임상 레이더 AI | ||
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임상시험 NCT02036450 (LOOP)은(는) 심방세동, 뇌졸중, 고혈압, 당뇨병에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Atrial Fibrillation Detected by Continuous ECG Monitoring (LOOP) 6,000
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임상시험 NCT02036450 (LOOP)은(는) 심방세동, 뇌졸중, 고혈압, 당뇨병에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2014년 1월 1일에 시작되어 6,000명의 참여자와 함께 진행되었습니다. Rigshospitalet, Denmark이(가) 진행한 이 연구는 2021년 3월 1일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2021년 3월 10일에 갱신되었습니다.
간단한 개요
The LOOP study aims to determine whether screening for atrial fibrillation (AF) with implantable loop recorder and initiation of oral anticoagulation (OAC) if AF is detected will reduce the risk of stroke and systemic arterial embolism in patients with risk factors for stroke.
상세한 설명
Background:
Ischemic stroke is an increasing health problem world-wide (Heidenreich PA, et al. Circulation 2011; PMID 21262990). At least 20% of ischemic strokes are attributable to atrial fibrillation (AF) (Marini C, et al. Stroke J Cereb Circ 2005; PMID 15879330). Another 30% are so-called cryptogenic, possibly related to undiagnosed AF (Brachmann J, et al. Circ Arrhythm Electrophysiol 2015; PMID 26763225). In app...
더 보기공식 제목
Atrial Fibrillation Detected by Continuous ECG Monitoring Using Implantable Loop Recorder to Prevent Stroke in High-risk Individuals.
질환명
심방세동뇌졸중고혈압당뇨병출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- LOOP
- H-4-2013-025
- 13-135225 (기타 보조금/자금 번호) (Danish Strategic Research Council)
NCT 번호
실제 연구 시작일
2014-01
최신 업데이트 게시
2021-03-10
예상 연구 완료일
2021-03
계획된 등록 인원
6,000
연구종류
중재연구
단계/상
해당 없음
상태
완료
키워드
atrial fibrillation
cardiac arrhythmia
stroke
implantable loop recorder
bleeding
anticoagulation
hypertension
diabetes
heart failure
mortality
cardiac arrhythmia
stroke
implantable loop recorder
bleeding
anticoagulation
hypertension
diabetes
heart failure
mortality
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적ILR group Receive implantable loop recorder (ILR, Medtronic Reveal LINQ(TM)) with continuous monitoring, and will be followed by daily automated remote transmissions. Study visits are scheduled annually until the 4th visit, and furthermore, endpoints are collected via lookup in medical records and registries on at least an annual basis until the finalization of the trial. | Implantable loop recorder (Medtronic Reveal LINQ(TM)) The patients in the experimental arm receive an implantable loop recorder (Medtronic Reveal LINQ(TM)) with continuous monitoring, and are followed by daily automated remote transmissions. New arrhythmia episodes are reviewed daily by an experienced medical doctor. If AF lasting ≥6 minutes is detected and confirmed by at least two senior cardiologists, OAC is initiated. Decision about specific type of OAC, and possibl...더 보기 |
비개입Control group Followed according to standard care, i.e. by their general practitioner. Study visits are scheduled at inclusion and after 3 years. Furthermore, the participants are contacted by telephone after 1 and 2 years of follow-up, and endpoints are collected via lookup in medical records and registries on at least an annual basis until the finalization of the trial. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Time to adjudicated stroke or systemic arterial embolism | Time to the first of one of the components of the combined primary endpoint
* adjudicated stroke, or
* adjudicated systemic arterial embolism | At the completion of the event-driven trial, expected 4 years |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Time to adjudicated ischemic stroke/transient ischemic attack/systemic arterial embolism | Time to the first of one of the components of the combined endpoint
* adjudicated ischemic stroke, or
* adjudicated transient ischemic attack, or
* adjudicated systemic arterial embolism | At the completion of the event-driven trial, expected 4 years |
Time to adjudicated stroke, or systemic arterial embolism, or cardiovascular death | Time to the first of one of the components of the combined endpoint
* adjudicated stroke, or
* adjudicated systemic arterial embolism, or
* adjudicated cardiovascular death | At the completion of the event-driven trial, expected 4 years |
Time to adjudicated cardiovascular death | At the completion of the event-driven trial, expected 4 years | |
Time to death by any cause | At the completion of the event-driven trial, expected 4 years |
적격성 기준
연령대
노인
최소 연령
70 Years
참여 가능한 성별
전체
Age 70-90 years, and
Previously diagnosed with ≥1 of:
- Diabetes mellitus (type 1 or type 2, with or without medical therapy)
- Hypertension (with or without medical therapy)
- Heart failure
- Previous diagnosed stroke (previous transient ischemic attack is not considered an inclusion criterion)
- History of atrial fibrillation or flutter irrespective of type
- Cardiac pacemaker or defibrillator (with or without re-synchronization therapy)
- Contraindication to oral anticoagulation therapy
- Anticoagulation therapy; vitamin K antagonists, direct oral anticoagulants, or (low-molecular) heparins. Therapy with platelet inhibitors such as acetyl-salicylic acid, clopidogrel, persantine is not considered an exclusion criterion
- Renal failure treated with permanent dialysis
- Uncorrected congenital heart disease, or severe valvular stenosis, obstructive cardiomyopathy, active myocarditis, or constrictive pericarditis.
- On a waiting list for major surgery (cardiac, thoracic or abdominal)
- Cardiac or thoracic surgery has been performed within 3 months from inclusion
- Any major organ transplant (e.g. lung, liver, heart, or kidney)
- Cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months before randomization or clinical evidence of current malignancy with the following exceptions: Basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable, localized disease with a life expectancy of > 2.5 years in the opinion of the investigator)
- Life-expectancy shorter than 6 months
- Known to be human immunodeficiency virus (HIV) positive with an expected survival of less than 5 years due to HIV infection
- Recent (within 3 months) history of alcohol or drug abuse based on self-reporting
- Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, or interfere significantly with the subject participation in the study
- Unwillingness to participate or patient does not understand Danish language
Rigshospitalet, Denmark- 🏥Bispebjerg Hospi...
연구 책임자
Jesper Hastrup Svendsen, 책임연구자, Professor, MD, DMSc, FESC, Rigshospitalet, Denmark
연락처 정보가 없습니다.
1 1개국에 임상시험 장소
Rigshospitalet, Copenhagen, Denmark