Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00924638
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00924638


Locations
Show Show 55 study locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Medtronic Bakken Research Center
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00924638    
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:
Layout table for MeSH terms
Stroke
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia