Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis
NCT ID: NCT05028855
Last Updated: 2024-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
850 participants
OBSERVATIONAL
2017-01-14
2026-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Remote Ischemic Conditioning and Dynamic Cerebral Autoregulation in Patients With Intracranial and Extracranial Arteriosclerosis
NCT05599009
Combined Coronary and Cerebral Angiography and Intervention for Coronary and Cerebrovascular Atherosclerosis
NCT02315924
Vascular Ultrasound Screening in Patients With Ischemic Cerebrovascular Disease: a Multi-center Registry Study
NCT02397655
a Cohort Study of Ischemic Cerebrovascular Disease
NCT05922540
Ultrasound Evaluation of Carotid Artery Atherosclerotic Plaques and Recanalization
NCT03786666
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Cerebral autoregulation (CA) is the main protective mechanism that modulates cerebral blood flow to satisfy regional cerebral perfusion demands despite of variations in arterial blood pressure (ABP). Thus, CA supposed to be particularly considered when choosing individual therapeutic strategy in sCAS patients. In clinical practice, applying transcranial Doppler combined with servo-controlled plethysmograph assessing CA has been proved a feasible method in cerebral atherosclerotic stenosis patients. Especially in those severe stenosis patients, CA is probably compromised in varying degrees, whereas whether and to what extent CA parameters have the capability to predict stroke recurrence has not been illustrated.
Thus, the aim of the study was to assess CA after acute ischemic stroke or transient ischemic attack within 2 years follow-up to explore the relationship between CA and stroke recurrence and determine the threshold values of CA parameter to predict stroke recurrence. CA measurement will be performed at 0-3 and 10-30 days after ischemic cerebrovascular events. Clinical information, neuroimaging data, biochemical examinations and follow-up information will be collected and recorded in case report form (CRF) once signing of informed consent.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
sCAS patients
Investigators plan to enroll 850 patients of symptomatic cerebral atherosclerotic stenosis (sCAS) for cerebral autoregulation assessment to explore the relationship between cerebral autoregulation (CA) and stroke recurrence, determine the threshold values of CA parameter for predicting stroke recurrence associated with particular stenosis.
Cerebral autoregulation assessment
Cerebral autoregulation assessment will be conducted by specialized neurovascular ultrasound doctors during 0-3 and 10-30 days after stroke onset.The recorded data will be stored for further cerebral autoregulation analysis.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cerebral autoregulation assessment
Cerebral autoregulation assessment will be conducted by specialized neurovascular ultrasound doctors during 0-3 and 10-30 days after stroke onset.The recorded data will be stored for further cerebral autoregulation analysis.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Unilateral internal carotid artery (ICA) or M1 segment of middle cerebral artery (MCA) stenosis (rate of stenosis ranging from 50-99%)
* Acute ischemic cerebrovascular events (TIA or ischemic stroke) within cerebral stenotic artery supplying area
* Onset of disease \<30 d before enrollment
* Modified Ranking Scale (mRS) ≤1 before stroke onset
* National Institutes of Health Stroke Scale (NIHSS) ≤20
* Sufficient bilateral temporal bone windows for insonation of the middle cerebral artery
* Be conscious, and able to cooperate with CA assessment
* Willing to participate and sign the informed consent
Exclusion Criteria
* Patients who have received or plan to undergo intravascular interventional treatment/endarterectomy
* Other intracranial diseases, including cerebral hemorrhage (primary or secondary), intracranial neoplasm, aneurysm, arteriovenous malformation, etc.
* Evidence for embolic stroke, such as atrial fibrillation, prosthetic valve surgery, and suspected endocarditis, etc.
* Arrhythmia, anemia and hyperthyroidism which may influence the stability of cerebral blood flow diagnosed by two physicians by electrocardiogram and laboratory tests.
* Dementia, severe anxiety, depression, and other mental diseases
* Malignant neoplasm and expected lifetime \<2 years
* Enrolled in other clinical trails within 6 months
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shenzhen Second People's Hospital
OTHER
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
The First Affiliated Hospital of University of South China
OTHER
Eighth Affiliated Hospital, Sun Yat-sen University
OTHER
The First Affiliated Hospital of Hebei North University
OTHER
Qilu Hospital of Shandong University
OTHER
The Affiliated Hospital of Qingdao University
OTHER
The Affiliated Hospital of Yanbian University
OTHER
Yi Yang
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yi Yang
Associated Dean of First Hospital of Jilin University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yi Yang, MD, PhD
Role: STUDY_CHAIR
Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
the First Hospital of Jilin University
Changchun, Jilin, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yi Yang
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CASCAS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.