Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis (CASCAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebrovascular Stroke; Cerebral Artery Stenosis
• Intervention / Treatment: Diagnostic test: Cerebral autoregulation assessment

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.

• Study Type: Observational
• Enrollment (Estimated): 850

Contacts and Locations

• Study Contact: Name: Yi Yang, MD, PhD; Phone Number: 0086-13756661217; Email: doctor_yangyi@163.com
• Study Contact Backup: Name: Zhenni Guo, MD; Email: zhen1ni2@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Yi Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke recurrence rate	Ischemic cerebrovascular recurrence (TIA or ischemic stroke) within cerebral stenotic artery supplying area diagnosed by symptoms and imaging examinations.	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The index of cerebral autoregulation	Phase difference, gain and coherence of symptomatic cerebral atherosclerotic stenosis patients within 30 days ischemic cerebrovascular events onset.	within 30 days ischemic cerebrovascular events onset
ischemic cerebrovascular recurrence rate	All ischemic cerebrovascular recurrence (TIA or ischemic stroke) within two years follow-up diagnosed by symptoms and imaging examinations.	two years
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.	two years follow-up
mRS and Barthel score	The changes of mRS and Barthel score within 2 years	two years
The first onset time of each individual part of composite endpoint events within 2 years	The first onset time of each individual part of composite endpoint events within 2 years	two years follow-up
the NIHSS score	The changes of NIHSS score from admission to discharge	within 1 month

Collaborators and Investigators

• Sponsor: Yi Yang
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Qilu Hospital of Shandong University; The Affiliated Hospital of Qingdao University; The First Affiliated Hospital of University of South China; Shenzhen Second People's Hospital; Shanghai Jiao Tong University Affiliated Sixth People's Hospital; The Affiliated Hospital of Yanbian University; The First Affiliated Hospital of Hebei North University; Eighth Affiliated Hospital, Sun Yat-sen University
• Investigators: Study Chair: Yi Yang, MD, PhD, Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2017
• Primary Completion (Estimated): December 24, 2025
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: August 29, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ischemic stroke; transient ischemic attack; cerebral autoregulation; cerebral atherosclerotic stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Stroke; Constriction, Pathologic
• Other Study ID Numbers: CASCAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No