title: The risk of paradoxical embolism (RoPE) study: initial description of the completed database.
abstract: BACKGROUND
  Detecting a benefit from closure of patent foramen ovale in patients with cryptogenic stroke is hampered by low rates of stroke recurrence and uncertainty about the causal role of patent foramen ovale in the index event. A method to predict patent foramen ovale-attributable recurrence risk is needed. However, individual databases generally have too few stroke recurrences to support risk modeling. Prior studies of this population have been limited by low statistical power for examining factors related to recurrence.
  
  
  OBJECTIVE
  The aim of this study was to develop a database to support modeling of patent foramen ovale-attributable recurrence risk by combining extant data sets.
  
  
  METHODS
  We identified investigators with extant databases including subjects with cryptogenic stroke investigated for patent foramen ovale, determined the availability and characteristics of data in each database, collaboratively specified the variables to be included in the Risk of Paradoxical Embolism database, harmonized the variables across databases, and collected new primary data when necessary and feasible.
  
  
  RESULTS
  The Risk of Paradoxical Embolism database has individual clinical, radiologic, and echocardiographic data from 12 component databases, including subjects with cryptogenic stroke both with (n = 1925) and without (n = 1749) patent foramen ovale. In the patent foramen ovale subjects, a total of 381 outcomes (stroke, transient ischemic attack, death) occurred (median follow-up 2·2 years). While there were substantial variations in data collection between studies, there was sufficient overlap to define a common set of variables suitable for risk modeling.
  
  
  CONCLUSIONS
  While individual studies are inadequate for modeling patent foramen ovale-attributable recurrence risk, collaboration between investigators has yielded a database with sufficient power to identify those patients at highest risk for a patent foramen ovale-related stroke recurrence who may have the greatest potential benefit from patent foramen ovale closure.
authors.affiliation: Department of Neurology, Tufts Medical Center/Tufts University School of Medicine, Boston, MA, USA.
authors.forename: David E
authors.initials: DE
authors.lastname: Thaler
authors.forename: Emanuele
authors.initials: E
authors.lastname: Di Angelantonio
authors.forename: Marco R
authors.initials: MR
authors.lastname: Di Tullio
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Donovan
authors.forename: John
authors.initials: J
authors.lastname: Griffith
authors.forename: Shunichi
authors.initials: S
authors.lastname: Homma
authors.forename: Cheryl
authors.initials: C
authors.lastname: Jaigobin
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Mas
authors.forename: Heinrich P
authors.initials: HP
authors.lastname: Mattle
authors.forename: Patrik
authors.initials: P
authors.lastname: Michel
authors.forename: Marie-Luise
authors.initials: ML
authors.lastname: Mono
authors.forename: Krassen
authors.initials: K
authors.lastname: Nedeltchev
authors.forename: Federica
authors.initials: F
authors.lastname: Papetti
authors.forename: Robin
authors.initials: R
authors.lastname: Ruthazer
authors.forename: Joaquín
authors.initials: J
authors.lastname: Serena
authors.forename: Christian
authors.initials: C
authors.lastname: Weimar
authors.forename: Mitchell S V
authors.initials: MS
authors.lastname: Elkind
authors.forename: David M
authors.initials: DM
authors.lastname: Kent
mesh_terms: D000328:Adult; D000368:Aged; D019992:Databases as Topic; D019320:Embolism, Paradoxical / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications* / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D008962:Models, Theoretical; D012008:Recurrence; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology / Q000209:etiology