index carotid artery
- planned carotid revascularization
- persons advised by their doctor not to exercise
- a medical condition that precludes the ability to ambulate
- exercise or reduces the likelihood of follow-up
See the full eligibility criteria
- Eligible patients will be at least 18 years of age and will have asymptomatic 50-69% carotid stenosis
- Asymptomatic status will be confirmed as in NIH trials on asymptomatic carotid stenosis, by medical history, physical examination, and the National Institutes of Health Stroke Scale (NIHSS)
- Stenosis severity will be determined by duplex sonography, MR angiography, or CT angiography
- previous stroke or transient ischemic attack
- occlusion or severe stenosis of the non-index carotid artery
- planned carotid revascularization
- persons advised by their doctor not to exercise
- a medical condition that precludes the ability to ambulate
- exercise or reduces the likelihood of follow-up
- evidence of a medical condition that would lead to an increased risk of accident, injury, or illness as a result of the proposed testing or intervention
- orthostatic hypotension
- severe medical illness that interferes with the evaluation of outcomes
- uncorrected visual impairment or eye surgery in the past 6 months
- patients that are unable to undergo PW-MRI due to gadolinium contrast allergy or renal insufficiency will also be excluded
- given the possibility that comorbid cognitive impairment may influence balance and mobility function, people with any documented medical history of dementia or cognitive impairment or those unable to follow commands...
- In addition, people with other neurological conditions such as Parkinson's, peripheral neuropathy or myopathy, sedative medications, and major depression (Center for Epidemiological Studies Depression Survey Score \>16)...
- in order to avoid ceiling effects of the Mini BESTest, potential people will be prescreened for balance dysfunction using a 10-second Single Leg Stance Test
- those that are able to complete the test without losing balance on either side will be excluded from the study
- the investigators will exclude people that participate in structured aerobic exercise routinely greater than three times per week within a month of starting the study
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.