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

This study has been completed.

Sponsor:

Collaborator:

Cardionet

Information provided by (Responsible Party):

Alejandro Rabinstein, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01325545

First received: March 28, 2011

Last updated: December 21, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 28, 2011
Last Updated Date	December 21, 2011
Start Date ^ICMJE	April 2009
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 28, 2011)	Detection of Atrial Fibrillation [ Time Frame: 21 days ] [ Designated as safety issue: No ] Documented presence of atrial fibrillation detected by the monitoring device and independently confirmed by a board-certified cardiologist
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01325545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 21, 2011)	Time to first episode of atrial fibrillation [ Time Frame: Within monitoring period (3 weeks) ] [ Designated as safety issue: No ] Atrial Fibrillation Load [ Time Frame: Within monitoring period (3 weeks) ] [ Designated as safety issue: No ] Total time that the patient had atrial fibrillation during the monitoring period Adverse events related to mobile cardiac monitoring [ Time Frame: 21 days ] [ Designated as safety issue: Yes ] Symptomatic status of episode of atrial fibrillation [ Time Frame: 21 days ] [ Designated as safety issue: No ] Presence or absence of symptoms related to the occurrence of paroxysmal atrial fibrillation Longest duration of episode of atrial fibrillation [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 28, 2011)	Time to first episode of atrial fibrillation [ Designated as safety issue: No ] Atrial Fibrillation Load [ Designated as safety issue: No ] Total time that the patient had atrial fibrillation during the monitoring period Adverse events related to mobile cardiac monitoring [ Time Frame: 21 days ] [ Designated as safety issue: Yes ] Symptomatic status of episode of atrial fibrillation [ Time Frame: 21 days ] [ Designated as safety issue: No ] Presence or absence of symptoms related to the occurrence of paroxysmal atrial fibrillation Longest duration of episode of atrial fibrillation [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Detection of Occult Paroxysmal Atrial Fibrillation After Stroke Using Prolonged Ambulatory Cardiac Monitoring
Official Title ^ICMJE	Detection of Occult Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke or TIA Using 21-Day Mobile Cardiac Outpatient Telemetry
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: To determine the prevalence of occult paroxysmal atrial fibrillation in patients with cryptogenic stroke using long-term mobile cardiac outpatient telemetry. To compare this prevalence to that found in a control group with stroke of known, non-cardioembolic cause. To look for clinical, laboratory, echocardiographic, and imaging data that serve as risk factors for occult paroxysmal atrial fibrillation in patients with cryptogenic stroke. To examine the utility of mobile cardiac outpatient telemetry, a relatively new diagnostic tool, in the evaluation of patients with cryptogenic stroke.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Stroke Atrial Fibrillation
Intervention ^ICMJE	Other: Mobile cardiac rhythm monitoring Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device
Study Group/Cohort (s)	Cryptogenic stroke Patients with stroke of unknown cause after comprehensive conventional evaluation Intervention: Other: Mobile cardiac rhythm monitoring Stroke of known cause Patients with stroke of known cause determined by comprehensive conventional evaluation Intervention: Other: Mobile cardiac rhythm monitoring
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	132
Completion Date	March 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01325545
Other Study ID Numbers ^ICMJE	08-003788
Has Data Monitoring Committee	No
Responsible Party	Alejandro Rabinstein, Mayo Clinic
Study Sponsor ^ICMJE	Mayo Clinic
Collaborators ^ICMJE	Cardionet
Investigators ^ICMJE	Not Provided
Information Provided By	Mayo Clinic
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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