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

NCT01325545 | Completed

• 1 other identifier: 08-003788
• Study Type: observational
• Target: 132
• Locations: 0 countries
• Sites: N/A

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:

1. 1.To determine the prevalence of occult paroxysmal atrial fibrillation in patients with cryptogenic stroke using long-term mobile cardiac outpatient telemetry.
2. 2.To compare this prevalence to that found in a control group with stroke of known, non-cardioembolic cause.
3. 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. 4.To examine the utility of mobile cardiac outpatient telemetry, a relatively new diagnostic tool, in the evaluation of patients with cryptogenic stroke.

Conditions

Stroke; Atrial Fibrillation

Keywords

Stroke; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Detection of Atrial Fibrillation

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

  21 days

Secondary Outcomes (5)

• Time to first episode of atrial fibrillation

  Within monitoring period (3 weeks)

• Atrial Fibrillation Load

  Within monitoring period (3 weeks)

• Adverse events related to mobile cardiac monitoring

  21 days

• Symptomatic status of episode of atrial fibrillation

  21 days

• Longest duration of episode of atrial fibrillation

  21 days

Study Arms (2)

Cryptogenic stroke

Patients with stroke of unknown cause after comprehensive conventional evaluation

Other: Mobile cardiac rhythm monitoring

Stroke of known cause

Patients with stroke of known cause determined by comprehensive conventional evaluation

Other: Mobile cardiac rhythm monitoring

Interventions

Mobile cardiac rhythm monitoring OTHER

Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device

Cryptogenic stroke; Stroke of known cause

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Documented history of atrial fibrillation or flutter
• PFO closure planned before conclusion of the monitoring period
• Incomplete stroke work up

Sponsors & Collaborators

• Mayo Clinic: lead
• Cardionet: collaborator

Related Publications (1)

• Baturova MA, Sheldon SH, Carlson J, Brady PA, Lin G, Rabinstein AA, Friedman PA, Platonov PG. Electrocardiographic and Echocardiographic predictors of paroxysmal atrial fibrillation detected after ischemic stroke. BMC Cardiovasc Disord. 2016 Nov 3;16(1):209. doi: 10.1186/s12872-016-0384-2.

  PMID: 27809773 DERIVED

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 29, 2011
• Study Start: April 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 23, 2011

Record last verified: 2011-12