Clinical Trials Directory

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UnknownNCT04651998

Effect of Carotid Artery Stent on Evoked Cerebral Blood Oxygenation and Neurocognitive Functioning

Status
Unknown
Phase
Study type
Observational
Enrollment
74 (estimated)
Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Academic / Other
Sex
All
Age
35 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Cerebral hemodynamic compromise from internal carotid artery stenosis may be a cause of vascular cognitive impairment that is amenable to treatment by revascularization. The effect of carotid artery stent on evoked cerebral blood oxygenation and neurocognitive functioning will be evaluated by functional near-infrared spectroscopy. Carotid artery stent could benefit cerebral blood oxygenation after stent and improving neurocognitive functioning after 6 months.

Detailed description

Patients with high grade internal carotid artery stenosis intended to carotid artery stent are brought to this study. Global cognitive function and evoked cerebral blood oxygenation are evaluated before and after stent, followed up at 6 months later. Mini-Mental State Examination(MMSE) and Montreal Cognitive Assessment (MoCA) are used for the global cognitive test. Evoked cerebral blood oxygenation is evaluated using functional near-infrared spectroscopy(fNIRS) through performing mental task( N-back task, Go/no go task, and verbal fluency task ). All the patients from different centers are conducted the test at the only main center by one doctor. The parameter of fNIRS and score of cognitive test of each patient are compared before and after stent.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMMSE, MoCA, functional near-infrared spectroscopyMMSE and MoCA are used for cognitive test before carotid artery stent implant and 6 months later. Cerebral blood oxygenation is evaluated by functional near-infrared spectroscopy under the mental task before and after revascularization within one week, 6 months later respectively.

Timeline

Start date
2021-05-01
Primary completion
2024-09-30
Completion
2024-12-30
First posted
2020-12-03
Last updated
2024-05-29

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04651998. Inclusion in this directory is not an endorsement.