Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
NCT ID: NCT00924638
Last Updated: 2014-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
447 participants
INTERVENTIONAL
2009-06-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Continuous Monitoring
Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor
The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
Control Arm
Follow-up at the same frequency, but with no Insertable Cardiac Monitor
No interventions assigned to this group
Interventions
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Reveal® XT Insertable Cardiac Monitor
The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Untreated hyperthyroidism.
3. Myocardial infarction less than 1 month prior to stroke or TIA.
4. Coronary bypass grafting less than 1 month prior to stroke or TIA.
5. Valvular disease requiring immediate surgical intervention.
6. History of AF or atrial flutter.
7. Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral anticoagulation (OAC).
8. Permanent indication for OAC at enrollment.
9. Permanent contra-indication for OAC.
10. Included in another clinical trial.
11. Life expectancy less than 1 year.
12. Pregnant.
13. Indicated for Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system.
14. Not fit, unable or unwilling to follow the required procedures of the protocol.
40 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Johannes Brachmann, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Coburg, Germany
Tommaso Sanna, MD
Role: PRINCIPAL_INVESTIGATOR
Catholic University, Italy
Hans Christoph Diener, MD
Role: PRINCIPAL_INVESTIGATOR
Klinik für Neurologie, Essen, Germany
Carlos Morillo, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster Clinic, Hamilton, Ontario, Canada
Richard Bernstein, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Davee Department of Neurology, Chicago, IL USA
Vincenzo Di Lazzaro, MD
Role: PRINCIPAL_INVESTIGATOR
Catholic University Rome, Rome Italy
Rod Passman, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Memorial Hospital, Chicago, IL USA
Marilyn Rymer, MD
Role: PRINCIPAL_INVESTIGATOR
St. Lukes Hospital of Kansas City, Kansas City, MI USA
Locations
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El Camino Hospital
Mountain View, California, United States
South Denver Cardiology / Swedish Medical Center
Denver, Colorado, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Iowa Heart / Ruan Neurology
Des Moines, Iowa, United States
Louisville Cardiology
Louisville, Kentucky, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
Mid America Heart Institute / St. Lukes Hospital
Kansas City, Missouri, United States
Washington University Medical School
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Ohio Health Research
Columbus, Ohio, United States
Sacred Heart Medical Center
Eugene, Oregon, United States
Central Bucks Specialists / Doylestown Hospital
Doylestown, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Lankenau
Wynnewood, Pennsylvania, United States
Greenville Hospital System Cardiology/Cardiovascular Research
Greenville, South Carolina, United States
St. Thomas Research Institute
Nashville, Tennessee, United States
Baylor Research Institute
Dallas, Texas, United States
University of Texas - Southwestern Medical Center
Dallas, Texas, United States
LKH Universitätsklinikum Graz
Graz, , Austria
AKH Linz
Linz, , Austria
Landesklinikum Donauregion Tulln
Tulln, , Austria
UZ Antwerpen
Antwerp, , Belgium
Brussels Heart Center (St. Lean - St. Pierre)
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Cliniques Universitaires UCL Mont-Godinne
Mont Godinne, , Belgium
Hamilton Health Sciences / Hamilton General Hospital
Hamilton, Ontario, Canada
CHUS / Hopital Fleurimont
Sherbrooke, Quebec, Canada
Skejby Hospital
Aarhus, , Denmark
Neurology clinic, Turku University Central Hospital
Turku, , Finland
Hôpital Saint André -CHU de Bordeaux
Bordeaux, , France
Clinique Parly II - Centre Hospitalier de Versailles
Le Chesnay, , France
Hôpital de la Timone
Marseille, , France
Klinikum Coburg GmbH
Coburg, Bavaria, Germany
Knappschaftskrankenhaus Bochum
Bochum, , Germany
Klinikum Dortmund
Dortmund, , Germany
Universitätsklinikum Essen
Essen, , Germany
UMG, Goettingen
Göttingen, , Germany
Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, , Germany
Asklepios Altona
Hamburg, , Germany
Asklepios Barmbek
Hamburg, , Germany
Städtisches Klinikum Karlsruhe GmbH
Karlsruhe, , Germany
Kreiskrankenhaus Rastatt
Rastatt, , Germany
Henry Dunant General Hospital
Athens, , Greece
Ospedale Misericordia di Grosseto
Grosseto, , Italy
Ospedale di Imperia
Imperia, , Italy
Policlinico Universitario Agostino Gemelli
Rome, , Italy
Ospedale Bolognini
Seriate, , Italy
Atrium Medisch Centrum
Heerlen, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
NUSCH, a.s. Bratislava
Bratislava, , Slovakia
VUSCH Kosice
Košice, , Slovakia
Hospital Puerta de Hierro Majadahonda
Majadahonda, , Spain
University Hospital Lund
Lund, , Sweden
Countries
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References
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Sacco RL, Adams R, Albers G, Alberts MJ, Benavente O, Furie K, Goldstein LB, Gorelick P, Halperin J, Harbaugh R, Johnston SC, Katzan I, Kelly-Hayes M, Kenton EJ, Marks M, Schwamm LH, Tomsick T; American Heart Association; American Stroke Association Council on Stroke; Council on Cardiovascular Radiology and Intervention; American Academy of Neurology. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention: the American Academy of Neurology affirms the value of this guideline. Stroke. 2006 Feb;37(2):577-617. doi: 10.1161/01.STR.0000199147.30016.74.
Sinha AM, Diener HC, Morillo CA, Sanna T, Bernstein RA, Di Lazzaro V, Passman R, Beckers F, Brachmann J. Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL AF): design and rationale. Am Heart J. 2010 Jul;160(1):36-41.e1. doi: 10.1016/j.ahj.2010.03.032.
Kaffenberger T, Bernhardt J, Koehler JL, Ziegler PD, Thijs VN. Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study. Ann Phys Rehabil Med. 2022 Mar;65(2):101540. doi: 10.1016/j.rehab.2021.101540. Epub 2021 Nov 13.
Witte KK, Tsivgoulis G, Reynolds MR, Tsintzos SI, Eggington S, Ismyrloglou E, Lyon J, Huynh M, Egea M, de Brouwer B, Ziegler PD, Franco N, Joglekar R, Rosemas SC, Liu S, Thijs V. Burden of oral anticoagulation in embolic stroke of undetermined source without atrial fibrillation. BMC Cardiovasc Disord. 2021 Mar 31;21(1):160. doi: 10.1186/s12872-021-01967-x.
Verma N, Ziegler PD, Liu S, Passman RS. Incidence of atrial fibrillation among patients with an embolic stroke of undetermined source: Insights from insertable cardiac monitors. Int J Stroke. 2019 Feb;14(2):146-153. doi: 10.1177/1747493018798554. Epub 2018 Sep 10.
Brachmann J, Morillo CA, Sanna T, Di Lazzaro V, Diener HC, Bernstein RA, Rymer M, Ziegler PD, Liu S, Passman RS. Uncovering Atrial Fibrillation Beyond Short-Term Monitoring in Cryptogenic Stroke Patients: Three-Year Results From the Cryptogenic Stroke and Underlying Atrial Fibrillation Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003333. doi: 10.1161/CIRCEP.115.003333.
Bernstein RA, Di Lazzaro V, Rymer MM, Passman RS, Brachmann J, Morillo CA, Sanna T, Thijs V, Rogers T, Liu S, Ziegler PD, Diener HC. Infarct Topography and Detection of Atrial Fibrillation in Cryptogenic Stroke: Results from CRYSTAL AF. Cerebrovasc Dis. 2015;40(1-2):91-6. doi: 10.1159/000437018. Epub 2015 Jul 11.
Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.
Other Identifiers
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CRYSTAL-AF
Identifier Type: -
Identifier Source: org_study_id
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