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N/A N=53 Diagnostic

Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke

Ischemic Stroke

Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients — 6 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Reveal LINQ Insertable Cardiac Monitor (Device)
Age
Adult, Older Adult · 41+ yrs
Sex
All
Sponsor
Northwell Health
Primary completion
Sep 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients
6
SECONDARY
Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy.
5
SECONDARY
Duration of AF Episodes.
237
SECONDARY
Percentage of Asymptomatic AF
6
SECONDARY
Incidence of Recurrent Stroke
2
SECONDARY
Number of Patients That Had Multiple AF Episodes
4

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02232022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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