Richard A Bernstein1, Hooman Kamel2, Christopher B Granger3, Robert C Kowal4, Paul D Ziegler5, Lee H Schwamm6. 1. Davee Department of Neurology, Feinberg School of Medicine of Northwestern University, Chicago, IL. Electronic address: richard.bernstein4@gmail.com. 2. Department of Neurology, Weill Cornell Medicine, New York, NY. 3. Duke Clinical Research Institute, Duke University Medical Center, Durham, NC. 4. Baylor Heart and Vascular Hospital, Baylor University Medical Center, Dallas, TX. 5. Department of Research, Medtronic Inc., Minneapolis, MN. 6. Stroke Service, Department of Neurology, Massachusetts General Hospital, Boston, MA.
Abstract
BACKGROUND: Approximately 20% of ischemic strokes are associated with clinically apparent atrial fibrillation (AF). Regardless of stroke etiology, detection of AF in patients with ischemic strokes often changes antithrombotic treatment from anti-platelet to oral anticoagulation therapy. The role and the optimum duration of cardiac monitoring to detect AF in patients with strokes presumed due to large vessel atherosclerosis or small vessel disease is unknown. This manuscript describes the design and rationale of the STROKE-AF trial. STUDY DESIGN: STROKE-AF is a randomized, controlled, open-label, post-market clinical trial. Detection of AF will be evaluated using continuous arrhythmia monitoring with an insertable cardiac monitor (ICM) compared with standard of care follow-up in patients with stroke (within the prior 10 days) that is presumed due to large vessel cervical or intracranial atherosclerosis, or to small vessel disease. Approximately 500 patients will be enrolled at approximately 40 centers in the United States. Patients will be randomized 1:1 to arrhythmia monitoring with an ICM (continuous monitoring arm) or standard of care follow-up (control arm). Subjects will be followed for ≥12 months and up to 3 years. OUTCOMES: The primary objective is to compare the incidence rate of detected AF through 12 months of follow-up between the two arms. CONCLUSION: This trial will provide information on the value of ICMs to detect subclinical AF in patients with stroke presumed due to large vessel atherosclerosis or small vessel disease, which will have implications for guiding treatment with oral anticoagulation for secondary stroke prevention.
RCT Entities:
BACKGROUND: Approximately 20% of ischemic strokes are associated with clinically apparent atrial fibrillation (AF). Regardless of stroke etiology, detection of AF in patients with ischemic strokes often changes antithrombotic treatment from anti-platelet to oral anticoagulation therapy. The role and the optimum duration of cardiac monitoring to detect AF in patients with strokes presumed due to large vessel atherosclerosis or small vessel disease is unknown. This manuscript describes the design and rationale of the STROKE-AF trial. STUDY DESIGN:STROKE-AF is a randomized, controlled, open-label, post-market clinical trial. Detection of AF will be evaluated using continuous arrhythmia monitoring with an insertable cardiac monitor (ICM) compared with standard of care follow-up in patients with stroke (within the prior 10 days) that is presumed due to large vessel cervical or intracranial atherosclerosis, or to small vessel disease. Approximately 500 patients will be enrolled at approximately 40 centers in the United States. Patients will be randomized 1:1 to arrhythmia monitoring with an ICM (continuous monitoring arm) or standard of care follow-up (control arm). Subjects will be followed for ≥12 months and up to 3 years. OUTCOMES: The primary objective is to compare the incidence rate of detected AF through 12 months of follow-up between the two arms. CONCLUSION: This trial will provide information on the value of ICMs to detect subclinical AF in patients with stroke presumed due to large vessel atherosclerosis or small vessel disease, which will have implications for guiding treatment with oral anticoagulation for secondary stroke prevention.
Authors: Barbara Dominik; Przemyslaw Mitkowski; Wojciech Zorawski; Ilona Kowalik; Adam Ciesielski Journal: Arch Med Sci Date: 2021-03-25 Impact factor: 3.318