Actively Recruiting
Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis
Led by Yi Yang · Updated on 2024-03-01
850
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
Sponsors
Y
Yi Yang
Lead Sponsor
S
Shenzhen Second People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with symptomatic cerebral atherosclerotic stenosis (sCAS), a condition linked to 33-50% of ischemic strokes in China and a high risk of stroke recurrence. The study aims to explore how cerebral autoregulation (CA), the brain's ability to maintain stable blood flow despite blood pressure changes, relates to stroke recurrence and to identify CA parameter thresholds that may predict recurrence. This is a multi-center prospective observational study enrolling 850 patients. The study involves measuring cerebral autoregulation using transcranial Doppler combined with a servo-controlled plethysmograph at two time points: within 0-3 days and 10-30 days after an ischemic cerebrovascular event such as a stroke or transient ischemic attack. Clinical data, brain imaging, biochemical tests, and follow-up information will be collected and recorded. No experimental drug or treatment is given, as this is an observational study focused on assessing CA and its relationship to stroke outcomes. Participants will undergo assessments at specified intervals, including cerebral autoregulation measurements shortly after their stroke or transient ischemic attack. Researchers will collect clinical and imaging data and follow participants for up to two years to track stroke recurrence and related outcomes. Primary outcomes include stroke recurrence rates over two years, while secondary measures include cerebral autoregulation indices, functional scores like the modified Rankin Scale (mRS) and Barthel score, and neurological status assessed by the NIH Stroke Scale (NIHSS).
CONDITIONS
Brief Title
Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Unilateral internal carotid artery or M1 segment of middle cerebral artery stenosis with 50-99% narrowing
- Acute ischemic cerebrovascular event (TIA or ischemic stroke) within the area supplied by the stenotic artery
- Stroke or TIA onset less than 30 days before enrollment
- Modified Rankin Scale score of 1 or less before stroke onset
- National Institutes of Health Stroke Scale score of 20 or less
- Sufficient bilateral temporal bone windows for ultrasound examination
- Conscious and able to cooperate with cerebral autoregulation assessment
- Willing to participate and provide informed consent
You will not qualify if you...
- Stenosis in vertebral artery, basilar artery, anterior cerebral artery, or posterior cerebral artery
- Bilateral internal carotid artery or M1 segment of middle cerebral artery stenosis (50-99%)
- Previous or planned intravascular intervention or endarterectomy
- Other intracranial diseases such as cerebral hemorrhage, brain tumors, aneurysms, or arteriovenous malformations
- Evidence of embolic stroke causes like atrial fibrillation or prosthetic valve surgery
- Arrhythmia, anemia, or hyperthyroidism affecting cerebral blood flow stability
- Dementia, severe anxiety, depression, or other mental illnesses
- Malignant tumors with expected life less than 2 years
- Participation in other clinical trials within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 30 days after ischemic cerebrovascular event
Participants undergo cerebral autoregulation assessments using neurovascular ultrasound to evaluate cerebral blood flow regulation after stroke or transient ischemic attack.
2 visits (in-person) within 0-3 days and 10-30 days after stroke onset
Duration - Up to 2 years
Participants are followed for up to two years to observe stroke recurrence and related clinical outcomes.
Periodic follow-up visits for clinical assessments and data collection
Trial Site Locations
Total: 1 location
1
the First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
Research Team
Y
Yi Yang, MD, PhD
Z
Zhenni Guo, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here