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

This study has been completed.
Sponsor:
Collaborator:
LifeWatch Technologies Ltd.
Information provided by (Responsible Party):
Richard Bernstein, Northwestern University
ClinicalTrials.gov Identifier:
NCT01410396
First received: August 3, 2011
Last updated: August 14, 2013
Last verified: August 2013
  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
Official Title: Occult Paroxysmal Atrial Fibrillation in Patients With Non-cardioembolic Ischemic Stroke of Determined Mechanism

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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: April 2010
Study Completion Date: May 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
LifeWatch Technologies Ltd.
Investigators
Principal Investigator: Richard Bernstein, MD, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Richard Bernstein, Associate Professor, Stroke/Cerebrovascular, Northwestern University
ClinicalTrials.gov Identifier: NCT01410396     History of Changes
Other Study ID Numbers: Lifewatch
Study First Received: August 3, 2011
Last Updated: August 14, 2013
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 July 31, 2014