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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00924638
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease Intervention/treatment Phase
Cryptogenic Symptomatic Transient Ischemic Attack Cryptogenic Ischemic Stroke Device: Reveal® XT Insertable Cardiac Monitor Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 447 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CRYptogenic STroke And underLying AF Trial
Study Start Date : June 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Continuous Monitoring
Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
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
No Intervention: Control Arm
Follow-up at the same frequency, but with no Insertable Cardiac Monitor

Primary Outcome Measures :
  1. AF Detection Rate Within 6 Months [ Time Frame: 6 months ]
    Percentage of subjects with AF detected within 6 months of follow-up

Secondary Outcome Measures :
  1. AF Detection Rate Within 12 Months [ Time Frame: 12 months ]
    Percentage of subjects with AF detected within 12 months of follow-up

  2. 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

  3. 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

  4. Use of Antiarrhythmic Drugs [ Time Frame: 12 months ]
    Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit

  5. 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).

  6. Clinical Disease Burden and Care Pathway [ Time Frame: 12 months ]
    Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months

  7. 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

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.

Exclusion Criteria:

  1. Known etiology of TIA or stroke.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00924638

  Hide Study Locations
United States, California
El Camino Hospital
Mountain View, California, United States
United States, Colorado
South Denver Cardiology / Swedish Medical Center
Denver, Colorado, United States
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States
United States, Iowa
Iowa Heart / Ruan Neurology
Des Moines, Iowa, United States
United States, Kentucky
Louisville Cardiology
Louisville, Kentucky, United States
United States, Mississippi
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
United States, Missouri
Mid America Heart Institute / St. Lukes Hospital
Kansas City, Missouri, United States
Washington University Medical School
St. Louis, Missouri, United States
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States
United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States
United States, Ohio
Ohio Health Research
Columbus, Ohio, United States
United States, Oregon
Sacred Heart Medical Center
Eugene, Oregon, United States
United States, Pennsylvania
Central Bucks Specialists / Doylestown Hospital
Doylestown, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
United States, South Carolina
Greenville Hospital System Cardiology/Cardiovascular Research
Greenville, South Carolina, United States
United States, Tennessee
St. Thomas Research Institute
Nashville, Tennessee, United States
United States, Texas
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
Canada, Ontario
Hamilton Health Sciences / Hamilton General Hospital
Hamilton, Ontario, Canada
Canada, Quebec
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, Bayern, Germany
Knappschaftskrankenhaus Bochum
Bochum, Germany
Klinikum Dortmund
Dortmund, Germany
Universitätsklinikum Essen
Essen, Germany
UMG, Goettingen
Goettingen, 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
Kosice, Slovakia
Hospital Puerta de Hierro Majadahonda
Majadahonda, Spain
University Hospital Lund
Lund, Sweden
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Medtronic Bakken Research Center
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure Identifier: NCT00924638     History of Changes
Other Study ID Numbers: CRYSTAL-AF
First Posted: June 19, 2009    Key Record Dates
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014
Last Verified: January 2014

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
atrial fibrillation
cryptogenic stroke
continuous monitoring
implantable loop recorder
insertable cardiac monitor

Additional relevant MeSH terms:
Atrial Fibrillation
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Brain Ischemia