Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorYi Yang
About this trial
In this multi-center prospective observational study within a cohort of symptomatic cerebral atherosclerotic stenosis (sCAS) patients, 850 subjects were planed to be enrolled 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ranging from 18 to 80, both genders
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
Disqualifiers
Vertebral artery (VA), basilar artery (BA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) stenosis; Bilateral internal carotid artery (ICA) or M1 segment of middle cerebral artery (MCA) stenosis(rate of stenosis ranging from 50-99%)
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.
Trial population
Patients with a diagnosis of symptomatic cerebral atherosclerotic stenosis, were recruited according to Inclusion Criteria, mostly from the First Hospital of Jilin University, and partly from other hospitals.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cerebral autoregulation assessment
Diagnostic testCerebral 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.
Treatment groups
850 Participants
are divided into 1 treatment groupGroup A: sCAS patients1 intervention
Trial outcomes
Primary outcomes
1
Stroke recurrence rate
Ischemic cerebrovascular recurrence (TIA or ischemic stroke) within cerebral stenotic artery supplying area diagnosed by symptoms and imaging examinations.
Time frame
two yearsSecondary outcomes
1
The index of cerebral autoregulation
Phase difference, gain and coherence of symptomatic cerebral atherosclerotic stenosis patients within 30 days ischemic cerebrovascular events onset.
Time frame
within 30 days ischemic cerebrovascular events onset2
ischemic cerebrovascular recurrence rate
All ischemic cerebrovascular recurrence (TIA or ischemic stroke) within two years follow-up diagnosed by symptoms and imaging examinations.
Time frame
two years3
The first onset time of composite endpoint events within 2 years
The composite endpoint events include fatal and nonfatal stroke (ischemic or hemorrhagic stroke), fatal and nonfatal myocardial infarction, transient ischemic attack (TIA) diagnosed by symptoms and imaging examinations.
Time frame
two years follow-up4
mRS and Barthel score
The changes of mRS and Barthel score within 2 years
Time frame
two yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yi Yang
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
Shenzhen Second People's Hospital
Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
The First Affiliated Hospital of University of South China
Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University
Collaborator
The First Affiliated Hospital of Hebei North University
Collaborator
Qilu Hospital of Shandong University
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
The Affiliated Hospital of Yanbian University
Collaborator
Source ClinicalTrials.gov