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

August 3, 2011
August 14, 2013
April 2010
May 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01410396 on ClinicalTrials.gov Archive Site
Recurrent ischemic stroke [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Recurrent ischemic stroke [ Designated as safety issue: Yes ]
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Not Provided
 
Occult Paroxysmal Atrial Fibrillation in Patients With Non-cardioembolic Ischemic Stroke of Determined Mechanism
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

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

  • Atrial Fibrillation
  • Stroke
Not Provided
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
May 2013
May 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01410396
Lifewatch
No
Richard Bernstein, Northwestern University
Northwestern University
LifeWatch Technologies Ltd.
Principal Investigator: Richard Bernstein, MD, PhD Northwestern University
Northwestern University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP