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
  Purpose

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.

Condition Intervention
Stroke
Atrial Fibrillation
Other: Mobile cardiac rhythm monitoring

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Detection of Occult Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke or TIA Using 21-Day Mobile Cardiac Outpatient Telemetry

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 132
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alejandro Rabinstein, Professor of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01325545     History of Changes
Other Study ID Numbers: 08-003788
Study First Received: March 28, 2011
Last Updated: December 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Stroke
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Cerebral Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 01, 2014