Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

Stroke AF - Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF) through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™ Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC) medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known origin.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: Reveal LINQ™ Insertable Cardiac Monitor

Detailed Description

Stroke AF is a prospective, multi-site, randomized, controlled, non-blinded, post-market study. The Stroke AF study will compare the incidence rate of atrial fibrillation through 12 months between the continuous monitoring arm and the control arm in subjects with a recent ischemic stroke of presumed known origin. Subjects randomized to the continuous monitoring arm will have a Reveal LINQ Insertable Cardiac Monitor inserted within 10 days of the qualifying stroke and undergo continuous remote monitoring. Subjects randomized to the control arm will be followed per site specific standard of care.

• Study Type: Interventional
• Enrollment (Actual): 496
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Cardiovascular Associates of the Southeast
  • California
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital La Jolla
    • San Francisco, California, United States, 94143
      • University of California San Francisco UCSF Medical Center
  • Florida
    • Aventura, Florida, United States, 33180
      • Innovative Medical Research of South Florida
    • Miami, Florida, United States, 33136
      • University of Miami Hospital
    • Orlando, Florida, United States, 32803
      • AdventHealth Neuroscience Institute
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • The Queens Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
    • Louisville, Kentucky, United States, 40202
      • Norton Neuroscience Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70201
      • Ochsner Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Bloomington, Minnesota, United States, 55101
      • Health Partners Institute (Bloomington MN)
    • Saint Louis Park, Minnesota, United States, 55426
      • Health Partners Institute (Saint Louis Park MN)
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Clinic Cardiology
    • Springfield, Missouri, United States, 65807
      • Cox Medical Center South
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • Albany, New York, United States, 12211
      • Albany Medical Center
    • Buffalo, New York, United States, 14203
      • University at Buffalo, The State University of New York
    • New Hyde Park, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • Summit, New York, United States, 07901
      • Overlook Medical Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Cone Health
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • The University of Oklahoma Health Sciences Center
  • Oregon
    • Springfield, Oregon, United States, 97477
      • PeaceHealth Sacred Heart Medical Center at Riverbend
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster General Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Institute for Medical Research
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Saint Thomas Research Institute
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
    • Dallas, Texas, United States, 75390
      • University of Texas (UT) Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Centra Medical Group Stroobants Cardiovascular Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject has had an ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days
• Subject is willing and able to undergo study requirements and expected to be geographically stable during study follow-up

• Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke:

  • Congestive heart failure
  • Hypertension (Systolic Blood Pressure > 140)
  • Diabetes Mellitus
  • Prior Stroke (>90 days ago, other than study qualifying index event)
  • Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque)

Exclusion Criteria:

• Subject has had a cryptogenic stroke
• Subject has had a cardioembolic stroke
• Subject has untreated hyperthyroidism
• Subject has had a recent myocardial infarction <1 month of stroke
• Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) <1 month of stroke
• Subject has a mechanical heart valve
• Subject has valvular disease requiring immediate surgical intervention
• Subject has documented prior history of atrial fibrillation or atrial flutter
• Subject has permanent indication for oral anticoagulation
• Subject has permanent contraindication to oral anticoagulation such that detection of AF would not change medical management, based on enrolling investigators judgment
• Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee.
• Subject's life expectancy is less than 1 year
• Subject is pregnant
• Subject has or is indicated for implant with a pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac ResynchronizationTherapy (CRT), or an implantable hemodynamic monitor
• Subject with a medical condition that precludes the patient from participation in the opinion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reveal LINQ™ Insertable Cardiac Monitor; Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.	Device: Reveal LINQ™ Insertable Cardiac Monitor; The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.; Other Names: LINQ; LINQ™
No Intervention: Control Arm; Subjects randomized to the control arm will be followed per site specific standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin.	AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms.	AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis.	3 years

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Chair: Richard Bernstein, PhD/MD, Northwestern; Study Chair: Lee Schwamm, MD, Mass General

Publications and helpful links

General Publications

• Zachrison KS, Amati V, Schwamm LH, Yan Z, Nielsen V, Christie A, Reeves MJ, Sauser JP, Lomi A, Onnela JP. Influence of Hospital Characteristics on Hospital Transfer Destinations for Patients With Stroke. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e008269. doi: 10.1161/CIRCOUTCOMES.121.008269. Epub 2022 Apr 4.
• Bernstein RA, Kamel H, Granger CB, Piccini JP, Sethi PP, Katz JM, Vives CA, Ziegler PD, Franco NC, Schwamm LH; STROKE-AF Investigators. Effect of Long-term Continuous Cardiac Monitoring vs Usual Care on Detection of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease: The STROKE-AF Randomized Clinical Trial. JAMA. 2021 Jun 1;325(21):2169-2177. doi: 10.1001/jama.2021.6470.
• Schwamm LH, Kamel H, Granger CB, Piccini JP, Katz JM, Sethi PP, Sidorov EV, Kasner SE, Silverman SB, Merriam TT, Franco N, Ziegler PD, Bernstein RA; STROKE AF Investigators. Predictors of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease: A Prespecified Secondary Analysis of the STROKE AF Randomized Clinical Trial. JAMA Neurol. 2023 Jan 1;80(1):99-103. doi: 10.1001/jamaneurol.2022.4038.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): August 3, 2020
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimated): March 7, 2016

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Ischemic Stroke; Atrial Fibrillation
• Other Study ID Numbers: Stroke AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This data is for internal, Medtronic use only. Data from the study will be analyzed and submitted in the form of abstracts and possible publication in a journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No