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

This study is currently recruiting participants.
Verified August 2011 by Northwestern University
Sponsor:
Collaborator:
Lifewatch Corp
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01410396
First received: August 3, 2011
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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.


Condition
Atrial Fibrillation
Stroke

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Detection of any episode of AF >30 seconds during 21 days of mobile outpatient cardiac telemetry [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrent ischemic stroke [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2010
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410396

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Kathryn L Muskovich     312-503-0492     k-muskovich@northwestern.edu    
Principal Investigator: Richard A Bernstein, MD, PhD            
Sponsors and Collaborators
Northwestern University
Lifewatch Corp
  More Information

No publications provided

Responsible Party: Richard Bernstein, MD, PhD, Northwestern University
ClinicalTrials.gov Identifier: NCT01410396     History of Changes
Other Study ID Numbers: Lifewatch
Study First Received: August 3, 2011
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Atrial Fibrillation
Stroke

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Cerebral Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 19, 2013