NCT04850001

Cognitive Decline in Asymptomatic Intracranial Stenosis Patients: A 1-Year Follow-Up Study

Investigating the Changes of the Cognition in Asymptomatic Intracranial Stenosis Patients After 1-Year Standard Medical Treatment Without Stenting

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To investigate the cognitive decline after standard medical treatment without stenting in Asymptomatic Intracranial Stenosis patients and the underlying neural mechanism by fMRI.

Detailed description

All participants underwent a medical evaluation that included routine laboratory studies before and after 1-year standard medical treatment. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests and Magnetic Resonance imaging scan in multimodalities within 7 days after admission and after 1-year when patients received standard medical treatment at the First Affiliated Hospital of AnHui Medical University. participants were randomly allocated to patient group and the control group.There are about 20 patients and 20 healthy controls in this study. Firstly, a series of neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the memory as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA,MMSE, DS, Stroop test, TMT, VFT), memory (CAVLT), emotion (HAMA-17,HAMD-14), behavioral and psychological symptoms(NPI). All the tests are conducted in two days. The patients had receiving a magnetic resonance imaging scan in multi-modalities. After 1-year standard medical treatment,the patients participants were interviewed to obtain the same assessment and magnetic resonance imaging scan in multi-modalities as before. Patients are instructed to focus their answers on the past 15 days. The clinical symptom of participants were followed 6 and 12 months after the admission. Afterwards, they were unblinded by the study coordinator.

Conditions

• Magnetic Resonance Imaging
• Asymptomatic Intracranial Stenosis
• Medical Treatment

Interventions

Type	Name	Description
DRUG	Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin	All patients received standard medical management, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.

Timeline

• Start date: 2020-09-10
• Primary completion: 2022-12-31
• Completion: 2025-12-31
• First posted: 2021-04-20
• Last updated: 2021-04-20

Locations

1 site across 1 country: China