[미국 FDA의 승인 또는 허가를 받지 않은 기기의 시험] (CANDLE-AF)
Atrial fibrillation (AF) detected after ischemic stroke has immediate therapeutic implications, because it prompts a switch from antiplatelet to anticoagulant therapy. The conventional method used to screen for AF in patients whose stroke has no identified cause (cryptogenic stroke) is 24-hour Holter monitoring. CANDLE-AF is a multicenter, open-label, randomized trial comparing three noninvasive monitoring strategies over 12 months in patients with cryptogenic ischemic stroke or transient ischemic attack and no known AF: physician-directed standard care (at least one 24- to 72-hour Holter recording), scheduled 72-hour single-lead patch ECG monitoring repeated at 1, 3, 6, and 12 months, and twice-daily 30-second handheld single-lead ECG recording with a smartphone-based device for 12 months. The primary outcome is detection of AF lasting 30 seconds or longer within 12 months.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Daegu, 대한민국
- Daegu Catholic University Medical Center
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Seoul, 대한민국, 02447
- Kyung Hee University Hospital
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Seoul, 대한민국, 06273
- Yonsei University Health System, Severance Hospital
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Seoul
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Gangseo, Seoul, 대한민국, 07985
- Ewha Womans University Seoul Hospital
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Seongdong, Seoul, 대한민국, 04763
- Hanyang University Seoul Hospital
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Seoul, Seoul, 대한민국, 08308
- Korea University Guro Hospital
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Yangcheon, Seoul, 대한민국, 07985
- Ewha Womans University Mokdong Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18 years or older
- Ischemic stroke or transient ischemic attack with no identified cause (cryptogenic) after standard etiologic evaluation, admitted to the neurology department of a participating center
- No history of atrial fibrillation and no atrial fibrillation on the admission ECG or on continuous in-hospital telemetry
- Informed of implantable cardiac monitoring according to guidelines and declined it
- Written informed consent
Exclusion Criteria:
- Identified etiology of the stroke or transient ischemic attack
- Known or documented atrial fibrillation, including prior atrial fibrillation with restored sinus rhythm
- Pacemaker, implantable cardioverter-defibrillator, or other implanted electrical device
- Unable to use the smartphone-based recorder alone or with the help of others
- Pregnancy or lactation - Skin cancer, rash, skin disease, keloid, or injury at the patch site (current or history)
- Life expectancy less than 1 year
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Conventional Holter Monitoring Group
Physician-directed standard care, including at least one 24- to 72-hour Holter recording; further rhythm monitoring during the 12-month follow-up at the treating physician's discretion. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. |
At least one 24- to 72-hour ambulatory Holter recording; additional monitoring at the physician's discretion.
다른 이름들:
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실험적: Discontinuous Monitoring Group
Standard care plus twice-daily 30-second single-lead ECG recordings with a smartphone-based handheld recorder (KardiaMobile, AliveCor) for 12 months, transmitted through the smartphone application to a cardiac core laboratory. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. |
At least one 24- to 72-hour ambulatory Holter recording; additional monitoring at the physician's discretion.
다른 이름들:
Twice-daily 30-second handheld single-lead ECG recording for 12 months.
다른 이름들:
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실험적: Single-lead Continuous Patch Group
Standard care plus continuous 72-hour single-lead adhesive patch ECG monitoring (mobiCARE-MC100, Seers Technology) at 1, 3, 6, and 12 months after enrollment, transmitted to a cardiac core laboratory. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. |
At least one 24- to 72-hour ambulatory Holter recording; additional monitoring at the physician's discretion.
다른 이름들:
72-hour continuous single-lead patch ECG monitoring at 1, 3, 6, and 12 months (four sessions)
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Detection of atrial fibrillation lasting 30 seconds or longer
기간: Within 12 months after randomization
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First detection of AF lasting at least 30 seconds on any ECG recording (assigned device, Holter, 12-lead ECG, or clinical recording), confirmed by physician review |
Within 12 months after randomization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Recurrent ischemic stroke or transient ischemic attack
기간: Within 12 months after randomization
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Within 12 months after randomization
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Major adverse cardiovascular and cerebrovascular events (MACCE)
기간: Within 12 months after randomization
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composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death |
Within 12 months after randomization
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Initiation of oral anticoagulation following AF detection
기간: Within 12 months after randomization
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Initiation of oral anticoagulation following AF detection |
Within 12 months after randomization
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All-cause readmission
기간: Within 12 months after randomization
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Within 12 months after randomization
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All-cause death
기간: Within 12 months after randomization
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All-cause death |
Within 12 months after randomization
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Major bleeding
기간: Within 12 months after randomization
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Fatal or overt bleeding with a drop in hemoglobin level of at least 2 g/dL or requiring transfusion of at least 2 units packed blood cells, or critical anatomical site hemorrhage (e.g., intracranial, retroperitoneal) |
Within 12 months after randomization
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Junbeom Park, M.D., PhD., Ewha Womans University Mokdong Hospital
- 수석 연구원: Tae-Jin Song, MD, Ewha Womans University Seoul Hospital
- 수석 연구원: Dong-Hyeok Kim, MD, Ewha Womans University Seoul Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CANDLE-AF Trial
- NRF-2022R1A2C1093352 (기타 보조금/기금 번호: National Research Foundation of Korea)
- RS-2020-KD000234 (기타 보조금/기금 번호: Korea Medical Device Development Fund)
- RS-2025-25459963 (기타 보조금/기금 번호: Korea Health Industry Development Institute)
- KCT0005592 (레지스트리 식별자: CRIS)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual participant data underlying the published results, a data dictionary defining each field, and the statistical analysis code will be made available to qualified investigators.
IPD 공유 기간
Beginning 12 months after publication of the primary results, with no end date
IPD 공유 액세스 기준
Requests with a methodologically sound proposal should be directed to the corresponding author (parkjb@ewha.ac.kr). Access requires approval by the institutional review board of Ewha Womans University Medical Center and a signed data access agreement; data will be shared only for analyses within the scope of the informed consent.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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