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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NonCryptogenic Ischemic Stroke Patients | Experimental | Patients with non-cryptogenic ischemic stroke will be enrolled within 10 days of stroke onset |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reveal LINQ Insertable Cardiac Monitor | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients | The incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy. | Percentage of patients who are diagnosed with AF who are changed to anticoagulant therapy. | 1 year |
| Duration of AF Episodes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey M. Katz, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11557 | United States | ||
| Long Island Jewish Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | NonCryptogenic Ischemic Stroke Patients | In this pilot prospective cohort study of non-CIS patients from September 2014 to September 2017. Patients were implanted within 10 days of stroke onset with the Reveal LINQ insertable cardiac monitor and monitored until PAF detection or a minimum of 12 months. Inclusion required diagnosis of a non-AF stroke etiology, age≥40, and either a virtual CHADS2 score ≥3 or ≥2 PAF related comorbidities. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NonCryptogenic Ischemic Stroke Patients | In this pilot prospective cohort study of non-CIS patients from September 2014 to September 2017, 53 patients were enrolled. 51/53 patients were implanted within 10 days of stroke onset with the Reveal LINQ insertable cardiac monitor and monitored until PAF detection or a minimum of 12 months. Inclusion required diagnosis of a non-AF stroke etiology, age≥40, and either a virtual CHADS2 score ≥3 or ≥2 PAF related comorbidities. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients | The incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation. | Posted | Count of Participants | Participants | 1 year |
|
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NonCryptogenic Ischemic Stroke Patients | Reveal LINQ Insertable Cardiac Monitor |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Erosion | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 1 patient had a complication of impending device erosion through the skin. Managed with antibiotics and device removal. |
Relatively small sample size limits our study's power to detect and confirm all factors associated with PAF detection. The number of non-PAF patients lost to follow-up by 6 and 12 months that may have resulted in an underestimation of PAF burden.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey M. Katz | Northwell Health | 516-562-3062 | jkatz2@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2014 | Mar 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Duration of AF episodes (mean and range).
| 1 year |
| Percentage of Asymptomatic AF | Percentage of asymptomatic AF episodes. | 1 year |
| Incidence of Recurrent Stroke | Incidence of recurrent ischemic stroke. | 1 year |
| Number of Patients That Had Multiple AF Episodes | Number of patients that had multiple AF episodes. | 1 year |
| New Hyde Park |
| New York |
| 11040 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline AF Assessment | Baseline AF Assessment completed using 24 hour ECG monitoring | Count of Participants | Participants | No |
|
|
| Secondary | Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy. | Percentage of patients who are diagnosed with AF who are changed to anticoagulant therapy. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Duration of AF Episodes. | Duration of AF episodes (mean and range). | Posted | Mean | Full Range | min | 1 year |
|
|
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| Secondary | Percentage of Asymptomatic AF | Percentage of asymptomatic AF episodes. | Posted | Count of Participants | Participants | 1 year |
|
|
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| Secondary | Incidence of Recurrent Stroke | Incidence of recurrent ischemic stroke. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Number of Patients That Had Multiple AF Episodes | Number of patients that had multiple AF episodes. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 1 |
| 51 |
| 0 |
| 51 |
| 1 |
| 51 |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |