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

NCT00924638 | Completed Phase 4 Results DMC

• 1 other identifier: CRYSTAL-AF
• Study Type: interventional
• Target: 447
• Locations: 14 countries
• Sites: 55

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.

Conditions

Cryptogenic Symptomatic Transient Ischemic Attack; Cryptogenic Ischemic Stroke

Keywords

atrial fibrillation; cryptogenic stroke; continuous monitoring; implantable loop recorder; insertable cardiac monitor

Outcome Measures

Primary Outcomes (1)

• AF Detection Rate Within 6 Months

  Percentage of subjects with AF detected within 6 months of follow-up

  6 months

Secondary Outcomes (7)

• AF Detection Rate Within 12 Months

  12 months

• Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)

  12 months

• Use of Oral Anticoagulation (OAC) Drugs

  12 months

• Use of Antiarrhythmic Drugs

  12 months

• Health Outcome as Evaluated by EQ-5D Questionnaire

  12 months

Study Arms (2)

Continuous Monitoring

ACTIVE COMPARATOR

Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor

Device: Reveal® XT Insertable Cardiac Monitor

Control Arm

NO INTERVENTION

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

Interventions

Reveal® XT Insertable Cardiac Monitor DEVICE

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.

Also known as: Reveal® XT

Continuous Monitoring

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (55)

El Camino Hospital

Mountain View, California, United States

Location

South Denver Cardiology / Swedish Medical Center

Denver, Colorado, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, United States

Location

Iowa Heart / Ruan Neurology

Des Moines, Iowa, United States

Location

Louisville Cardiology

Louisville, Kentucky, United States

Location

Cardiology Associates Research, LLC

Tupelo, Mississippi, United States

Location

Mid America Heart Institute / St. Lukes Hospital

Kansas City, Missouri, United States

Location

Washington University Medical School

St Louis, Missouri, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Location

Ohio Health Research

Columbus, Ohio, United States

Location

Sacred Heart Medical Center

Eugene, Oregon, United States

Location

Central Bucks Specialists / Doylestown Hospital

Doylestown, Pennsylvania, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Location

Lankenau

Wynnewood, Pennsylvania, United States

Location

Greenville Hospital System Cardiology/Cardiovascular Research

Greenville, South Carolina, United States

Location

St. Thomas Research Institute

Nashville, Tennessee, United States

Location

Baylor Research Institute

Dallas, Texas, United States

Location

University of Texas - Southwestern Medical Center

Dallas, Texas, United States

Location

LKH Universitätsklinikum Graz

Graz, Austria

Location

AKH Linz

Linz, Austria

Location

Landesklinikum Donauregion Tulln

Tulln, Austria

Location

UZ Antwerpen

Antwerp, Belgium

Location

Brussels Heart Center (St. Lean - St. Pierre)

Brussels, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

Cliniques Universitaires UCL Mont-Godinne

Mont Godinne, Belgium

Location

Hamilton Health Sciences / Hamilton General Hospital

Hamilton, Ontario, Canada

Location

CHUS / Hopital Fleurimont

Sherbrooke, Quebec, Canada

Location

Skejby Hospital

Aarhus, Denmark

Location

Neurology clinic, Turku University Central Hospital

Turku, Finland

Location

Hôpital Saint André -CHU de Bordeaux

Bordeaux, France

Location

Clinique Parly II - Centre Hospitalier de Versailles

Le Chesnay, France

Location

Hôpital de la Timone

Marseille, France

Location

Klinikum Coburg GmbH

Coburg, Bavaria, Germany

Location

Knappschaftskrankenhaus Bochum

Bochum, Germany

Location

Klinikum Dortmund

Dortmund, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

UMG, Goettingen

Göttingen, Germany

Location

Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald

Greifswald, Germany

Location

Asklepios Altona

Hamburg, Germany

Location

Asklepios Barmbek

Hamburg, Germany

Location

Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, Germany

Location

Kreiskrankenhaus Rastatt

Rastatt, Germany

Location

Henry Dunant General Hospital

Athens, Greece

Location

Ospedale Misericordia di Grosseto

Grosseto, Italy

Location

Ospedale di Imperia

Imperia, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, Italy

Location

Ospedale Bolognini

Seriate, Italy

Location

Atrium Medisch Centrum

Heerlen, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

NUSCH, a.s. Bratislava

Bratislava, Slovakia

Location

VUSCH Kosice

Košice, Slovakia

Location

Hospital Puerta de Hierro Majadahonda

Majadahonda, Spain

Location

University Hospital Lund

Lund, Sweden

Location

Related Publications (8)

• 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.

  PMID: 16432246 BACKGROUND

• 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.

  PMID: 20598970 BACKGROUND

• 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.

  PMID: 33984539 DERIVED

• 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.

  PMID: 33789592 DERIVED

• 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.

  PMID: 30196791 DERIVED

• 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.

  PMID: 26763225 DERIVED

• 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.

  PMID: 26182860 DERIVED

• 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.

  PMID: 24963567 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medtronic CRDM clinical trial manager
• Organization: Medtronic, Inc.

medtronicCRMtrials@medtronic.com

763-505-6000

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 19, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 28, 2014
• Results First Posted: July 28, 2014

Record last verified: 2014-01

Locations

GR (1); BE (4); AU (3); SL (2); IT (4); DE (10); FI (1); US (19); ES (1); DK (1); FR (3); NL (3); CA (2); SE (1)