- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05907629
두개내혈관죽상동맥협착-자기공명영상에서 항응고 및 항혈소판 요법의 비교 (CAPTIVA-MRI)
2024년 4월 8일 업데이트: Yale University
CAPTIVA-MRI는 CAPTIVA 시험[약 115개의 StrokeNet 사이트에서 수행된 3군, 이중 맹검 3상 시험으로 70-99% 두개내 죽상경화성 협착증(ICAS ) 아스피린 + 티카그렐러, 클로피도그렐 또는 리바록사반.]
이 보조 연구의 주요 목표는 MRI 바이오마커가 최상의 의료 관리에 실패한 ICAS 환자를 잠재적으로 식별할 수 있는지 확인하는 것입니다.
CAPTIVA-MRI 연구는 CAPTIVA 시험 설계 및 구현을 활용하여 차세대 ICAS 시험 및 ICAS 환자 관리를 알리고 촉진할 정보를 수집합니다.
연구 개요
연구 유형
관찰
등록 (추정된)
300
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Adam H. de Havenon, MD
- 전화번호: 203-785-4085
- 이메일: adam.dehavenon@yale.edu
연구 연락처 백업
- 이름: Ka-Ho Wong, MBA
- 전화번호: 801-585-7575
- 이메일: ka-ho.wong@hsc.utah.edu
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35233
- University of Alabama Hospital
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수석 연구원:
- Ekaterina Bakradze
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연락하다:
- Tammy Davis
- 전화번호: 205-975-8572
- 이메일: trdavis@uabmc.edu
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Florida
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Jacksonville, Florida, 미국, 32207
- Baptist Medical Center Jacksonville
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Miami, Florida, 미국, 33136
- Jackson Memorial Hospital, Miami
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수석 연구원:
- Victor Del Brutto
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연락하다:
- Erick Lopez
- 전화번호: 305-243-6542
- 이메일: exl758@med.miami.edu
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연락하다:
- Iszet Campo-Bustillo
- 이메일: lIcampo@med.miami.edu
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Illinois
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Chicago, Illinois, 미국, 60637
- University of Chicago Medical Center
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수석 연구원:
- Tareq Kass-Hout
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연락하다:
- Eric Kaplan
- 전화번호: 773-702-1848
- 이메일: Eric.Kaplan@bsd.uchicago.edu
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연락하다:
- Elida Romo
- 전화번호: 773-702-2039
- 이메일: eromo1@bsd.uchicago.edu
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Chicago, Illinois, 미국, 60612
- University of Illinois Hospital
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수석 연구원:
- Ali Alaraj, MD
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연락하다:
- Christine Maley
- 전화번호: 312-996-2949
- 이메일: cmaley@uic.edu
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연락하다:
- Linda Rose-Finnell
- 전화번호: 312-355-2050
- 이메일: lfinnell@uic.edu
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Missouri
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Saint Louis, Missouri, 미국, 63108
- Barnes Jewish Hospital
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연락하다:
- Jill Newgent
- 이메일: newgentj@wustl.edu
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수석 연구원:
- Yan Wang, MD
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연락하다:
- Jenny Babka
- 이메일: babkaj@wustl.edu
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New York
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Buffalo, New York, 미국, 14203
- Buffalo General Medical Center
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연락하다:
- Annemarie Crumlish
- 이메일: ac35@buffalo.edu
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수석 연구원:
- Amit Kandel
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Manhasset, New York, 미국, 11030
- North Shore University Hospita
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연락하다:
- Kirendra Pasram
- 이메일: kpasram1@northwell.edu
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수석 연구원:
- Rohan Arora
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
최근 뇌졸중이 있고 CAPTIVA에 등록된 ICAS 환자.
설명
포함 기준:
- CAPTIVA 시험 등록: 두개내 ICA, MCA, BA 또는 VA의 70-99% 협착증에 이차적으로 30일 이내에 비장애 증상성 허혈성 경색 뇌졸중
- CAPTIVA 등록 후 14일 이내에 기본 연구 MRI를 얻을 수 있는 능력
제외 기준:
- American College of Radiology 가이드라인62에 따른 심박 조율기 또는 기타 MRI 금기 사항을 포함하여 MRI를 받을 수 없거나 받을 의사가 없는 사람
- eGFR<30 ml/min/1.73m2인 가돌리늄 조영제 알레르기 또는 급성 또는 만성 신장 질환
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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CAPTIVA-MRI 그룹
아스피린 + 티카그렐로, 클로피도그렐 또는 리바록사반에 대한 70-99% 두개내 죽상경화성 협착증(ICAS)에 기인한 뇌졸중이 있는 CAPTIVA 환자.
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기준선 및 12개월 추적 조사에서 CAPTIVA 연구에 대한 추가 MRI
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
인덱스 뇌졸중의 혈관 영역에서 재발성 허혈성 뇌졸중의 신뢰할 수 있는 예측인자로 ICAS 혈역학 및 플라크 MRI 바이오마커를 설정합니다.
기간: 12 개월
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인덱스 뇌졸중 동맥의 혈관 영역에서 증상이 있는 경색으로 정의되는 재발성 허혈성 뇌졸중.
이 결과는 허혈성 뇌졸중에 대한 American Heart Association의 정의를 사용하여 CAPTIVA에서 중심적으로 판정됩니다.
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12 개월
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: David Liebeskind, MD, University of California, Los Angeles
- 수석 연구원: Sepideh Amin-Hanjani, MD, University Hospitals
- 수석 연구원: Rano Chatterjee, MD, Washington University School of Medicine
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2024년 4월 1일
기본 완료 (추정된)
2029년 3월 31일
연구 완료 (추정된)
2029년 3월 31일
연구 등록 날짜
최초 제출
2023년 6월 7일
QC 기준을 충족하는 최초 제출
2023년 6월 7일
처음 게시됨 (실제)
2023년 6월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2024년 4월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2024년 4월 8일
마지막으로 확인됨
2024년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00050939
- 1UG3NS130228-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .
MRI에 대한 임상 시험
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