Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke - Full Text View

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:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Transient Ischemic Attack

U.S. FDA Resources

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:

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.

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

Show 55 Study Locations

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:

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.

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

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.


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:


Ischemic Attack, Transient Brain Diseases Brain Ischemia Cardiovascular Diseases	Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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