Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke (CRYSTAL-AF)

Tracking Information
First Submitted Date ICMJE	June 17, 2009
First Posted Date ICMJE	June 19, 2009
Results First Submitted Date	June 26, 2014
Results First Posted Date	July 28, 2014
Last Update Posted Date	July 28, 2014
Study Start Date ICMJE	June 2009
Actual Primary Completion Date	May 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 26, 2014)	AF Detection Rate Within 6 Months [ Time Frame: 6 months ]; Percentage of subjects with AF detected within 6 months of follow-up
Original Primary Outcome Measures ICMJE; (submitted: June 18, 2009)	Time to first documented episode of AF [ Time Frame: 6 months ]
Change History	Complete list of historical versions of study NCT00924638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 26, 2014)	AF Detection Rate Within 12 Months [ Time Frame: 12 months ]Percentage of subjects with AF detected within 12 months of follow-up; Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack) [ Time Frame: 12 months ]Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up; Use of Oral Anticoagulation (OAC) Drugs [ Time Frame: 12 months ]Percentage of subjects who were using OAC drugs at the 12 months follow-up visit; Use of Antiarrhythmic Drugs [ Time Frame: 12 months ]Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit; Health Outcome as Evaluated by EQ-5D Questionnaire [ Time Frame: 12 months ]EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health).; Clinical Disease Burden and Care Pathway [ Time Frame: 12 months ]Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months; Impact of Patient Assistant Use on AF Diagnosis [ Time Frame: Follow-up closure ]AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency
Original Secondary Outcome Measures ICMJE; (submitted: June 18, 2009)	Time to first documented episode of AF [ Time Frame: 12 months ]; Incidence of stroke and Transient Ischemic Attack (TIA) [ Time Frame: Follow-up Closure ]; Cardiovascular drug changes [ Time Frame: Follow-up closure ]; Health outcome [ Time Frame: 12 months ]; Clinical Disease Burden and Care Pathway [ Time Frame: Follow-up closure ]; Patient Assistant impact on AF diagnosis [ Time Frame: Follow-up closure ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
Official Title ICMJE	CRYptogenic STroke And underLying AF Trial
Brief Summary	The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin for stroke prevention. Physicians can best optimize the use of medicines only if they can precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the time to first AF by 6 months' continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history of AF.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Cryptogenic Symptomatic Transient Ischemic Attack; Cryptogenic Ischemic Stroke
Intervention ICMJE	Device: 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 Name: Reveal® XT
Study Arms	Active Comparator: Continuous Monitoring Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Intervention: Device: Reveal® XT Insertable Cardiac Monitor; No Intervention: Control Arm Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Publications *	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.; 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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 26, 2014)	447
Original Estimated Enrollment ICMJE; (submitted: June 18, 2009)	450
Actual Study Completion Date	May 2013
Actual Primary Completion Date	May 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke. Exclusion Criteria: Known etiology of TIA or stroke.; Untreated hyperthyroidism.; Myocardial infarction less than 1 month prior to stroke or TIA.; Coronary bypass grafting less than 1 month prior to stroke or TIA.; Valvular disease requiring immediate surgical intervention.; History of AF or atrial flutter.; Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral anticoagulation (OAC).; Permanent indication for OAC at enrollment.; Permanent contra-indication for OAC.; Included in another clinical trial.; Life expectancy less than 1 year.; Pregnant.; Indicated for Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system.; Not fit, unable or unwilling to follow the required procedures of the protocol.
Sex/Gender	Sexes Eligible for Study: All
Ages	40 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Slovakia, Spain, Sweden, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00924638
Other Study ID Numbers ICMJE	CRYSTAL-AF
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor ICMJE	Medtronic Cardiac Rhythm and Heart Failure
Collaborators ICMJE	Medtronic Bakken Research Center
Investigators ICMJE	Principal Investigator: Johannes Brachmann, MD Klinikum Coburg, Germany Principal Investigator: Tommaso Sanna, MD Catholic University, Italy Principal Investigator: Hans Christoph Diener, MD Klinik für Neurologie, Essen, Germany Principal Investigator: Carlos Morillo, MD McMaster Clinic, Hamilton, Ontario, Canada Principal Investigator: Richard Bernstein, MD, PhD Davee Department of Neurology, Chicago, IL USA Principal Investigator: Vincenzo Di Lazzaro, MD Catholic University Rome, Rome Italy Principal Investigator: Rod Passman, MD Northwestern Memorial Hospital, Chicago, IL USA Principal Investigator: Marilyn Rymer, MD St. Lukes Hospital of Kansas City, Kansas City, MI USA
PRS Account	Medtronic Cardiac Rhythm and Heart Failure
Verification Date	January 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP