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

Primary Purpose

Cryptogenic Symptomatic Transient Ischemic Attack, Cryptogenic Ischemic Stroke

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Reveal® XT Insertable Cardiac Monitor
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cryptogenic Symptomatic Transient Ischemic Attack focused on measuring atrial fibrillation, cryptogenic stroke, continuous monitoring, implantable loop recorder, insertable cardiac monitor

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • El Camino Hospital
  • South Denver Cardiology / Swedish Medical Center
  • Northwestern Memorial Hospital
  • Iowa Heart / Ruan Neurology
  • Louisville Cardiology
  • Cardiology Associates Research, LLC
  • Mid America Heart Institute / St. Lukes Hospital
  • Washington University Medical School
  • Hackensack University Medical Center
  • Forsyth Medical Center
  • Ohio Health Research
  • Sacred Heart Medical Center
  • Central Bucks Specialists / Doylestown Hospital
  • Thomas Jefferson University
  • Lankenau
  • Greenville Hospital System Cardiology/Cardiovascular Research
  • St. Thomas Research Institute
  • Baylor Research Institute
  • University of Texas - Southwestern Medical Center
  • LKH Universitätsklinikum Graz
  • AKH Linz
  • Landesklinikum Donauregion Tulln
  • UZ Antwerpen
  • Brussels Heart Center (St. Lean - St. Pierre)
  • UZ Leuven
  • Cliniques Universitaires UCL Mont-Godinne
  • Hamilton Health Sciences / Hamilton General Hospital
  • CHUS / Hopital Fleurimont
  • Skejby Hospital
  • Neurology clinic, Turku University Central Hospital
  • Hôpital Saint André -CHU de Bordeaux
  • Clinique Parly II - Centre Hospitalier de Versailles
  • Hôpital de la Timone
  • Klinikum Coburg GmbH
  • Knappschaftskrankenhaus Bochum
  • Klinikum Dortmund
  • Universitätsklinikum Essen
  • UMG, Goettingen
  • Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald
  • Asklepios Altona
  • Asklepios Barmbek
  • Städtisches Klinikum Karlsruhe GmbH
  • Kreiskrankenhaus Rastatt
  • Henry Dunant General Hospital
  • Ospedale Misericordia di Grosseto
  • Ospedale di Imperia
  • Policlinico Universitario Agostino Gemelli
  • Ospedale Bolognini
  • Atrium Medisch Centrum
  • St. Antonius Ziekenhuis
  • UMC Utrecht
  • NUSCH, a.s. Bratislava
  • VUSCH Kosice
  • Hospital Puerta de Hierro Majadahonda
  • University Hospital Lund

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Continuous Monitoring

Control Arm

Arm Description

Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor

Follow-up at the same frequency, but with no Insertable Cardiac Monitor

Outcomes

Primary Outcome Measures

AF Detection Rate Within 6 Months
Percentage of subjects with AF detected within 6 months of follow-up

Secondary Outcome Measures

AF Detection Rate Within 12 Months
Percentage of subjects with AF detected within 12 months of follow-up
Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)
Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up
Use of Oral Anticoagulation (OAC) Drugs
Percentage of subjects who were using OAC drugs at the 12 months follow-up visit
Use of Antiarrhythmic Drugs
Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit
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).
Clinical Disease Burden and Care Pathway
Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months
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

