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

NCT ID: NCT01325545

Last Updated: 2011-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Atrial Fibrillation

Keywords

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Stroke Atrial Fibrillation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cryptogenic stroke

Patients with stroke of unknown cause after comprehensive conventional evaluation

Mobile cardiac rhythm monitoring

Intervention Type OTHER

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

Mobile cardiac rhythm monitoring

Intervention Type OTHER

Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device

Interventions

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Mobile cardiac rhythm monitoring

Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardionet

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Alejandro Rabinstein

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Baturova MA, Sheldon SH, Carlson J, Brady PA, Lin G, Rabinstein AA, Friedman PA, Platonov PG. Electrocardiographic and Echocardiographic predictors of paroxysmal atrial fibrillation detected after ischemic stroke. BMC Cardiovasc Disord. 2016 Nov 3;16(1):209. doi: 10.1186/s12872-016-0384-2.

Reference Type DERIVED
PMID: 27809773 (View on PubMed)

Other Identifiers

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08-003788

Identifier Type: -

Identifier Source: org_study_id