Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke

NCT02232022 | Completed Results DMC

• 1 other identifier: 14-336
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Stroke

Keywords

Stroke; Ischemic stroke; Atrial fibrillation; Insertable cardiac monitor; Non-cryptogenic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy.

  1 year

• Duration of AF Episodes.

  1 year

• Percentage of Asymptomatic AF

  1 year

• Incidence of Recurrent Stroke

  1 year

• Number of Patients That Had Multiple AF Episodes

  1 year

Study Arms (1)

NonCryptogenic Ischemic Stroke Patients

EXPERIMENTAL

Patients with non-cryptogenic ischemic stroke will be enrolled within 10 days of stroke onset

Device: Reveal LINQ Insertable Cardiac Monitor

Interventions

Reveal LINQ Insertable Cardiac Monitor DEVICE

NonCryptogenic Ischemic Stroke Patients

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (2)

North Shore University Hospital

Manhasset, New York, 11557, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Jeffrey M. Katz
• Organization: Northwell Health

jkatz2@northwell.edu

516-562-3062

Study Officials

• Jeffrey M. Katz, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Vascular Neurology

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 4, 2014
• Study Start: September 1, 2014
• Primary Completion: September 28, 2017
• Study Completion: September 28, 2017
• Last Updated: July 30, 2019
• Results First Posted: July 17, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)