Full Information

First Posted
June 17, 2009
Last Updated
June 26, 2014
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic Bakken Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00924638
Brief Title
Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
Acronym
CRYSTAL-AF
Official Title
CRYptogenic STroke And underLying AF Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptogenic Symptomatic Transient Ischemic Attack, Cryptogenic Ischemic Stroke
Keywords
atrial fibrillation, cryptogenic stroke, continuous monitoring, implantable loop recorder, insertable cardiac monitor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
447 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Monitoring
Arm Type
Active Comparator
Arm Description
Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Intervention Type
Device
Intervention Name(s)
Reveal® XT Insertable Cardiac Monitor
Other Intervention Name(s)
Reveal® XT
Intervention Description
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.
Primary Outcome Measure Information:
Title
AF Detection Rate Within 6 Months
Description
Percentage of subjects with AF detected within 6 months of follow-up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
AF Detection Rate Within 12 Months
Description
Percentage of subjects with AF detected within 12 months of follow-up
Time Frame
12 months
Title
Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)
Description
Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up
Time Frame
12 months
Title
Use of Oral Anticoagulation (OAC) Drugs
Description
Percentage of subjects who were using OAC drugs at the 12 months follow-up visit
Time Frame
12 months
Title
Use of Antiarrhythmic Drugs
Description
Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit
Time Frame
12 months
Title
Health Outcome as Evaluated by EQ-5D Questionnaire
Description
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).
Time Frame
12 months
Title
Clinical Disease Burden and Care Pathway
Description
Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months
Time Frame
12 months
Title
Impact of Patient Assistant Use on AF Diagnosis
Description
AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency
Time Frame
Follow-up closure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Brachmann, MD
Organizational Affiliation
Klinikum Coburg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tommaso Sanna, MD
Organizational Affiliation
Catholic University, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans Christoph Diener, MD
Organizational Affiliation
Klinik für Neurologie, Essen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Morillo, MD
Organizational Affiliation
McMaster Clinic, Hamilton, Ontario, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Bernstein, MD, PhD
Organizational Affiliation
Davee Department of Neurology, Chicago, IL USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincenzo Di Lazzaro, MD
Organizational Affiliation
Catholic University Rome, Rome Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rod Passman, MD
Organizational Affiliation
Northwestern Memorial Hospital, Chicago, IL USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marilyn Rymer, MD
Organizational Affiliation
St. Lukes Hospital of Kansas City, Kansas City, MI USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
Country
United States
Facility Name
South Denver Cardiology / Swedish Medical Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Iowa Heart / Ruan Neurology
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
Louisville Cardiology
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Cardiology Associates Research, LLC
City
Tupelo
State/Province
Mississippi
Country
United States
Facility Name
Mid America Heart Institute / St. Lukes Hospital
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Washington University Medical School
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Ohio Health Research
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Sacred Heart Medical Center
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Central Bucks Specialists / Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Lankenau
City
Wynnewood
State/Province
Pennsylvania
Country
United States
Facility Name
Greenville Hospital System Cardiology/Cardiovascular Research
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
St. Thomas Research Institute
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
Country
United States
Facility Name
University of Texas - Southwestern Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
LKH Universitätsklinikum Graz
City
Graz
Country
Austria
Facility Name
AKH Linz
City
Linz
Country
Austria
Facility Name
Landesklinikum Donauregion Tulln
City
Tulln
Country
Austria
Facility Name
UZ Antwerpen
City
Antwerp
Country
Belgium
Facility Name
Brussels Heart Center (St. Lean - St. Pierre)
City
Brussels
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Cliniques Universitaires UCL Mont-Godinne
City
Mont Godinne
Country
Belgium
Facility Name
Hamilton Health Sciences / Hamilton General Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
CHUS / Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Skejby Hospital
City
Aarhus
Country
Denmark
Facility Name
Neurology clinic, Turku University Central Hospital
City
Turku
Country
Finland
Facility Name
Hôpital Saint André -CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
Clinique Parly II - Centre Hospitalier de Versailles
City
Le Chesnay
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
Country
France
Facility Name
Klinikum Coburg GmbH
City
Coburg
State/Province
Bayern
Country
Germany
Facility Name
Knappschaftskrankenhaus Bochum
City
Bochum
Country
Germany
Facility Name
Klinikum Dortmund
City
Dortmund
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
UMG, Goettingen
City
Goettingen
Country
Germany
Facility Name
Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald
City
Greifswald
Country
Germany
Facility Name
Asklepios Altona
City
Hamburg
Country
Germany
Facility Name
Asklepios Barmbek
City
Hamburg
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe GmbH
City
Karlsruhe
Country
Germany
Facility Name
Kreiskrankenhaus Rastatt
City
Rastatt
Country
Germany
Facility Name
Henry Dunant General Hospital
City
Athens
Country
Greece
Facility Name
Ospedale Misericordia di Grosseto
City
Grosseto
Country
Italy
Facility Name
Ospedale di Imperia
City
Imperia
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Rome
Country
Italy
Facility Name
Ospedale Bolognini
City
Seriate
Country
Italy
Facility Name
Atrium Medisch Centrum
City
Heerlen
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Facility Name
NUSCH, a.s. Bratislava
City
Bratislava
Country
Slovakia
Facility Name
VUSCH Kosice
City
Kosice
Country
Slovakia
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Majadahonda
Country
Spain
Facility Name
University Hospital Lund
City
Lund
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
16432246
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.
Results Reference
background
PubMed Identifier
20598970
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.
Results Reference
background
PubMed Identifier
33984539
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.
Results Reference
derived
PubMed Identifier
33789592
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.
Results Reference
derived
PubMed Identifier
30196791
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.
Results Reference
derived
PubMed Identifier
26763225
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.
Results Reference
derived
PubMed Identifier
26182860
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.
Results Reference
derived
PubMed Identifier
24963567
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.
Results Reference
derived

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

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