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

Detection of Occult Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke or TIA Using 21-Day Mobile Cardiac Outpatient Telemetry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01325545
Enrollment
132
Registered
2011-03-29
Start date
2009-04-30
Completion date
2011-03-31
Last updated
2011-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

Keywords

Stroke, Atrial Fibrillation

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.

Interventions

OTHERMobile cardiac rhythm monitoring

Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device

Sponsors

Cardionet
CollaboratorINDUSTRY
Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Detection of Atrial Fibrillation21 daysDocumented presence of atrial fibrillation detected by the monitoring device and independently confirmed by a board-certified cardiologist

Secondary

MeasureTime frameDescription
Time to first episode of atrial fibrillationWithin monitoring period (3 weeks)
Atrial Fibrillation LoadWithin monitoring period (3 weeks)Total time that the patient had atrial fibrillation during the monitoring period
Adverse events related to mobile cardiac monitoring21 days
Symptomatic status of episode of atrial fibrillation21 daysPresence or absence of symptoms related to the occurrence of paroxysmal atrial fibrillation
Longest duration of episode of atrial fibrillation21 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026