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

NCT ID: NCT04850001

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient Group

Asymptomatic intracranial stenosis patients who receive standard medical treatment without stenting

Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin

Intervention Type: 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.

Healthy Control

Healthy control are free from intracranial stenosis

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

WANG KAI

Director of medical psychological department, Anhui Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anhui Medical University

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kai Wang, PhD

Role: CONTACT

wangkai1964@126.com

+86-0551-62922263

Qiang Wei, PhD

Role: CONTACT

weiqiang19890914@126.com

+8618134516380

Facility Contacts

Qiang Wei, PhD

Role: primary

weiqiang19890914@126.com

+8618788836237

Other Identifiers

AHMU-ICAS-Best

Identifier Type: -

Identifier Source: org_study_id