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

Completed

• Conditions: Stroke; Atrial Fibrillation
• Interventions: Other: Mobile cardiac rhythm monitoring

• Registration Number: NCT01325545
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cryptogenic stroke	Mobile cardiac rhythm monitoring	Patients with stroke of unknown cause after comprehensive conventional evaluation
Stroke of known cause	Mobile cardiac rhythm monitoring	Patients with stroke of known cause determined by comprehensive conventional evaluation

Primary Outcome Measures

Name	Time	Method
Detection of Atrial Fibrillation	21 days	Documented presence of atrial fibrillation detected by the monitoring device and independently confirmed by a board-certified cardiologist

Secondary Outcome Measures

Name	Time	Method
Time to first episode of atrial fibrillation	Within monitoring period (3 weeks)
Atrial Fibrillation Load	Within monitoring period (3 weeks)	Total time that the patient had atrial fibrillation during the monitoring period
Adverse events related to mobile cardiac monitoring	21 days
Symptomatic status of episode of atrial fibrillation	21 days	Presence or absence of symptoms related to the occurrence of paroxysmal atrial fibrillation
Longest duration of episode of atrial fibrillation	21 days