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

NCT01410396 | Completed

• 1 other identifier: Lifewatch
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Stroke

Keywords

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (1)

• Detection of any episode of AF >30 seconds during 21 days of mobile outpatient cardiac telemetry

  21 days

Secondary Outcomes (1)

• Recurrent ischemic stroke

  2 years

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age \> 50
• Ischemic stroke, or transient ischemic attack with documented acute brain infarction, within prior 6 months.
• 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).
• Stroke mechanism is determined to be lacunar stroke, large vessel intracranial atherosclerosis, large vessel extracranial atherosclerosis, or a combination thereof.
• 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.
• Detection of AF or atrial flutter would change secondary prevention antithrombotic strategy (eg to indefinite OAC).
• Patient receives and successfully activates LifeStar ACT device.
• Patient or legally authorized representative signs informed consent.

You may not qualify if:

• Known history of AF or atrial flutter.
• Patient has defibrillator or pacemaker capable of detecting AF.
• Patient has indication for indefinite OAC.
• 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).
• Cardioembolic stroke.
• Inability to comply with LifeStar ACT monitoring regimen.

Sponsors & Collaborators

• Northwestern University: lead
• LifeWatch Services, Inc.: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Bernstein, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Stroke/Cerebrovascular

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 5, 2011
• Study Start: April 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2013
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

US (1)