title: Design and rationale of the ANALYZE ST study: a prospective, nonrandomized, multicenter ST monitoring study to detect acute coronary syndrome events in implantable cardioverter-defibrillator patients.
abstract: BACKGROUND
  In the setting of ST-segment elevation myocardial infarction, timely restoration of normal blood flow is associated with improved myocardial salvage and survival. Despite improvements in door-to-needle and door-to-balloon times, there remains an unmet need with respect to improved symptom-to-door times. A prior report of an implanted device to monitor ST-segment deviation demonstrated very short times to reperfusion among patients with an acute coronary syndrome (ACS) with documented thrombotic occlusion. The goal of the ANALYZE ST study is to evaluate the safety and effectiveness of a novel ST-segment monitoring feature using an existing implantable cardioverter-defibrillator (ICD) among patients with known coronary artery disease.
  
  
  METHODS
  The ANALYZE ST study is a prospective, nonrandomized, multicenter, pivotal Investigational Device Exemption study enrolling 5,228 patients with newly implanted ICD systems for standard clinical indications who also have a documented history of coronary artery disease. Patients will be monitored for 48 months, during which effectiveness of the device for the purpose of early detection of cardiac injury will be evaluated by analyzing the sensitivity of the ST monitoring feature to identify clinical ACS events. In addition, the safety of the ST monitoring feature will be evaluated through the assessment of the percentage of patients for which monitoring produces a false-positive event over the course of 12 months.
  
  
  CONCLUSIONS
  The ANALYZE ST trial is testing the hypothesis that the ST monitoring feature in the Fortify ST ICD system (St. Jude Medical, Inc., St. Paul, MN) (or other ICD systems with the ST monitoring feature) will accurately identify patients with clinical ACS events.
authors.affiliation: Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. Electronic address: mgibson@perfuse.org.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Mitchell
authors.initials: M
authors.lastname: Krucoff
authors.affiliation: Columbia University Medical Center, New York Presbyterian Hospital, New York, NY.
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.affiliation: University Hospitals Case Medical Center, Cleveland, OH.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Mackall
authors.affiliation: University of Southern California, Keck School of Medicine, Los Angeles, CA.
authors.forename: Ray
authors.initials: R
authors.lastname: Matthews
authors.affiliation: Cardiovascular Institute, University of Pittsburg Medical Center, Pittsburg, PA.
authors.forename: Samir
authors.initials: S
authors.lastname: Saba
authors.affiliation: MedStar Washington Hospital Center, Washington, DC.
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.affiliation: Mayo Clinic, Rochester, MN.
authors.forename: David
authors.initials: D
authors.lastname: Holmes
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis* / Q000209:etiology; D001145:Arrhythmias, Cardiac / Q000150:complications / Q000628:therapy*; D017147:Defibrillators, Implantable; D003937:Diagnosis, Differential; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D011379:Prognosis; D011446:Prospective Studies; D013997:Time Factors