"Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)"
NCT ID: NCT01025947
Last Updated: 2010-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2009-03-31
2013-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study group
Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
85 Years
ALL
No
Sponsors
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Hospital Universitario Virgen de la Arrixaca
OTHER
Universidad de Murcia
OTHER
University of Valencia
OTHER
Responsible Party
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Hospital Clínico Universitario de Valencia
Principal Investigators
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Ricardo Ruiz-Granell, MD, Phd
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico Universitario de Valencia
Arcadio Garcia-Alberola, MD, PhD
Role: STUDY_CHAIR
Hospital Universitario Virgen de la Arrixaca
Ana Morales, MD
Role: STUDY_CHAIR
Hospital Universitario Virgen de la Arrixaca
Alejandro Ponz, MD
Role: STUDY_CHAIR
Hospital Clinico Universitario de Valencia
Locations
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Hospital Universitario Virgen de la Arrixaca
Murcia, Murcia, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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HCUV
Identifier Type: -
Identifier Source: org_study_id
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