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Detection of Occult Paroxysmal Atrial Fibrillation After Stroke Using Prolonged Ambulatory Cardiac Monitoring

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ClinicalTrials.gov Identifier: NCT01325545
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : December 23, 2011
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Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

About one-third of patients with stroke have no documented cause for the cerebrovascular event (known as cryptogenic strokes). Atrial fibrillation is a common cause of stroke, but when transient (paroxysmal) it may remain undiagnosed. Recent data suggest that occult paroxysmal atrial fibrillation may be identified in patients with cryptogenic strokes using prolonged ambulatory cardiac rhythm monitors.

The investigators designed this study pursuing the following goals:

  1. To determine the prevalence of occult paroxysmal atrial fibrillation in patients with cryptogenic stroke using long-term mobile cardiac outpatient telemetry.
  2. To compare this prevalence to that found in a control group with stroke of known, non-cardioembolic cause.
  3. To look for clinical, laboratory, echocardiographic, and imaging data that serve as risk factors for occult paroxysmal atrial fibrillation in patients with cryptogenic stroke.
  4. To examine the utility of mobile cardiac outpatient telemetry, a relatively new diagnostic tool, in the evaluation of patients with cryptogenic stroke.

Condition or disease Intervention/treatment
Stroke Atrial Fibrillation Other: Mobile cardiac rhythm monitoring

Study Design

Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Detection of Occult Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke or TIA Using 21-Day Mobile Cardiac Outpatient Telemetry
Study Start Date : April 2009
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Cryptogenic stroke
Patients with stroke of unknown cause after comprehensive conventional evaluation
Other: Mobile cardiac rhythm monitoring
Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device
Stroke of known cause
Patients with stroke of known cause determined by comprehensive conventional evaluation
Other: Mobile cardiac rhythm monitoring
Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device


Outcome Measures

Primary Outcome Measures :
  1. Detection of Atrial Fibrillation [ Time Frame: 21 days ]
    Documented presence of atrial fibrillation detected by the monitoring device and independently confirmed by a board-certified cardiologist


Secondary Outcome Measures :
  1. Time to first episode of atrial fibrillation [ Time Frame: Within monitoring period (3 weeks) ]
  2. Atrial Fibrillation Load [ Time Frame: Within monitoring period (3 weeks) ]
    Total time that the patient had atrial fibrillation during the monitoring period

  3. Adverse events related to mobile cardiac monitoring [ Time Frame: 21 days ]
  4. Symptomatic status of episode of atrial fibrillation [ Time Frame: 21 days ]
    Presence or absence of symptoms related to the occurrence of paroxysmal atrial fibrillation

  5. Longest duration of episode of atrial fibrillation [ Time Frame: 21 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stroke or TIA confirmed by a vascular neurologist within previous 3 months with complete evaluation for stroke causes according to current standards.
Criteria

Inclusion Criteria:

  • Stroke or TIA within previous 3 months
  • Stroke work up including: EKG, serum lipids, serum TSH, TTE or TEE, brain CT and/or MRI, Vascular Evaluation of head and neck using any combination of ultrasound, MRA, CTA, and conventional angiography

Exclusion Criteria:

  • Documented history of atrial fibrillation or flutter
  • PFO closure planned before conclusion of the monitoring period
  • Incomplete stroke work up
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alejandro Rabinstein, Professor of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01325545     History of Changes
Other Study ID Numbers: 08-003788
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

Keywords provided by Alejandro Rabinstein, Mayo Clinic:
Stroke
Atrial Fibrillation

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