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Responsible party does not work at UV anymore
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| Name | Class |
|---|---|
| Hospital ClÃnico Universitario de Valencia | OTHER |
| Hospital Universitario Virgen de la Arrixaca | OTHER |
| Universidad de Murcia | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Patients will be followed up during two years, regardless of reaching or not the primary endpoint. |
| Measure | Description | Time Frame |
|---|---|---|
| All subsequent AF episodes detected by the ILR after primary outcome (AF burden) | Patients will be followed up during two years | |
| AF episodes detected by external monitoring | Patients will be followed up during two years |
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Inclusion Criteria:
All patients included must meet one of these two conditions:
All patients must meet all of the following:
Exclusion Criteria:
All patients included cannot meet any of the following conditions:
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Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted for detection of atrial fibrillation
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Ruiz-Granell, MD, Phd | Hospital Clinico Universitario de Valencia | Principal Investigator |
| Arcadio Garcia-Alberola, MD, PhD | Hospital Universitario Virgen de la Arrixaca | Study Chair |
| Ana Morales, MD | Hospital Universitario Virgen de la Arrixaca | Study Chair |
| Alejandro Ponz, MD | Hospital Clinico Universitario de Valencia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de la Arrixaca | Murcia | 30120 | Spain | |||
| Hospital Clinico Universitario de Valencia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17194875 | Background | 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. | |
| 17190894 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Presence of stroke, recurrent TIA, or silent infarction in neuroimaging | Patients will be followed up during two years |
| Changes in anticoagulant therapy | Patients will be followed up during two years |
| Valencia |
| 46010 |
| Spain |
| Background |
| 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. |
| 7678184 | Background | 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. |
| 10408548 | Background | 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. |
| 2712533 | Background | 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. |
| 15155965 | Background | 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. |
| 18174488 | Background | 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. |
| 17901394 | Background | 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. |
| 15231369 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |