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NCT Number: NCT05028855

Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location status: Recruiting

Location contact

Yi Yang

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Stroke recurrence rate

    Time frame: two years

    Ischemic cerebrovascular recurrence (TIA or ischemic stroke) within cerebral stenotic artery supplying area diagnosed by symptoms and imaging examinations.

Secondary outcomes

  1. The index of cerebral autoregulation

    Time frame: within 30 days ischemic cerebrovascular events onset

    Phase difference, gain and coherence of symptomatic cerebral atherosclerotic stenosis patients within 30 days ischemic cerebrovascular events onset.

  2. ischemic cerebrovascular recurrence rate

    Time frame: two years

    All ischemic cerebrovascular recurrence (TIA or ischemic stroke) within two years follow-up diagnosed by symptoms and imaging examinations.

  3. The first onset time of composite endpoint events within 2 years

    Time frame: two years follow-up

    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.

  4. mRS and Barthel score

    Time frame: two years

    The changes of mRS and Barthel score within 2 years

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

    Time frame: two years follow-up

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

  6. the NIHSS score

    Time frame: within 1 month

    The changes of NIHSS score from admission to discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Yang, MD, PhD

CONTACT

[email protected]

0086-13756661217

Zhenni Guo, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Collaborators

  • Eighth Affiliated Hospital, Sun Yat-sen University
  • Qilu Hospital of Shandong University
  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
  • Shenzhen Second People's Hospital
  • The Affiliated Hospital of Qingdao University
  • The Affiliated Hospital of Yanbian University
  • The First Affiliated Hospital of Hebei North University
  • The First Affiliated Hospital of University of South China
  • The First Affiliated Hospital with Nanjing Medical University

Registry information

Acronym: CASCAS

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
Aug 31, 2021
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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