Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke
Completed · Not applicable
Conditions studied: Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT02232022
- Run by
- Northwell Health
- People needed
- 53
- Starts
- 2014-09-01
- Expected to finish
- 2017-09-28
- Last updated by the study team
- 2019-07-30
Who can join
Age: 41 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- North Shore University Hospital — Manhasset, New York, United States
- Long Island Jewish Medical Center — New Hyde Park, New York, United States
Full record on ClinicalTrials.gov
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