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

This study has been completed.
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00924638
First received: June 17, 2009
Last updated: January 9, 2014
Last verified: January 2014

June 17, 2009
January 9, 2014
June 2009
May 2013   (final data collection date for primary outcome measure)
Time to first documented episode of AF [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00924638 on ClinicalTrials.gov Archive Site
  • Time to first documented episode of AF [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of stroke and Transient Ischemic Attack (TIA) [ Time Frame: Follow-up Closure ] [ Designated as safety issue: No ]
  • Cardiovascular drug changes [ Time Frame: Follow-up closure ] [ Designated as safety issue: No ]
  • Health outcome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Clinical disease burden and care pathway [ Time Frame: Follow-up closure ] [ Designated as safety issue: No ]
  • Patient Assistant impact on AF diagnosis [ Time Frame: Follow-up closure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
CRYptogenic STroke And underLying AF Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Cryptogenic Symptomatic Transient Ischemic Attack
  • Cryptogenic Ischemic Stroke
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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
448
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   Denmark,   Finland,   France,   Germany,   Greece,   Italy,   Netherlands,   Slovakia,   Spain,   Sweden
 
NCT00924638
CRYSTAL-AF
Yes
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
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
Medtronic Cardiac Rhythm Disease Management
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP