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

March 28, 2011
December 21, 2011
April 2009
March 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01325545 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Detection of Occult Paroxysmal Atrial Fibrillation After Stroke Using Prolonged Ambulatory Cardiac Monitoring
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with stroke or TIA confirmed by a vascular neurologist within previous 3 months with complete evaluation for stroke causes according to current standards.

  • Stroke
  • Atrial Fibrillation
Other: Mobile cardiac rhythm monitoring
Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01325545
08-003788
No
Alejandro Rabinstein, Mayo Clinic
Mayo Clinic
Cardionet
Not Provided
Mayo Clinic
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP