Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke
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|ClinicalTrials.gov Identifier: NCT02232022|
Recruitment Status : Completed
First Posted : September 4, 2014
Results First Posted : July 17, 2019
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Device: Reveal LINQ Insertable Cardiac Monitor||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- Duration of AF Episodes. [ Time Frame: 1 year ]Duration of AF episodes (mean and range).
- Percentage of Asymptomatic AF [ Time Frame: 1 year ]Percentage of asymptomatic AF episodes.
- Incidence of Recurrent Stroke [ Time Frame: 1 year ]Incidence of recurrent ischemic stroke.
- Number of Patients That Had Multiple AF Episodes [ Time Frame: 1 year ]Number of patients that had multiple AF episodes.
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
|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|
|Principal Investigator:||Jeffrey M. Katz, MD||Northwell Health|