Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis

NCT05028855 | Recruiting DMC

• 1 other identifier: CASCAS
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Stroke; Cerebral Artery Stenosis

Keywords

cerebral atherosclerotic stenosis; ischemic stroke; transient ischemic attack; cerebral autoregulation

Outcome Measures

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.

  two years

Secondary Outcomes (6)

• The index of cerebral autoregulation

  within 30 days ischemic cerebrovascular events onset

• ischemic cerebrovascular recurrence rate

  two years

• The first onset time of composite endpoint events within 2 years

  two years follow-up

• mRS and Barthel score

  two years

• The first onset time of each individual part of composite endpoint events within 2 years

  two years follow-up

Study Arms (1)

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

Interventions

Cerebral autoregulation assessment DIAGNOSTIC_TEST

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.

sCAS patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yi Yang: lead
• 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

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Yi Yang, MD, PhD

  Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

  STUDY CHAIR

Central Study Contacts

Yi Yang, MD, PhD

CONTACT

0086-13756661217; doctor_yangyi@163.com

Zhenni Guo, MD

CONTACT

zhen1ni2@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: August 31, 2021
• Study Start: January 14, 2017
• Primary Completion: December 24, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CN (1)