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OpenTrials
Completed

NCT Number: NCT01325545

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

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.

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Key information

Conditions

Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile cardiac rhythm monitoring

Other

Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device

Primary outcomes

  1. Detection of Atrial Fibrillation

    Time frame: 21 days

    Documented presence of atrial fibrillation detected by the monitoring device and independently confirmed by a board-certified cardiologist

Secondary outcomes

  1. Time to first episode of atrial fibrillation

    Time frame: Within monitoring period (3 weeks)

  2. Atrial Fibrillation Load

    Time frame: Within monitoring period (3 weeks)

    Total time that the patient had atrial fibrillation during the monitoring period

  3. Adverse events related to mobile cardiac monitoring

    Time frame: 21 days

  4. Symptomatic status of episode of atrial fibrillation

    Time frame: 21 days

    Presence or absence of symptoms related to the occurrence of paroxysmal atrial fibrillation

  5. Longest duration of episode of atrial fibrillation

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Cardionet

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 29, 2011
Registry last updated
Dec 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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