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

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

Interventions

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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

  lead INDUSTRY

Principal Investigators

• Johannes Brachmann, MD · Klinikum Coburg, Germany

• Tommaso Sanna, MD · Catholic University, Italy

• Hans Christoph Diener, MD · Klinik für Neurologie, Essen, Germany

• Carlos Morillo, MD · McMaster Clinic, Hamilton, Ontario, Canada

• Richard Bernstein, MD, PhD · Davee Department of Neurology, Chicago, IL USA

• Vincenzo Di Lazzaro, MD · Catholic University Rome, Rome Italy

• Rod Passman, MD · Northwestern Memorial Hospital, Chicago, IL USA

• Marilyn Rymer, MD · St. Lukes Hospital of Kansas City, Kansas City, MI USA

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

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

Study Locations