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Recruiting NCT05028855

Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis

— Observational Cerebrovascular Stroke Cerebral Artery Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cerebral autoregulation assessment.
Who it may be relevant to
Registry conditions: Cerebrovascular Stroke, Cerebral Artery Stenosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Diagnostic test 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.

Primary outcome measures

  • Stroke recurrence rate [Time frame: two years]
Secondary outcome measures (6)
  • The index of cerebral autoregulation [Time frame: within 30 days ischemic cerebrovascular events onset]
  • ischemic cerebrovascular recurrence rate [Time frame: two years]
  • The first onset time of composite endpoint events within 2 years [Time frame: two years follow-up]
  • mRS and Barthel score [Time frame: two years]
  • The first onset time of each individual part of composite endpoint events within 2 years [Time frame: two years follow-up]
  • the NIHSS score [Time frame: within 1 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • the First Hospital of Jilin University — Changchun

Identifiers

NCT: NCT05028855 · CASCAS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