Occult Paroxysmal Atrial Fibrillation in Patients With Non-cardioembolic Ischemic Stroke of Determined Mechanism

The aim of this study is to determine the yield of 3 weeks outpatient mobile cardiac monitoring for detection of atrial fibrillation in patients with history of stroke of known cause.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation

Detailed Description

Patients will be recruited to wear a outpatient mobile cardiac monitoring device for detection of atrial fibrillation in patients with a history of stroke of known case. Their are not study treatments or interventions, this is an observational trial. Eligible patients must be >50 years old, have a history of ischemic stroke or transient ischemic attack with a documented brain infarction within the prior 12 months. If patients are on anticoagulation therapies, they are eligible for enrollment if the long-term strategy for stroke prevention is anti-platelet therapy and not the oral anti-coagulant itself. Patients must not have an detection of AF and then must successfully activate the lifeStar device for enrollment. At the end of three weeks, the LifeStar device will be over-read and scored for the presence of AF and other clinically significant arrhythmias by the study electrophysiologist, who will determine the occurrence and burden of AF.

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with history of stroke of known mechanism age greater than 50

Description

Inclusion Criteria:

1. Age > 50
2. Ischemic stroke, or transient ischemic attack with documented acute brain infarction, within prior 6 months.
3. Patient does not merit indefinite oral anticoagulation. (Patients requiring temporary OAC for purposes other than recurrent stroke prevention, such as treatment of a deep venous thrombosis, are eligible for enrollment if the long-term secondary stroke preventive strategy is anti-platelet therapy and not OAC).
4. Stroke mechanism is determined to be lacunar stroke, large vessel intracranial atherosclerosis, large vessel extracranial atherosclerosis, or a combination thereof.
5. Patient has been evaluated with at least a 12 lead EKG and at least one day of in-patient or out-patient cardiac telemetry, with no detection of AF or atrial flutter.
6. Detection of AF or atrial flutter would change secondary prevention antithrombotic strategy (eg to indefinite OAC).
7. Patient receives and successfully activates LifeStar ACT device.
8. Patient or legally authorized representative signs informed consent.

Exclusion Criteria:

1. Known history of AF or atrial flutter.
2. Patient has defibrillator or pacemaker capable of detecting AF.
3. Patient has indication for indefinite OAC.
4. Patient has indefinite contra-indication to OAC. (Patients with temporary ineligibility for OAC, for example due to the need for invasive medical procedures or large acute brain infarction, are eligible for enrollment).
5. Stroke due to known cause not listed in inclusion criterion 4.
6. Cardioembolic stroke.
7. Inability to comply with LifeStar ACT monitoring regimen.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection of any episode of AF >30 seconds during 21 days of mobile outpatient cardiac telemetry	21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Recurrent ischemic stroke	2 years

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: LifeWatch Services, Inc.
• Investigators: Principal Investigator: Richard Bernstein, MD, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: August 4, 2011
• First Posted (Estimate): August 5, 2011

Study Record Updates

• Last Update Posted (Estimate): August 15, 2013
• Last Update Submitted That Met QC Criteria: August 14, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Stroke; Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Ischemic Stroke; Atrial Fibrillation
• Other Study ID Numbers: Lifewatch