Clinical trial NCT00924638: Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
Official title: CRYptogenic STroke And underLying AF Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cryptogenic Symptomatic Transient Ischemic Attack
Cryptogenic Ischemic Stroke
Keywords: atrial fibrillation
cryptogenic stroke
continuous monitoring
implantable loop recorder
insertable cardiac monitor
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 447
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: AF Detection Rate Within 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: AF Detection Rate Within 12 Months
timeFrame: 12 months
measure: Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)
timeFrame: 12 months
measure: Use of Oral Anticoagulation (OAC) Drugs
timeFrame: 12 months
measure: Use of Antiarrhythmic Drugs
timeFrame: 12 months
measure: Health Outcome as Evaluated by EQ-5D Questionnaire
timeFrame: 12 months
measure: Clinical Disease Burden and Care Pathway
timeFrame: 12 months
measure: Impact of Patient Assistant Use on AF Diagnosis
timeFrame: Follow-up closure
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Denver
country: United States
facility: South Denver Cardiology / Swedish Medical Center
state: Colorado
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Des Moines
country: United States
facility: Iowa Heart / Ruan Neurology
state: Iowa
city: Louisville
country: United States
facility: Louisville Cardiology
state: Kentucky
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC
state: Mississippi
city: Kansas City
country: United States
facility: Mid America Heart Institute / St. Lukes Hospital
state: Missouri
city: St. Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio Health Research
state: Ohio
city: Eugene
country: United States
facility: Sacred Heart Medical Center
state: Oregon
city: Doylestown
country: United States
facility: Central Bucks Specialists / Doylestown Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System Cardiology/Cardiovascular Research
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Dallas
country: United States
facility: University of Texas - Southwestern Medical Center
state: Texas
city: Graz
country: Austria
facility: LKH Universitätsklinikum Graz
city: Linz
country: Austria
facility: AKH Linz
city: Tulln
country: Austria
facility: Landesklinikum Donauregion Tulln
city: Antwerp
country: Belgium
facility: UZ Antwerpen
city: Brussels
country: Belgium
facility: Brussels Heart Center (St. Lean - St. Pierre)
city: Leuven
country: Belgium
facility: UZ Leuven
city: Mont Godinne
country: Belgium
facility: Cliniques Universitaires UCL Mont-Godinne
city: Hamilton
country: Canada
facility: Hamilton Health Sciences / Hamilton General Hospital
state: Ontario
city: Sherbrooke
country: Canada
facility: CHUS / Hopital Fleurimont
state: Quebec
city: Aarhus
country: Denmark
facility: Skejby Hospital
city: Turku
country: Finland
facility: Neurology clinic, Turku University Central Hospital
city: Bordeaux
country: France
facility: Hôpital Saint André -CHU de Bordeaux
city: Le Chesnay
country: France
facility: Clinique Parly II - Centre Hospitalier de Versailles
city: Marseille
country: France
facility: Hôpital de la Timone
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
state: Bayern
city: Bochum
country: Germany
facility: Knappschaftskrankenhaus Bochum
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Goettingen
country: Germany
facility: UMG, Goettingen
city: Greifswald
country: Germany
facility: Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald
city: Hamburg
country: Germany
facility: Asklepios Altona
city: Hamburg
country: Germany
facility: Asklepios Barmbek
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe GmbH
city: Rastatt
country: Germany
facility: Kreiskrankenhaus Rastatt
city: Athens
country: Greece
facility: Henry Dunant General Hospital
city: Grosseto
country: Italy
facility: Ospedale Misericordia di Grosseto
city: Imperia
country: Italy
facility: Ospedale di Imperia
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Seriate
country: Italy
facility: Ospedale Bolognini
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Bratislava
country: Slovakia
facility: NUSCH, a.s. Bratislava
city: Kosice
country: Slovakia
facility: VUSCH Kosice
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
city: Lund
country: Sweden
facility: University Hospital Lund
Study officials:
affiliation: Klinikum Coburg, Germany
name: Johannes Brachmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University, Italy
name: Tommaso Sanna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Neurologie, Essen, Germany
name: Hans Christoph Diener, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster Clinic, Hamilton, Ontario, Canada
name: Carlos Morillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Davee Department of Neurology, Chicago, IL USA
name: Richard Bernstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University Rome, Rome Italy
name: Vincenzo Di Lazzaro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern Memorial Hospital, Chicago, IL USA
name: Rod Passman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Lukes Hospital of Kansas City, Kansas City, MI USA
name: Marilyn Rymer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1161/01.STR.0000199147.30016.74.
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.
citation: Kaffenberger T, Bernhardt J, Koehler JL, Ziegler PD, Thijs VN. Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study. Ann Phys Rehabil Med. 2022 Mar;65(2):101540. doi: 10.1016/j.rehab.2021.101540. Epub 2021 Nov 13.
citation: Witte KK, Tsivgoulis G, Reynolds MR, Tsintzos SI, Eggington S, Ismyrloglou E, Lyon J, Huynh M, Egea M, de Brouwer B, Ziegler PD, Franco N, Joglekar R, Rosemas SC, Liu S, Thijs V. Burden of oral anticoagulation in embolic stroke of undetermined source without atrial fibrillation. BMC Cardiovasc Disord. 2021 Mar 31;21(1):160. doi: 10.1186/s12872-021-01967-x.
citation: Verma N, Ziegler PD, Liu S, Passman RS. Incidence of atrial fibrillation among patients with an embolic stroke of undetermined source: Insights from insertable cardiac monitors. Int J Stroke. 2019 Feb;14(2):146-153. doi: 10.1177/1747493018798554. Epub 2018 Sep 10.
citation: Brachmann J, Morillo CA, Sanna T, Di Lazzaro V, Diener HC, Bernstein RA, Rymer M, Ziegler PD, Liu S, Passman RS. Uncovering Atrial Fibrillation Beyond Short-Term Monitoring in Cryptogenic Stroke Patients: Three-Year Results From the Cryptogenic Stroke and Underlying Atrial Fibrillation Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003333. doi: 10.1161/CIRCEP.115.003333.
citation: Bernstein RA, Di Lazzaro V, Rymer MM, Passman RS, Brachmann J, Morillo CA, Sanna T, Thijs V, Rogers T, Liu S, Ziegler PD, Diener HC. Infarct Topography and Detection of Atrial Fibrillation in Cryptogenic Stroke: Results from CRYSTAL AF. Cerebrovasc Dis. 2015;40(1-2):91-6. doi: 10.1159/000437018. Epub 2015 Jul 11.
citation: 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.