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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325545
• Other study ID #: 08-003788
• Status: Completed
• Phase: N/A
• First received: March 28, 2011
• Last updated: December 21, 2011
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: December 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Other:
• Mobile cardiac rhythm monitoring
Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Cardionet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Atrial Fibrillation	Documented presence of atrial fibrillation detected by the monitoring device and independently confirmed by a board-certified cardiologist	21 days	No
Secondary	Time to first episode of atrial fibrillation		Within monitoring period (3 weeks)	No
Secondary	Atrial Fibrillation Load	Total time that the patient had atrial fibrillation during the monitoring period	Within monitoring period (3 weeks)	No
Secondary	Adverse events related to mobile cardiac monitoring		21 days	Yes
Secondary	Symptomatic status of episode of atrial fibrillation	Presence or absence of symptoms related to the occurrence of paroxysmal atrial fibrillation	21 days	No
Secondary	Longest duration of episode of atrial fibrillation		21 days	No