30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event (EMBRACE)
2018년 10월 3일 업데이트: Dr. David Gladstone, Sunnybrook Health Sciences Centre
30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event: A Randomized Controlled Trial
Atrial fibrillation is the most common cardiac cause of ischemic stroke.
Detecting atrial fibrillation after a stroke or TIA is critical because highly effective secondary stroke prevention therapy is available for individuals who are recognized to have atrial fibrillation.
However, atrial fibrillation is likely under-diagnosed after stroke and TIA because atrial fibrillation is often difficult to detect as it is frequently paroxysmal and asymptomatic, and patients do not routinely undergo prolonged screening.
The purpose of this study is to determine the diagnostic yield of a novel 30-day cardiac event monitor compared to a repeat 24-hour Holter monitor for detecting occult paroxysmal atrial fibrillation in patients with a recent ischemic stroke or TIA of undetermined etiology after completion of a standard clinical stroke work-up (including an initial negative Holter monitor.)
연구 개요
상태
알려지지 않은
연구 유형
중재적
등록 (예상)
564
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alberta
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Calgary, Alberta, 캐나다
- Foothills Medical Centre
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Edmonton, Alberta, 캐나다
- Grey Nuns Hospital
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Edmonton, Alberta, 캐나다
- Walter C. Mackenzie Health Sciences Centre
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British Columbia
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Vancouver, British Columbia, 캐나다
- Vancouver Hospital and Health Sciences Centre
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Victoria, British Columbia, 캐나다
- Vancouver Island Health Research Centre (VIHA)
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Ontario
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Hamilton, Ontario, 캐나다
- Hamilton Health Sciences Centre
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Kingston, Ontario, 캐나다
- Kingston General Hospital
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London, Ontario, 캐나다
- London Health Sciences Centre
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London, Ontario, 캐나다
- Robarts Research Institute
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Ottawa, Ontario, 캐나다
- Ottawa Hospital Research Institute -The Ottawa Hospital
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Thunder Bay, Ontario, 캐나다
- Thunder Bay Regional HSC
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Toronto, Ontario, 캐나다
- St. Michael's Hospital
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Toronto, Ontario, 캐나다
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, 캐나다
- UHN / Toronto Western Hospital
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Toronto, Ontario, 캐나다
- York Central Hospital
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Quebec
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Montreal, Quebec, 캐나다
- Montreal General Hospital
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Quebec City, Quebec, 캐나다
- CHA-Hôpital de l'Enfant-Jesus
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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
55년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion:
Diagnosis of the index event* made by a stroke specialist of an acute ischemic stroke or TIA (WHO definition) of undetermined etiology (cryptogenic) occurring within the previous 6 months (180 days).The event must be either:
- an embolic arterial ischemic stroke confirmed by neuroimaging; or
- a transient ischemic attack, defined as involving a focal unilateral motor deficit, speech/language deficit, or hemianopia, with symptom duration <24 hours (note: amaurosis fugax/transient monocular blindness, pure sensory spells, isolated vertigo spells, etc. do not qualify for enrolment given the potential for misdiagnosis of such events).
Patient meets the following:
- At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work-up, and no ECGs have shown any episodes of atrial fibrillation or atrial flutter, and;
- A Holter monitor has already been obtained as part of the routine clinical post-stroke/TIA work-up, and does not show any episodes of atrial fibrillation or atrial flutter ≥30 seconds.
- The patient is being actively investigated for the etiology of the stroke/TIA event and additional cardiac monitoring is desired to screen further for the possibility of occult paroxysmal atrial fibrillation/flutter, i.e. patients selected for this study are those for whom the investigator, in his/her clinical judgment, would consider ordering a repeat Holter monitor as part of clinical care.
The following diagnostic tests have already been completed as part of clinical routine post-stroke/TIA:
- brain imaging with CT or MRI,
- vascular imaging of the extracranial and intracranial circulation with either CT angiography or MR angiography to exclude significant large vessel occlusive disease as the most likely mechanism for the index ischemic event (carotid Doppler ultrasound is acceptable for those presenting with anterior circulation ischemic events),
- transthoracic (or transesophageal) echocardiography to exclude thrombus or other structural heart disease that in the opinion of the investigator is the most likely cause for the stroke/TIA event. [Note: If a baseline echocardiogram cannot be obtained clinically after the index event and prior to study enrollment, then it is acceptable for study purposes for an echocardiogram to be obtained after patient enrollment into the study but prior to the 90-day follow-up visit. Alternatively, an echocardiogram already performed within one year prior to study enrollment may serve as the baseline echocardiogram for study purposes.]
- Age 55 years or older [Note: Participants aged 55-59 years should have imaging confirmation of the index stroke/TIA event with an embolic imaging pattern of acute cerebral ischemia]
- Informed consent from the patient (or from a legally authorized representative if the patient is not competent, e.g. due to stroke-related cognitive impairment, aphasia, or anosognosia).
- The patient is expected to survive at least 6 months.
The patient has a valid provincial health insurance number.
- The index event will be defined as the event leading to medical presentation
Exclusion:
- Any previously documented atrial fibrillation or atrial flutter, i.e. a past history of atrial fibrillation/flutter or atrial fibrillation/flutter detected on ECG, Holter, or telemetry following the index stroke/TIA event (a remote history of transient perioperative atrial fibrillation is not exclusionary
- Exclusively retinal stroke or TIA event.
- A most responsible etiological diagnosis for the qualifying stroke/TIA event has already been determined, i.e. probable small-vessel (lacunar) disease, probable large vessel disease, cervicocephalic artery dissection, venous sinus thrombosis, hypercoagulable states, or other known cause.
- Planned carotid endarterectomy within 90 days.
- Patient is already currently participating in a clinical trial involving an investigational medication or device.*
- Any finding on echocardiography for which there is already an evidence-based indication for long-term anticoagulation (e.g. mechanical heart valve, thrombus, etc.).
- Endocarditis
- Pacemaker or ICD device.
- Patients with known skin reactions to synthetic polymers or to silver. (Some people who display sensitivity to silver jewellery are sensitive to the impurities present in silver alloys and not to the silver itself. These people may participate.)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: repeat 24-hour Holter monitor
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Repeat standard 24-hour Holter Monitor
다른 이름들:
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실험적: 30-day ambulatory cardiac event monitor
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Patients will be fitted with dry electrode belt (including cardiac event monitor)and instructed to wear the device for as many hours(waking and sleeping) each day as possible, for a total of 30 days.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds, as assessed at the 90 day follow-up
기간: 90 days
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90 days
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2차 결과 측정
결과 측정 |
기간 |
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Atrial fibrillation <30 seconds
기간: 90 days
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90 days
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Atrial flutter <30 seconds
기간: 90 days
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90 days
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Non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of atrial fibrillation)
기간: 90 days
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90 days
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Proportion of patients in each group that are prescribed oral anticoagulation, as assessed at the 90-day follow-up
기간: 90 days
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90 days
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Patient adherence with 30-day monitoring: average proportion of days wearing the monitor per patient, and the percentage of patients wearing the monitor for >75% of the target period
기간: 90 days
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90 days
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1 and 2-year recurrence of ischemic stroke/TIA, death, hemorrhagic stroke, major adverse bleeding event, detection of atrial fibrillation outside of the study protocol
기간: 2 years
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2 years
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composite endpoint of: (1) AF >30 seconds, (2) non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of AF), or (3) atrial flutter.
기간: 90 days
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90 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: David J Gladstone, MD, PhD, FRCPC, Sunnybrook Health Sciences Centre
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Gladstone DJ, Dorian P, Spring M, Panzov V, Mamdani M, Healey JS, Thorpe KE; EMBRACE Steering Committee and Investigators. Atrial premature beats predict atrial fibrillation in cryptogenic stroke: results from the EMBRACE trial. Stroke. 2015 Apr;46(4):936-41. doi: 10.1161/STROKEAHA.115.008714. Epub 2015 Feb 19.
- Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Cote R, Sharma M, Blakely JA, Shuaib A, Hachinski V, Coutts SB, Sahlas DJ, Teal P, Yip S, Spence JD, Buck B, Verreault S, Casaubon LK, Penn A, Selchen D, Jin A, Howse D, Mehdiratta M, Boyle K, Aviv R, Kapral MK, Mamdani M; EMBRACE Investigators and Coordinators. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77. doi: 10.1056/NEJMoa1311376.
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
2009년 5월 1일
기본 완료 (실제)
2014년 4월 1일
연구 완료 (예상)
2018년 10월 30일
연구 등록 날짜
최초 제출
2009년 2월 18일
QC 기준을 충족하는 최초 제출
2009년 2월 18일
처음 게시됨 (추정)
2009년 2월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 10월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 10월 3일
마지막으로 확인됨
2018년 10월 1일
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. .