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CompletedNCT01410396Updated Aug 15, 2013

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

An observational study in Atrial Fibrillation and Stroke, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2013-08-15.

Sponsored by Northwestern University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
49
Ages
50 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Atrial Fibrillation
  • Stroke

Keywords

  • Atrial Fibrillation
  • Stroke
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 49 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
49 participants (actual)
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What researchers measure

Primary outcomes

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

    Time frame: 21 days

Secondary outcomes

  1. Recurrent ischemic stroke

    Time frame: 2 years

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Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01410396
Lead sponsor
Northwestern University
Collaborators
LifeWatch Services, Inc.
Responsible party
Richard Bernstein (Associate Professor, Stroke/Cerebrovascular, Northwestern University) — Principal investigator
First posted
Aug 5, 2011
Start date
Apr 2010
Primary completion
May 2012
Completion
May 2013
Last update
Aug 15, 2013

Study contacts

Richard Bernstein, MD, PhD
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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