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Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02232022
Recruitment Status : Completed
First Posted : September 4, 2014
Results First Posted : July 17, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Katz, Northwell Health

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: Reveal LINQ Insertable Cardiac Monitor Not Applicable

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, however, requires prolonged cardiac monitoring. On the other hand, there is no understanding of the frequency of silent PAF in patients with a "known" or presumed etiology for their ischemic stroke other than AF. If this incidence is also found to be significant, a dramatic change in stroke evaluation and management would likely occur. This study intends to find the incidence of PAF in a population of recent (within 7 days) ischemic stroke patients (or MRI positive "transient ischemic attack (TIA)" patients) who have presumed etiology for their stroke other than atrial fibrillation or other high risk cardiac lesion. Stroke etiology will be determined through a standard post-stroke evaluation that includes:

  • Brain MRI
  • 12-lead electrocardiogram (ECG) for AF detection
  • 24-h ECG monitoring for AF detection (eg, Holter monitor or cardiac telemetry)
  • Transthoracic and/or Transesophageal echocardiogram
  • CT or MR angiography of the head and neck
  • Hypercoagulable blood panel for patients less than 55 years-old. Preliminary hypercoagulable work-up within 7 days will include the antiphospholipid antibody syndrome results, which will be needed to determine stroke management. All other results, which could take longer to return, including genetic tests of hypercoagulability, rarely change stroke management.

To find occult PAF in this population, participants will have an insertable cardiac monitor (Reveal LINQ ICM) implanted within 7 days of the incident stroke and will be monitored for at least 1 year.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : September 28, 2017
Actual Study Completion Date : September 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NonCryptogenic Ischemic Stroke Patients
Patients with non-cryptogenic ischemic stroke will be enrolled within 10 days of stroke onset
Device: Reveal LINQ Insertable Cardiac Monitor



Primary Outcome Measures :
  1. Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients [ Time Frame: 1 year ]
    The incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.


Secondary Outcome Measures :
  1. Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy. [ Time Frame: 1 year ]
    Percentage of patients who are diagnosed with AF who are changed to anticoagulant therapy.

  2. Duration of AF Episodes. [ Time Frame: 1 year ]
    Duration of AF episodes (mean and range).

  3. Percentage of Asymptomatic AF [ Time Frame: 1 year ]
    Percentage of asymptomatic AF episodes.

  4. Incidence of Recurrent Stroke [ Time Frame: 1 year ]
    Incidence of recurrent ischemic stroke.

  5. Number of Patients That Had Multiple AF Episodes [ Time Frame: 1 year ]
    Number of patients that had multiple AF episodes.



Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232022


Locations
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United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11557
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Jeffrey M. Katz, MD Northwell Health
  Study Documents (Full-Text)

Documents provided by Jeffrey Katz, Northwell Health:

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Responsible Party: Jeffrey Katz, Chief, Vascular Neurology, Northwell Health
ClinicalTrials.gov Identifier: NCT02232022    
Other Study ID Numbers: 14-336
First Posted: September 4, 2014    Key Record Dates
Results First Posted: July 17, 2019
Last Update Posted: July 30, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeffrey Katz, Northwell Health:
Stroke
Ischemic stroke
Atrial fibrillation
Insertable cardiac monitor
Non-cryptogenic
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Atrial Fibrillation
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia