[Prøving av enhet som ikke er godkjent eller godkjent av U.S. FDA] (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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Daegu, Sør -Korea
- Daegu Catholic University Medical Center
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Seoul, Sør -Korea, 02447
- Kyung Hee University Hospital
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Seoul, Sør -Korea, 06273
- Yonsei University Health System, Severance Hospital
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Seoul
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Gangseo, Seoul, Sør -Korea, 07985
- Ewha Womans University Seoul Hospital
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Seongdong, Seoul, Sør -Korea, 04763
- Hanyang University Seoul Hospital
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Seoul, Seoul, Sør -Korea, 08308
- Korea University Guro Hospital
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Yangcheon, Seoul, Sør -Korea, 07985
- Ewha Womans University Mokdong Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
Twice-daily 30-second handheld single-lead ECG recording for 12 months.
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
72-hour continuous single-lead patch ECG monitoring at 1, 3, 6, and 12 months (four sessions)
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Detection of atrial fibrillation lasting 30 seconds or longer
Tidsramme: Within 12 months after randomization
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrent ischemic stroke or transient ischemic attack
Tidsramme: Within 12 months after randomization
|
Within 12 months after randomization
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|
|
Major adverse cardiovascular and cerebrovascular events (MACCE)
Tidsramme: Within 12 months after randomization
|
composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death |
Within 12 months after randomization
|
|
Initiation of oral anticoagulation following AF detection
Tidsramme: Within 12 months after randomization
|
Initiation of oral anticoagulation following AF detection |
Within 12 months after randomization
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All-cause readmission
Tidsramme: Within 12 months after randomization
|
Within 12 months after randomization
|
|
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All-cause death
Tidsramme: Within 12 months after randomization
|
All-cause death |
Within 12 months after randomization
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Major bleeding
Tidsramme: Within 12 months after randomization
|
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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Junbeom Park, M.D., PhD., Ewha Womans University Mokdong Hospital
- Hovedetterforsker: Tae-Jin Song, MD, Ewha Womans University Seoul Hospital
- Hovedetterforsker: Dong-Hyeok Kim, MD, Ewha Womans University Seoul Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Hjertesykdommer
- Arytmier, hjerte
- Hjerneiskemi
- Slag
- Patologiske tilstander, tegn og symptomer
- Iskemisk hjerneslag
- Iskemisk angrep, forbigående
- Atrieflimmer
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Diagnostiske teknikker, kardiovaskulær
- Hjertefunksjonstester
- Elektrodiagnose
- Overvåking, fysiologisk
- Elektrokardiografi
- Overvåking, ambulerende
- Elektrokardiografi, ambulerende
Andre studie-ID-numre
- CANDLE-AF Trial
- NRF-2022R1A2C1093352 (Annet stipend/finansieringsnummer: National Research Foundation of Korea)
- RS-2020-KD000234 (Annet stipend/finansieringsnummer: Korea Medical Device Development Fund)
- RS-2025-25459963 (Annet stipend/finansieringsnummer: Korea Health Industry Development Institute)
- KCT0005592 (Registeridentifikator: CRIS)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
Beginning 12 months after publication of the primary results, with no end date
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
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