Status:
COMPLETED
Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke
Lead Sponsor:
Northwell Health
Conditions:
Ischemic Stroke
Eligibility:
All Genders
41+ years
Phase:
NA
Brief Summary
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.
Detailed Description
Recent studies suggest that their is a relatively high incidence of silent paroxysmal atrial fibrillation (PAF) in cryptogenic ischemic stroke patients. Detection of silent PAF in this population, how...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2017
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02232022
Start Date
September 1 2014
End Date
September 28 2017
Last Update
July 30 2019
Active Locations (2)
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1
North Shore University Hospital
Manhasset, New York, United States, 11557
2
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040