Stroke of Known Cause and Underlying Atrial Fibrillation (STROKE-AF) randomized trial: Design and rationale
| Autor: | Robert C. Kowal, Christopher B. Granger, Richard A. Bernstein, Paul D. Ziegler, Hooman Kamel, Lee H. Schwamm |
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| Rok vydání: | 2017 |
| Předmět: |
Male
medicine.medical_specialty Time Factors medicine.medical_treatment Administration Oral Disease 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Risk Factors law Internal medicine Atrial Fibrillation Humans Medicine Prospective Studies cardiovascular diseases Stroke Subclinical infection business.industry Incidence Anticoagulants Atrial fibrillation Middle Aged Prognosis medicine.disease United States Surgery Survival Rate Clinical trial Stroke prevention Electrocardiography Ambulatory Cardiology Female Cardiac monitoring Cardiology and Cardiovascular Medicine business 030217 neurology & neurosurgery Follow-Up Studies |
| Zdroj: | American Heart Journal. 190:19-24 |
| ISSN: | 0002-8703 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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