Stroke, Acute
Conditions
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.
Interventions
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.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms. | 3 years | 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. |
Countries
United States
Participant flow
Pre-assignment details
We enrolled 496 participants in the study but only 492 were randomized. Three participants were enrolled but did not meet eligibility criteria, the fourth withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 240 |
| Control Arm Subjects randomized to the control arm will be followed per site specific standard of care. | 250 |
| Total | 490 |
Baseline characteristics
| Characteristic | Reveal LINQ™ Insertable Cardiac Monitor | Control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 123 Participants | 137 Participants | 260 Participants |
| Age, Categorical Between 18 and 65 years | 117 Participants | 113 Participants | 230 Participants |
| Age, Continuous | 66.6 years STANDARD_DEVIATION 9.3 | 67.5 years STANDARD_DEVIATION 9.5 | 67.1 years STANDARD_DEVIATION 9.4 |
| Congestive Heart Failure | 28 Participants | 23 Participants | 51 Participants |
| Hypertension | 197 Participants | 200 Participants | 397 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 240 participants | 250 participants | 490 participants |
| Sex: Female, Male Female | 96 Participants | 89 Participants | 185 Participants |
| Sex: Female, Male Male | 144 Participants | 161 Participants | 305 Participants |
| Stroke/TIA/Thromboembolism | 240 Participants | 250 Participants | 490 Participants |
| Tobacco Use | 130 Participants | 133 Participants | 263 Participants |
| Vascular Disease | 45 Participants | 47 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 242 | 12 / 250 |
| other Total, other adverse events | 69 / 242 | 45 / 250 |
| serious Total, serious adverse events | 58 / 242 | 65 / 250 |
Outcome results
Primary
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reveal LINQ™ Insertable Cardiac Monitor | The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin. | 12.5 percentage of participants |
| Control Arm | The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin. | 1.8 percentage of participants |
Comparison: H0: h(t) = hT(t) for t ≤ 12 months HA: hC(t) ≠ hT(t) for t ≤ 12 months where hT(t) and hC(t) are the hazard functions of first detected and adjudicated AF at time t for subjects with and without the Reveal LINQ diagnostics for AF, respectively. Hazard functions and survival functions are transformations of each other.p-value: <0.00195% CI: [2.6, 21.3]Log Rank
Secondary
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reveal LINQ™ Insertable Cardiac Monitor | The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms. | 21.7 percentage of participants |
| Control Arm | The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms. | 2.4 percentage of participants |