Clinical trial NCT05028855: Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis
Official title: Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebrovascular Stroke
Cerebral Artery Stenosis
Keywords: cerebral atherosclerotic stenosis
ischemic stroke
transient ischemic attack
cerebral autoregulation
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: Shenzhen Second People's Hospital
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: The First Affiliated Hospital of University of South China
name: Eighth Affiliated Hospital, Sun Yat-sen University
name: The First Affiliated Hospital of Hebei North University
name: Qilu Hospital of Shandong University
name: The Affiliated Hospital of Qingdao University
name: The Affiliated Hospital of Yanbian University
First posted: 2021-08-31
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: Ischemic stroke is a tremendous public health burden that seriously endangers the health of Chinese population symptomatic cerebral atherosclerotic stenosis (sCAS) is responsible for about 33-50% of ischemic stroke in China and highly associated with the risk of stroke recurrence.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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:

* 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.
* 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

Primary outcomes:
measure: Stroke recurrence rate
timeFrame: two years
Secondary outcomes:
measure: The index of cerebral autoregulation
timeFrame: within 30 days ischemic cerebrovascular events onset
measure: ischemic cerebrovascular recurrence rate
timeFrame: two years
measure: The first onset time of composite endpoint events within 2 years
timeFrame: two years follow-up
measure: mRS and Barthel score
timeFrame: two years
measure: The first onset time of each individual part of composite endpoint events within 2 years
timeFrame: two years follow-up
measure: the NIHSS score
timeFrame: within 1 month
Other outcomes:
Locations:
city: Changchun
country: China
facility: the First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
name: Yi Yang, MD, PhD
role: STUDY_CHAIR
References: