Assessing brain blood flow regulation in patients with narrowed arteries
Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis
This study is trying to see if measuring how well blood flow is controlled in the brain can help predict future strokes in patients with narrowed arteries who have already had a stroke or mini-stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT05028855 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll 850 patients with symptomatic cerebral atherosclerotic stenosis to investigate the relationship between cerebral autoregulation and the recurrence of strokes. The study will utilize transcranial Doppler and servo-controlled plethysmography to assess cerebral autoregulation in patients who have experienced acute ischemic strokes or transient ischemic attacks. Measurements will be taken shortly after these events and during follow-up to determine how well cerebral autoregulation can predict future strokes. The study will also collect clinical, neuroimaging, and biochemical data to support its findings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with significant unilateral internal carotid artery or middle cerebral artery stenosis who have recently experienced a stroke or transient ischemic attack.
Not a fit: Patients with bilateral stenosis or stenosis in other major cerebral arteries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for predicting and preventing stroke recurrence in patients with cerebral artery stenosis.
How similar studies have performed: While the approach of assessing cerebral autoregulation in this context is promising, it has not been extensively tested in similar studies, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Changchun, Jilin
- the First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
Study contacts
- Study coordinator: Yi Yang, MD, PhD
- Email: doctor_yangyi@163.com
- Phone: 0086-13756661217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.