Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke

July 17, 2019 updated by: Jeffrey Katz, Northwell Health
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 Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Manhasset, New York, United States, 11557
        • North Shore University Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NonCryptogenic Ischemic Stroke Patients
Patients with non-cryptogenic ischemic stroke will be enrolled within 10 days of stroke onset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
Duration of AF Episodes.
Time Frame: 1 year
Duration of AF episodes (mean and range).
1 year
Percentage of Asymptomatic AF
Time Frame: 1 year
Percentage of asymptomatic AF episodes.
1 year
Incidence of Recurrent Stroke
Time Frame: 1 year
Incidence of recurrent ischemic stroke.
1 year
Number of Patients That Had Multiple AF Episodes
Time Frame: 1 year
Number of patients that had multiple AF episodes.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeffrey M. Katz, MD, Northwell Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

September 28, 2017

Study Completion (Actual)

September 28, 2017

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

June 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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