Ischemic StrokeNCT02232022
Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke
A study testing Reveal LINQ Insertable Cardiac Monitor in people with Ischemic Stroke, run by Northwell Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Reveal LINQ Insertable Cardiac Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2014to 28 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Shore University Hospital
Manhasset, New York, 11557
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
About this study
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Reveal LINQ Insertable Cardiac Monitor
- Keywords
- Stroke, Ischemic stroke, Atrial fibrillation, Insertable cardiac monitor, Non-cryptogenic
- Medical subject headings
- Ischemic Stroke, Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal LINQ Insertable Cardiac MonitorDevice
| Study group | Role | What they receive |
|---|---|---|
| NonCryptogenic Ischemic Stroke Patients | Experimental | Patients with non-cryptogenic ischemic stroke will be enrolled within 10 days of stroke onset Receives: Device: Reveal LINQ Insertable Cardiac Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 1 year
Duration of AF Episodes.
Duration of AF episodes (mean and range).
Measured: 1 year
Percentage of Asymptomatic AF
Percentage of asymptomatic AF episodes.
Measured: 1 year
Incidence of Recurrent Stroke
Incidence of recurrent ischemic stroke.
Measured: 1 year
Number of Patients That Had Multiple AF Episodes
Number of patients that had multiple AF episodes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study start1 Sep 2014
- Primary completion28 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Katz, Northwell Health
- Investigators
- Jeffrey M. Katz, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232022
- Sponsor's protocol ID
- 14-336
- Status last verified
- Jun 2019
- First submitted
- 2 Sep 2014
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02232022
- Acronym / sponsor ID
- 14-336
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Ischemic stroke, Atrial fibrillation, Insertable cardiac monitor, Non-cryptogenic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Posted 17 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NonCryptogenic Ischemic Stroke Patients | Experimental | Device: Reveal LINQ Insertable Cardiac MonitorPatients with non-cryptogenic ischemic stroke will be enrolled within 10 days of stroke onset |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reveal LINQ Insertable Cardiac Monitor | Device | NonCryptogenic Ischemic Stroke Patients |
Primary outcome
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.
5 secondary outcomes
Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy.
Time frame: 1 year
Duration of AF Episodes.
Time frame: 1 year
Percentage of Asymptomatic AF
Time frame: 1 year
Incidence of Recurrent Stroke
Time frame: 1 year
Number of Patients That Had Multiple AF Episodes
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey M. Katz, MD principal investigator
Northwell Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reveal LINQ Insertable Cardiac Monitor in people with Ischemic Stroke, run by Northwell Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.