Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke

Cryptogenic Ischemic Stroke Clinical Trial

— CRYSTAL-AF  

Official title:

CRYptogenic STroke And underLying AF Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924638
• Other study ID #: CRYSTAL-AF
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2009
• Last updated: June 26, 2014
• Start date: June 2009
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cryptogenic Ischemic Stroke
• Cryptogenic Symptomatic Transient Ischemic Attack
• Ischemia
• Ischemic Attack, Transient
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Austria	LKH Universitätsklinikum Graz	Graz
Austria	AKH Linz	Linz
Austria	Landesklinikum Donauregion Tulln	Tulln
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
Canada	Hamilton Health Sciences / Hamilton General Hospital	Hamilton	Ontario
Canada	CHUS / Hopital Fleurimont	Sherbrooke	Quebec
Denmark	Skejby Hospital	Aarhus
Finland	Neurology clinic, Turku University Central Hospital	Turku
France	Hôpital Saint André -CHU de Bordeaux	Bordeaux
France	Clinique Parly II - Centre Hospitalier de Versailles	Le Chesnay
France	Hôpital de la Timone	Marseille
Germany	Knappschaftskrankenhaus Bochum	Bochum
Germany	Klinikum Coburg GmbH	Coburg	Bayern
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
Greece	Henry Dunant General Hospital	Athens
Italy	Ospedale Misericordia di Grosseto	Grosseto
Italy	Ospedale di Imperia	Imperia
Italy	Policlinico Universitario Agostino Gemelli	Rome
Italy	Ospedale Bolognini	Seriate
Netherlands	Atrium Medisch Centrum	Heerlen
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	UMC Utrecht	Utrecht
Slovakia	NUSCH, a.s. Bratislava	Bratislava
Slovakia	VUSCH Kosice	Kosice
Spain	Hospital Puerta de Hierro Majadahonda	Majadahonda
Sweden	University Hospital Lund	Lund
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Ohio Health Research	Columbus	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	University of Texas - Southwestern Medical Center	Dallas	Texas
United States	South Denver Cardiology / Swedish Medical Center	Denver	Colorado
United States	Iowa Heart / Ruan Neurology	Des Moines	Iowa
United States	Central Bucks Specialists / Doylestown Hospital	Doylestown	Pennsylvania
United States	Sacred Heart Medical Center	Eugene	Oregon
United States	Greenville Hospital System Cardiology/Cardiovascular Research	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Mid America Heart Institute / St. Lukes Hospital	Kansas City	Missouri
United States	Louisville Cardiology	Louisville	Kentucky
United States	El Camino Hospital	Mountain View	California
United States	St. Thomas Research Institute	Nashville	Tennessee
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Washington University Medical School	St. Louis	Missouri
United States	Cardiology Associates Research, LLC	Tupelo	Mississippi
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Lankenau	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management	Medtronic Bakken Research Center

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Greece,  Italy,  Netherlands,  Slovakia,  Spain,  Sweden, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF Detection Rate Within 6 Months	Percentage of subjects with AF detected within 6 months of follow-up	6 months	No
Secondary	AF Detection Rate Within 12 Months	Percentage of subjects with AF detected within 12 months of follow-up	12 months	No
Secondary	Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)	Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up	12 months	No
Secondary	Use of Oral Anticoagulation (OAC) Drugs	Percentage of subjects who were using OAC drugs at the 12 months follow-up visit	12 months	No
Secondary	Use of Antiarrhythmic Drugs	Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit	12 months	No
Secondary	Health Outcome as Evaluated by EQ-5D Questionnaire	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).	12 months	No
Secondary	Clinical Disease Burden and Care Pathway	Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months	12 months	No
Secondary	Impact of Patient Assistant Use on AF Diagnosis	AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency	Follow-up closure	No