[Prøvning af enhed, der ikke er godkendt eller godkendt af 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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Daegu, Sydkorea
- Daegu Catholic University Medical Center
-
Seoul, Sydkorea, 02447
- Kyung Hee University Hospital
-
Seoul, Sydkorea, 06273
- Yonsei University Health System, Severance Hospital
-
-
Seoul
-
Gangseo, Seoul, Sydkorea, 07985
- Ewha Womans University Seoul Hospital
-
Seongdong, Seoul, Sydkorea, 04763
- Hanyang University Seoul Hospital
-
Seoul, Seoul, Sydkorea, 08308
- Korea University Guro Hospital
-
Yangcheon, Seoul, Sydkorea, 07985
- Ewha Womans University Mokdong Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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 navne:
|
|
Eksperimentel: 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 navne:
Twice-daily 30-second handheld single-lead ECG recording for 12 months.
Andre navne:
|
|
Eksperimentel: 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 navne:
72-hour continuous single-lead patch ECG monitoring at 1, 3, 6, and 12 months (four sessions)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrent ischemic stroke or transient ischemic attack
Tidsramme: Within 12 months after randomization
|
Within 12 months after randomization
|
|
|
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
|
|
All-cause readmission
Tidsramme: Within 12 months after randomization
|
Within 12 months after randomization
|
|
|
All-cause death
Tidsramme: Within 12 months after randomization
|
All-cause death |
Within 12 months after randomization
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Junbeom Park, M.D., PhD., Ewha Womans University Mokdong Hospital
- Ledende efterforsker: Tae-Jin Song, MD, Ewha Womans University Seoul Hospital
- Ledende efterforsker: Dong-Hyeok Kim, MD, Ewha Womans University Seoul Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Karsygdomme
- Hjerte-kar-sygdomme
- Patologiske processer
- Hjertesygdomme
- Arytmier, hjerte
- Hjerneiskæmi
- Slag
- Patologiske tilstande, tegn og symptomer
- Iskæmisk slagtilfælde
- Iskæmisk angreb, forbigående
- Atrieflimren
- Diagnostiske teknikker og procedurer
- Diagnose
- Diagnostiske teknikker, kardiovaskulær
- Hjertefunktionstest
- Elektrodiagnose
- Overvågning, fysiologisk
- Elektrokardiografi
- Overvågning, ambulant
- Elektrokardiografi, ambulant
Andre undersøgelses-id-numre
- CANDLE-AF Trial
- NRF-2022R1A2C1093352 (Andet bevillings-/finansieringsnummer: National Research Foundation of Korea)
- RS-2020-KD000234 (Andet bevillings-/finansieringsnummer: Korea Medical Device Development Fund)
- RS-2025-25459963 (Andet bevillings-/finansieringsnummer: Korea Health Industry Development Institute)
- KCT0005592 (Registry Identifier: CRIS)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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
IPD-delingsadgangskriterier
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 Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .