Stroke, AcuteNCT02700945

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

A study testing Reveal LINQ™ Insertable Cardiac Monitor in people with Stroke, Acute, run by Medtronic Cardiac Rhythm and Heart Failure at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Stroke, Acute
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: 496 participants
Where: 35 sitesUnited States
Study dates: Mar 2016to 28 Jul 2022
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Stroke, Acute
Being tested: Reveal LINQ™ Insertable Cardiac Monitor
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reveal LINQ™ Insertable Cardiac MonitorDevice
Also called LINQ, LINQ™
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.

Study groups in NCT02700945
Study group	Role	What they receive
Reveal LINQ™ Insertable Cardiac Monitor	Active comparator	Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device. Receives: Device: Reveal LINQ™ Insertable Cardiac Monitor
Control Arm	No intervention	Subjects randomized to the control arm will be followed per site specific standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (1)

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.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201628 Jul 2022

First posted7 Mar 2016 (estimated)
Study startMar 2016
Primary completion3 Aug 2020
Study completion28 Jul 2022

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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Stroke, AcuteStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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: Randomised
Intervention model: Parallel groups
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)
Enrolment: 496 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02700945
Sponsor's protocol ID: Stroke AF
Status last verified: Apr 2023
First submitted: 2 Mar 2016
Last updated: 26 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: 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.

Publications

Bernstein RA, Kamel H, Granger CB, Piccini JP, Katz JM, Sethi PP, Pouliot E, Franco N, Ziegler PD, Schwamm LH; STROKE AF Investigators. Atrial Fibrillation In Patients With Stroke Attributed to Large- or Small-Vessel Disease: 3-Year Results From the STROKE AF Randomized Clinical Trial. JAMA Neurol. 2023 Dec 1;80(12):1277-1283. doi: 10.1001/jamaneurol.2023.3931.
PubMed 37902733
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.
PubMed 36374508
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.
PubMed 35369714
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.
PubMed 34061145

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stroke AF - Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
ClinicalTrials.gov ID: NCT02700945
Acronym / sponsor ID: Stroke AF
Conditions: Stroke, Acute
Study type: Interventional
Recruitment status: Completed
Enrolment: 496 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Mar 2016 (actual)
Primary completion: 3 Aug 2020 (actual)
Study completion: 28 Jul 2022 (actual)
First posted: 7 Mar 2016 (estimated)
Results: Posted 9 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Reveal LINQ™ Insertable Cardiac Monitor	Active comparator	Device: Reveal LINQ™ Insertable Cardiac MonitorSubjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.
Control Arm	No intervention	–Subjects randomized to the control arm will be followed per site specific standard of care.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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:

Key exclusion criteria (15 listed)

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

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 MonitorAlso: LINQ, LINQ™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.	Device	Reveal LINQ™ Insertable Cardiac Monitor

Primary outcome

The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin.
Time frame: 12 months
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.

1 secondary outcome

The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms.
Time frame: 3 years

Results and safety

Results posted to the registry on 9 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reveal LINQ™ Insertable Cardiac Monitor	242	210
Control Arm	250	207

Primary outcome: The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin.

Time frame: 12 months. Number. Unit: percentage of participants

Measure	Reveal LINQ™ Insertable Cardiac Monitor n = 242	Control Arm n = 250
Value	12.5	1.8

Reveal LINQ™ Insertable Cardiac Monitor vs Control Arm: Hazard Ratio (HR): 7.4 (95% CI 2.6 to 21.3), p <0.001, Log Rank

1 secondary outcome is reported in the full results.

Adverse events

Time frame: We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reveal LINQ™ Insertable Cardiac Monitor	58 of 242 (24%)	69 of 242 (28.5%)	5 of 242
Control Arm	65 of 250 (26%)	45 of 250 (18%)	12 of 250

Limitations and caveats (from the sponsor): The attribution of stroke mechanism is subjective and may have led to the enrollment of a population at higher risk of underlying embolism. However, this attribution reflects real-world practice and our sample is representative of patients in whom ICM decisions need to be made. The assignment to ICM versus control was not blinded, however our study endpoint was adjudicated using objective criteria. Our study was not powered to detect a significant difference in rates of recurrent stroke.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37902733Bernstein RA, Kamel H, Granger CB, Piccini JP, Katz JM, Sethi PP, Pouliot E, Franco N, Ziegler PD, Schwamm LH; STROKE AF Investigators. Atrial Fibrillation In Patients With Stroke Attributed to Large- or Small-Vessel Disease: 3-Year Results From the STROKE AF Randomized Clinical Trial. JAMA Neurol. 2023 Dec 1;80(12):1277-1283. doi: 10.1001/jamaneurol.2023.3931.
Derived from this study: PubMed 36374508Schwamm 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.
Derived from this study: PubMed 35369714Zachrison 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.
Derived from this study: PubMed 34061145Bernstein 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.
Individual participant dataSharing planned: No. 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.

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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.

Richard Bernstein, PhD/MD study chair

Northwestern University

Lee Schwamm, MD study chair

Mass General

35 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 Stroke, Acute, run by Medtronic Cardiac Rhythm and Heart Failure at 35 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 15 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 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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 9 Nov 2021). 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?

The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02700945, which also lists 4 linked publications.

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 26 May 2023.