- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05292729
Cognitive Function and Brain Connectivity in CAS Patients:a Rs-fMRI Study
Cognitive Function and Brain Connectivity in Carotid Artery Stenting Patients:a Rs-fMRI Study
연구 개요
상세 설명
Carotid artery stenting (CAS) can significantly decrease the incidence of ischemic stroke in patients with severe carotid artery stenosis has been confirmed in large randomized controlled studies (1, 2).Previous studies showed carotid artery stenosis is closely related to cognitive dysfunction, including asymptomatic carotid artery stenosis(≥70%).Cognitive impairment is one of the most serious problem facing the elderly. The impact on cognitive function in patients with CAS has been discussed by many researchers, however the effect still remained conflicting.
In past few years, several imaging techniques, such as resting-state functional MRI (R-fMRI), had been increasingly used to study cognitive impairment in humans. In this study, we evaluated the cognition performance in severe carotid artery stenosis patients undergoing CAS and explored the mechanisms underlying the cognition changes by the Rs-fMRI.
Inclusion criteria:
- age between 55 years and 80 years
- unilateral internal carotid artery stenotic degree ≥ 70%
- right-hand-dominant
- free of dementia, and depression
- modified Rankin Scale: 0 or 1
- education ≥6 years
- obtained written informed consent.
Exclusion criteria:
- contralateral internal carotid artery stenosis ≥ 50%
- posterior circulation diseases
- MMSE < 26, which is a cut-off value for mild cognitive impairment
- severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure)
- any contraindications for MRI scan (e.g., metal implants)
- Non atherosclerotic stenosis, such as dissection, vasculitis.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Renjie Ji, Master
- 전화번호: +86 13738101002
- 이메일: zjujirenjie@zju.edu.cn
연구 연락처 백업
- 이름: Hanfeng Chen, Master
- 전화번호: +86 18768115416
- 이메일: chf0106@foxmail.com
연구 장소
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 310016
- 모병
- The First Affiliated Hospital of Zhejiang University
-
수석 연구원:
- Benyan Luo, PhD
-
연락하다:
- 仁杰 计
- 전화번호: 13738101002
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- age between 55 years and 80 years
- unilateral internal carotid artery stenotic degree ≥ 70%
- right-hand-dominant
- free of stroke, TIA, dementia, and depression
- modified Rankin Scale: 0 or 1
- education ≥6 years
- obtained written informed consent.
Exclusion Criteria:
- contralateral internal carotid artery stenosis ≥ 50%
- posterior circulation diseases
- MMSE < 26, which is a cut-off value for mild cognitive impairment
- severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure and history of stroke)
- any contraindications for MRI scan (e.g., metal implants)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Montreal Cognitive Assessment, MOCA
기간: before CAS(within 1 week)
|
use MOCA to assess the cognition before CAS
|
before CAS(within 1 week)
|
Mini-mental State Examination,MMSE
기간: before CAS(within 1 week)
|
use MMSE to assess the cognition before CAS
|
before CAS(within 1 week)
|
Montreal Cognitive Assessment, MOCA
기간: 3 months after CAS
|
use MOCA to assess the cognition after CAS
|
3 months after CAS
|
Mini-mental State Examination,MMSE
기간: 3 months after CAS
|
use MMSE to assess the cognition after CAS
|
3 months after CAS
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Digit Symbol Test
기간: before CAS(within 1 week)
|
use to assess the cognition before CAS
|
before CAS(within 1 week)
|
Digit Symbol Test
기간: 3 months after CAS
|
use to assess the cognition after CAS
|
3 months after CAS
|
Trail Making Test A/B
기간: before CAS(within 1 week)
|
use to assess the cognition before CAS
|
before CAS(within 1 week)
|
Trail Making Test A/B
기간: 3 months after CAS
|
use to assess the cognition after CAS
|
3 months after CAS
|
digital span test
기간: before CAS(within 1 week)
|
use to assess the cognition before CAS
|
before CAS(within 1 week)
|
digital span test
기간: 3 months after CAS
|
use to assess the cognition after CAS
|
3 months after CAS
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Benyan Luo, PhD, Zhejiang University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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