- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00243906
Interventional Management of Stroke (IMS) II Study
연구 개요
상세 설명
The overall goal of Interventional Management of Stroke (IMS II) study is to refine thrombolytic therapy for patients with acute ischemic stroke who can be treated within three hours of stroke onset.
This multi-center, non-randomized pilot study will provide preliminary data about the benefits and risks of combined intravenous (IV) and intra-arterial (IA) recombinant tissue plasminogen activator (rtPA) and low-intensity ultrasound energy in ischemic stroke patients with baseline NIHSSS >/= 10 in whom intravenous treatment can be started within three hours of stroke onset. rt-PA is a thrombolytic, clot-dissolving drug.
The primary objectives for the study are to obtain reliable estimates of the effectiveness and safety of a treatment approach combining IV/IA rt-PA and ultrasound for stroke patients; and to determine if the estimated effectiveness of combined IV/IA rt-PA at 3 months-as compared to the 3 month outcome of placebo-treated patients in the NINDS rt-PA Stroke Trial-warrants proceeding to a large, phase III randomized trial.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Ohio
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Cincinnati, Ohio, 미국, 45267
- University of Cincinnati
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age: 18 through 80 years (i.e., candidates must have had their 18th birthday, but not had their 81st birthday)
- Initiation of intravenous rt-PA within 3 hours of onset of stroke symptoms. Time of onset is defined as the last time when the subject was witnessed to be at baseline (i.e., subjects who have stroke symptoms upon awakening will be considered to have their onset at beginning of sleep)
- An NIHSSS >/= 10 at the time that intravenous rt-PA is begun
Exclusion Criteria:
- History of stroke in the past 3 months
- Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arteriovenous malformation
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal
- Hypertension at time of treatment; systolic BP > 185 or diastolic > 110 mm Hg) or aggressive measures to lower blood pressure to below these limits are needed.
- Presumed septic embolus
- Presumed pericarditis, including pericarditis after acute myocardial infarction
- Recent (within 30 days) surgery or biopsy of parenchymal organ
- Recent (within 30 days) trauma, with internal injuries or ulcerative wounds
- Recent (within 90 days) severe head trauma or head trauma with loss of consciousness
- Any active or recent (within 30 days) hemorrhage
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency or oral anticoagulant therapy with INR > 1.5 or institutionally equivalent prothrombin time
- Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission
- Baseline lab values: glucose < 50mg/dl or > 400mg/dl, platelets <100,000, or Hct <25
- Subjects that require hemodialysis or peritoneal dialysis
- Subjects who have received heparin within 48 hours must have a normal partial thromboplastin time (PTT) to be eligible
- Subjects with an arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days
- Subjects with a seizure at onset of stroke
- Subjects with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
- Other serious, advanced, or terminal illness
- Any other condition that the investigator feels would pose a significant hazard to the subject if Activase (Alteplase) therapy is initiated
- Current participation in another research drug treatment protocol; subject cannot start another experimental agent until after 90 days
- Informed consent is not or cannot be obtained. For example, obtunded subjects are not automatically excluded from the study. However, if the next of kin or legal guardian (i.e., the individual legally empowered in the state where the consent is obtained) cannot provide consent, randomization and entry into the study could not proceed
CT Scan Exclusion Criteria:
- High density lesion consistent with hemorrhage of any degree
- Significant mass effect with midline shift
- Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan. Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Primary Safety Endpoint
기간: 36 hours after completion of rt-PA infusion
|
Development of intracerebral hematoma or hemorrhagic infarction with clinical deterioration likely to result in permanent disability or death, or other severe systemic bleeding complications such as groin hematoma, retroperitoneal hematoma, or gastrointestinal bleeding requiring transfusion of 3 units of blood replacement or major surgical intervention.
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36 hours after completion of rt-PA infusion
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Primary Angiographic Outcome
기간: 60 minutes after start of IA therapy
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The primary revascularization end point was complete (arterial occlusive lesion III) recanalization of the targeted arterial occlusion at 60 minutes after the start of IA rt-PA and ultrasound therapy,
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60 minutes after start of IA therapy
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Primary Outcome Measure
기간: 3 months following treatment
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modified Rankin Score of 0 or 1
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3 months following treatment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Joseph P. Broderick, MD, University of Cincinnati
- 수석 연구원: Thomas A. Tomsick, MD, University of Cincinnati
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- R01NS039160 (미국 NIH 보조금/계약)
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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