Impact of Carotid Artery Stenting on Brain Blood Flow and Cognitive Function
Effect of Carotid Artery Stent on Evoked Cerebral Blood Oxygenation and Neurocognitive Functioning
Shanghai Jiao Tong University Affiliated Sixth People's Hospital · NCT04651998
This study is testing if a procedure called carotid artery stenting can improve blood flow to the brain and help people with severe artery narrowing think better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 74 (estimated) |
| Ages | 35 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University Affiliated Sixth People's Hospital (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04651998 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of carotid artery stenting on cerebral blood oxygenation and neurocognitive function in patients with severe carotid artery stenosis. Patients aged 35-80 with confirmed high-grade stenosis will undergo cognitive assessments and functional near-infrared spectroscopy (fNIRS) before and after the stenting procedure, with follow-up evaluations at six months. The study aims to determine whether revascularization can improve blood flow to the brain and enhance cognitive performance. Cognitive tests such as the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) will be utilized to measure changes in cognitive function.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 35-80 with severe carotid artery stenosis who are asymptomatic or have experienced mild strokes.
Not a fit: Patients with severe stenosis or occlusion of other major arteries, significant heart issues, or diagnosed dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive functioning in patients with carotid artery stenosis through enhanced cerebral blood flow.
How similar studies have performed: While the approach of using stenting for cognitive improvement is being explored, this specific evaluation of fNIRS in relation to cognitive function post-stenting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 35-80 years old 2. Severe carotid stenosis (MRA or CTA confirmed stenosis rate of 70% - 99%, NASCET standard) 3. Asymptomatic or mild stroke (NIHSS ≤ 3) or TIA 4. Agree to participate in the clinical trial and sign the informed consent Exclusion Criteria: 1. Severe stenosis or occlusion of vertebrobasilar artery and other intracranial arteries (70% - 99%) 2. Left ventricular ejection fraction \< 50% or heart failure 3. Other types of dementia have been diagnosed 4. Severe depression, mental illness, epilepsy 5. Not cooperating with cognitive task evaluation
Where this trial is running
Shanghai
- Shanghai 6th People's Hospital — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Yueqi Zhu, PhD — Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Study coordinator: Jiangshan Deng, PhD
- Email: johnson120@126.com
- Phone: 862164369181
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.
Conditions: Carotid Artery Stenosis, carotid artery stent, functional near-infrared spectroscopy, vascular cognitive impairment,