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

December 21, 2011 updated by: Alejandro Rabinstein, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cryptogenic stroke
Patients with stroke of unknown cause after comprehensive conventional evaluation
Other: Mobile cardiac rhythm monitoring
Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device
Stroke of known cause
Patients with stroke of known cause determined by comprehensive conventional evaluation
Other: Mobile cardiac rhythm monitoring
Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
21 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Cardionet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Estimate)

December 23, 2011

Last Update Submitted That Met QC Criteria

December 21, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-003788

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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