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

NCT04850001 | Unknown

• 1 other identifier: AHMU-ICAS-Best
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Magnetic Resonance Imaging; Asymptomatic Intracranial Stenosis; Medical Treatment

Keywords

Magnetic Resonance Imaging; Asymptomatic Intracranial Stenosis patients; Cognitive function; Medical Treatment

Outcome Measures

Primary Outcomes (1)

• Changes in Memory

  The changes in Memory function will constitute the major research outcome measure used to assess response to standard medical treatment.

  baseline, 1-year after medical treatment

Secondary Outcomes (8)

• The changes in MMSE(Mini Mental State Examination)

  baseline, 1-year after medical treatment

• DST (Digital Span Test; Forward and Backward)

  baseline, 1-year after medical treatment

• TMT (Trail Making Test)

  baseline, 1-year after medical treatment

• HAMD (Hamilton Depression Scale)

  baseline, 1-year after medical treatment

• HAMA (Hamilton Anxiety Scale)

  baseline, 1-year after medical treatment

Study Arms (2)

Patient Group

Asymptomatic intracranial stenosis patients who receive standard medical treatment without stenting

Drug: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin

Healthy Control

Healthy control are free from intracranial stenosis

Interventions

Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin DRUG

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.

Patient Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with intracranial stenosis which was defined as stenosis of 50% or more in Intracranial segment of internal carotid artery and middle cerebral artery (MCA) without history of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).

You may qualify if:

• Patients with intracranial stenosis which was defined as stenosis of 50% or more in Intracranial segment of internal carotid artery and middle cerebral artery (MCA).
• The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).

You may not qualify if:

• History of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.
• Organic brain defects on T1 or T2 images.
• Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
• Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. History of substance abuse within the last 6 months.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

RECRUITING

MeSH Terms

Interventions

Aspirin; Clopidogrel; Atorvastatin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Kai Wang, PhD

CONTACT

+86-0551-62922263; wangkai1964@126.com

Qiang Wei, PhD

CONTACT

+8618134516380; weiqiang19890914@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of medical psychological department, Anhui Medical University

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: September 10, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)