Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke

Description

The purpose of this study is to determine the incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.

Study Start Date

September 2014

Estimated Completion Date

October 2016

Interventions

  • Device: Reveal LINQ Insertable Cardiac Monitor

Specialties

  • Cardiology: Arrhythmias/EP,Vascular Medicine
  • Physician Assistant: Cardiology

MeSH Terms

  • Atrial Fibrillation
  • Atrial Fibrillation
  • Cerebral Infarction
  • Stroke

Study ID

North Shore Long Island Jewish Health System -- 14-336

Status

Unknown

Trial ID

NCT02232022

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

75

Sponsor

North Shore Long Island Jewish Health System

Inclusion Criteria

  • Patients with a recent ischemic stroke or transient ischemic attack (TIA) with brain infarction on brain imaging.
  • No history of atrial fibrillation or finding of atrial fibrillation on standard inpatient monitoring (electrocardiogram, telemetry, 24-hour Holter monitor)
  • Have a presumed stroke etiology: Lacunar or small vessel thrombosis, extra-cranial or intracranial atherosclerotic stenosis or dissection, arteriopathy or vasculitis, hypercoagulable state, aortic arch plaque with or without mobile elements, or evidence of a low-risk cardiac source (e.g., patent foramen ovale with or without atrial septal aneurysm and with or without evidence of venous thromboembolic source).
  • Have virtual CHADS2 score ?3 or
  • Have 2 or more of the following co-morbidities: obstructive sleep apnea, coronary artery disease, (Chronic Pulmonary Obstructive Disease (COPD), hyperthyroidism, Body Mass Index> 30, prior myocardial infarction, prolonged PR interval (>175 ms) or renal impairment (GFR 30-60).
  • Patient or legally authorized representative who is willing to sign written consent form.
  • Patient is ?40 years old (patients younger than 40 years old have a very low likelihood of having atrial fibrillation and are therefore excluded from the study).
  • Patient can have the device implanted within 7 days of the incident ischemic event

Exclusion Criteria

  • Documented history of AF or atrial flutter.
  • Evidence of a high-risk cardiac source of embolism (Left Ventricular or Left Atrial thrombus or "smoke," emboligenic valvular lesion or tumor)
  • Untreated hyperthyroidism.
  • Myocardial infarction or coronary bypass grafting within 1 month prior to the stroke/TIA.
  • Valvular disease requiring immediate surgical intervention.
  • Permanent indication for anticoagulation at enrollment.
  • Permanent oral anticoagulation contraindication.
  • Already included in another clinical trial that will affect the objectives of this study.
  • Life expectancy is less than 1 year.
  • Pregnancy. Urine or serum pregnancy test is required for women of child bearing potential to exclude pregnancy.
  • Patient is indicated for implant with a pacemaker, implantable cardioverter-defibrillator, CRT device, or an implantable hemodynamic monitoring system
  • Patient is not fit, or is unable or unwilling to follow the required procedures of the Clinical Investigation Plan.
  • Cryptogenic Stroke: A stroke/TIA will be considered cryptogenic if no cause is determined despite extensive inpatient workup according to the standard diagnostic protocol at North Shore University Hospital.

Gender

Both

Ages

41 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
North Shore University Hospital - Manhasset, New York 46.8 miles None None None

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