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

Primary Purpose

Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reveal LINQ™ Insertable Cardiac Monitor
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke, Acute

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Associates of the Southeast
  • Scripps Memorial Hospital La Jolla
  • University of California San Francisco UCSF Medical Center
  • Innovative Medical Research of South Florida
  • University of Miami Hospital
  • AdventHealth Neuroscience Institute
  • The Queens Medical Center
  • Northwestern University
  • Baptist Health Lexington
  • Norton Neuroscience Institute
  • Ochsner Medical Center
  • Massachusetts General Hospital
  • Health Partners Institute (Bloomington MN)
  • Health Partners Institute (Saint Louis Park MN)
  • Mercy Clinic Cardiology
  • Cox Medical Center South
  • Hackensack University Medical Center
  • Albany Medical Center
  • University at Buffalo, The State University of New York
  • North Shore University Hospital
  • NYU Langone Medical Center
  • Icahn School of Medicine at Mount Sinai
  • Overlook Medical Center
  • Cone Health
  • The University of Oklahoma Health Sciences Center
  • PeaceHealth Sacred Heart Medical Center at Riverbend
  • Lancaster General Hospital
  • Hospital of the University of Pennsylvania
  • Lankenau Institute for Medical Research
  • Saint Thomas Research Institute
  • Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
  • University of Texas (UT) Southwestern Medical Center
  • Houston Methodist Hospital
  • Centra Medical Group Stroobants Cardiovascular Center
  • Aurora Saint Luke's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Reveal LINQ™ Insertable Cardiac Monitor

Control Arm

Arm Description

Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.

Subjects randomized to the control arm will be followed per site specific standard of care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 2, 2016
Last Updated
April 28, 2023
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT02700945
Brief Title
Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
Official Title
Stroke AF - Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized 1:1 to the continuous monitoring arm or the control arm. Subjects randomized to the continuous monitoring arm will have a Reveal LINQ ICM 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
496 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reveal LINQ™ Insertable Cardiac Monitor
Arm Type
Active Comparator
Arm Description
Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Subjects randomized to the control arm will be followed per site specific standard of care.
Intervention Type
Device
Intervention Name(s)
Reveal LINQ™ Insertable Cardiac Monitor
Other Intervention Name(s)
LINQ, LINQ™
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms.
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Bernstein, PhD/MD
Organizational Affiliation
Northwestern
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lee Schwamm, MD
Organizational Affiliation
Mass General
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiovascular Associates of the Southeast
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Scripps Memorial Hospital La Jolla
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California San Francisco UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Innovative Medical Research of South Florida
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
AdventHealth Neuroscience Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
The Queens Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Norton Neuroscience Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Health Partners Institute (Bloomington MN)
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Health Partners Institute (Saint Louis Park MN)
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Mercy Clinic Cardiology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12211
Country
United States
Facility Name
University at Buffalo, The State University of New York
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
North Shore University Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Overlook Medical Center
City
Summit
State/Province
New York
ZIP/Postal Code
07901
Country
United States
Facility Name
Cone Health
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
The University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
PeaceHealth Sacred Heart Medical Center at Riverbend
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Lankenau Institute for Medical Research
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Saint Thomas Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas (UT) Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Centra Medical Group Stroobants Cardiovascular Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
36374508
Citation
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.
Results Reference
derived
PubMed Identifier
35369714
Citation
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.
Results Reference
derived
PubMed Identifier
34061145
Citation
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.
Results Reference
derived

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

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