"Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)" (CRYPTONITE)
25. juni 2010 opdateret af: University of Valencia
Observational Study on Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder
STUDY TYPE:
Prospective, national , multicenter, and observational study.
OBJECTIVE:
To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years.
DEVICE:
Reveal XT 9529 (SQDM)
SAMPLE SIZE AND STUDY DURATION:
100 patients enrolled which will be followed during a period of 2 years.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Observational study in patients with cryptogenic stroke (TOAST criteria) and with an implanted EKG loop recorder, with the primary objective of knowing the atrial fibrillation incidence in this population
Undersøgelsestype
Observationel
Tilmelding (Forventet)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Murcia, Spanien, 30120
- Rekruttering
- Hospital Universitario Virgen de la Arrixaca
-
Ledende efterforsker:
- Arcadio García-Alberola, MD, PhD
-
Ledende efterforsker:
- Ana Morales, MD
-
Valencia, Spanien, 46010
- Rekruttering
- Hospital Clinico Universitario de Valencia
-
Ledende efterforsker:
- Ricardo Ruiz-Granell, MD, PhD
-
Ledende efterforsker:
- Alejandro Ponz, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted for detection of atrial fibrillation
Beskrivelse
Inclusion Criteria:
All patients included must meet one of these two conditions:
- Patient presenting with an episode of transient ischemic attack (TIA) of cryptogenic origin with neurological symptoms of less than 24h of evolution and negative neuroimaging.
- First episode of ischaemic stroke with cryptogenic etiology following TOAST criteria
All patients must meet all of the following:
- The patient has been implanted an ILR within 30 days after qualifying event
- Age between 45-85 years
- No stenosis >50% in any arterial vessel corresponding to the affected territory
- Normal Echocardiography
- Normal 24 hours EKG Holter recording
- Absence of Patent Foramen Ovale through transcranial doppler (or transesophageal echocardiography)
- Acceptance and signature of Patient Informed Consent.
Exclusion Criteria:
All patients included cannot meet any of the following conditions:
- Recurrent stroke or TIA
- Stroke or TIA with determined etiology according to TOAST criteria.
- Anticoagulation indication at the time of enrollment in the study.
- Total contraindication for anticoagulation therapy
- Atrial fibrillation detection prior to enrollment
- Severe cognitive impairment or dementia
- Patient unable to be followed up
- Patients enrolled in another clinical trial
- Patients with life expectancy of less than 1 year
- Pregnancy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Study group
Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes.
Tidsramme: Patients will be followed up during two years, regardless of reaching or not the primary endpoint.
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Patients will be followed up during two years, regardless of reaching or not the primary endpoint.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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All subsequent AF episodes detected by the ILR after primary outcome (AF burden)
Tidsramme: Patients will be followed up during two years
|
Patients will be followed up during two years
|
|
AF episodes detected by external monitoring
Tidsramme: Patients will be followed up during two years
|
Patients will be followed up during two years
|
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Presence of stroke, recurrent TIA, or silent infarction in neuroimaging
Tidsramme: Patients will be followed up during two years
|
Patients will be followed up during two years
|
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Changes in anticoagulant therapy
Tidsramme: Patients will be followed up during two years
|
Patients will be followed up during two years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ricardo Ruiz-Granell, MD, Phd, Hospital Clinico Universitario de Valencia
- Studiestol: Arcadio Garcia-Alberola, MD, PhD, Hospital Universitario Virgen de la Arrixaca
- Studiestol: Ana Morales, MD, Hospital Universitario Virgen de la Arrixaca
- Studiestol: Alejandro Ponz, MD, Hospital Clinico Universitario de Valencia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Carandang R, Seshadri S, Beiser A, Kelly-Hayes M, Kase CS, Kannel WB, Wolf PA. Trends in incidence, lifetime risk, severity, and 30-day mortality of stroke over the past 50 years. JAMA. 2006 Dec 27;296(24):2939-46. doi: 10.1001/jama.296.24.2939.
- Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35.
- Solano A, Menozzi C, Maggi R, Donateo P, Bottoni N, Lolli G, Tomasi C, Croci F, Oddone D, Puggioni E, Brignole M. Incidence, diagnostic yield and safety of the implantable loop-recorder to detect the mechanism of syncope in patients with and without structural heart disease. Eur Heart J. 2004 Jul;25(13):1116-9. doi: 10.1016/j.ehj.2004.05.013.
- Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007 Feb 6;115(5):e69-171. doi: 10.1161/CIRCULATIONAHA.106.179918. Epub 2006 Dec 28. No abstract available. Erratum In: Circulation. 2007 Feb 6;115(5):e172. Circulation. 2010 Jul 6;122(1):e9. Kissela, Bret [corrected to Kissela, Brett].
- Jabaudon D, Sztajzel J, Sievert K, Landis T, Sztajzel R. Usefulness of ambulatory 7-day ECG monitoring for the detection of atrial fibrillation and flutter after acute stroke and transient ischemic attack. Stroke. 2004 Jul;35(7):1647-51. doi: 10.1161/01.STR.0000131269.69502.d9. Epub 2004 May 20.
- Adams HP Jr, Davis PH, Leira EC, Chang KC, Bendixen BH, Clarke WR, Woolson RF, Hansen MD. Baseline NIH Stroke Scale score strongly predicts outcome after stroke: A report of the Trial of Org 10172 in Acute Stroke Treatment (TOAST). Neurology. 1999 Jul 13;53(1):126-31. doi: 10.1212/wnl.53.1.126.
- Sacco RL, Ellenberg JH, Mohr JP, Tatemichi TK, Hier DB, Price TR, Wolf PA. Infarcts of undetermined cause: the NINCDS Stroke Data Bank. Ann Neurol. 1989 Apr;25(4):382-90. doi: 10.1002/ana.410250410.
- Douen AG, Pageau N, Medic S. Serial electrocardiographic assessments significantly improve detection of atrial fibrillation 2.6-fold in patients with acute stroke. Stroke. 2008 Feb;39(2):480-2. doi: 10.1161/STROKEAHA.107.492595. Epub 2008 Jan 3.
- Liao J, Khalid Z, Scallan C, Morillo C, O'Donnell M. Noninvasive cardiac monitoring for detecting paroxysmal atrial fibrillation or flutter after acute ischemic stroke: a systematic review. Stroke. 2007 Nov;38(11):2935-40. doi: 10.1161/STROKEAHA.106.478685. Epub 2007 Sep 27.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2009
Primær færdiggørelse (Forventet)
1. marts 2013
Studieafslutning (Forventet)
1. marts 2013
Datoer for studieregistrering
Først indsendt
3. december 2009
Først indsendt, der opfyldte QC-kriterier
3. december 2009
Først opslået (Skøn)
4. december 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. juni 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2010
Sidst verificeret
1. juni 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HCUV
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 .