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: June 26, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Cryptogenic Symptomatic Transient Ischemic Attack
Cryptogenic Ischemic Stroke
Device: Reveal® XT Insertable Cardiac Monitor
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: CRYptogenic STroke And underLying AF Trial

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • AF Detection Rate Within 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage of subjects with AF detected within 6 months of follow-up


Secondary Outcome Measures:
  • AF Detection Rate Within 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up

  • Use of Oral Anticoagulation (OAC) Drugs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of subjects who were using OAC drugs at the 12 months follow-up visit

  • Use of Antiarrhythmic Drugs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency


Enrollment: 447
Study Start Date: June 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924638

  Hide Study Locations
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
Lankenau
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
Austria
LKH Universitätsklinikum Graz
Graz, Austria
AKH Linz
Linz, Austria
Landesklinikum Donauregion Tulln
Tulln, Austria
Belgium
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
Denmark
Skejby Hospital
Aarhus, Denmark
Finland
Neurology clinic, Turku University Central Hospital
Turku, Finland
France
Hôpital Saint André -CHU de Bordeaux
Bordeaux, France
Clinique Parly II - Centre Hospitalier de Versailles
Le Chesnay, France
Hôpital de la Timone
Marseille, France
Germany
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 Barmbek
Hamburg, Germany
Asklepios Altona
Hamburg, Germany
Städtisches Klinikum Karlsruhe GmbH
Karlsruhe, Germany
Kreiskrankenhaus Rastatt
Rastatt, Germany
Greece
Henry Dunant General Hospital
Athens, Greece
Italy
Ospedale Misericordia di Grosseto
Grosseto, Italy
Ospedale di Imperia
Imperia, Italy
Policlinico Universitario Agostino Gemelli
Rome, Italy
Ospedale Bolognini
Seriate, Italy
Netherlands
Atrium Medisch Centrum
Heerlen, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
UMC Utrecht
Utrecht, Netherlands
Slovakia
NUSCH, a.s. Bratislava
Bratislava, Slovakia
VUSCH Kosice
Kosice, Slovakia
Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, Spain
Sweden
University Hospital Lund
Lund, Sweden
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Medtronic Bakken Research Center
Investigators
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00924638     History of Changes
Other Study ID Numbers: CRYSTAL-AF
Study First Received: June 17, 2009
Results First Received: June 26, 2014
Last Updated: June 26, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
atrial fibrillation
cryptogenic stroke
continuous monitoring
implantable loop recorder
insertable cardiac monitor

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

ClinicalTrials.gov processed this record on July 26, 2014