N/A
N=492
Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
Stroke, Acute
Bottom Line
View on ClinicalTrials.gov: NCT02700945 ↗Enrolled (actual)
492
Serious AEs
25.0%
Results posted
Nov 2021
Primary outcome: Primary: The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin. — 12.5; 1.8 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reveal LINQ™ Insertable Cardiac Monitor (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin. |
12.5; 1.8 | <0.001 sig |
| SECONDARY The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms. |
21.7; 2.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02700945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.