Clinical trial NCT01325545: Detection of Occult Paroxysmal Atrial Fibrillation After Stroke Using Prolonged Ambulatory Cardiac Monitoring
Official title: Detection of Occult Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke or TIA Using 21-Day Mobile Cardiac Outpatient Telemetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Atrial Fibrillation
Keywords: Stroke
Atrial Fibrillation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Cardionet
First posted: 2011-03-29
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Detection of Atrial Fibrillation
timeFrame: 21 days
Secondary outcomes:
measure: Time to first episode of atrial fibrillation
timeFrame: Within monitoring period (3 weeks)
measure: Atrial Fibrillation Load
timeFrame: Within monitoring period (3 weeks)
measure: Adverse events related to mobile cardiac monitoring
timeFrame: 21 days
measure: Symptomatic status of episode of atrial fibrillation
timeFrame: 21 days
measure: Longest duration of episode of atrial fibrillation
timeFrame: 21 days
Other outcomes:
Locations:
Study officials:
References:
citation: 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.