title: The Women's Ischemia Syndrome Evaluation (WISE) study: protocol design, methodology and feasibility report.
abstract: OBJECTIVE
  The Women's Ischemia Syndrome Evaluation (WISE) is a National Heart, Lung and Blood Institute-sponsored, four-center study designed to: 1) optimize symptom evaluation and diagnostic testing for ischemic heart disease; 2) explore mechanisms for symptoms and myocardial ischemia in the absence of epicardial coronary artery stenoses, and 3) evaluate the influence of reproductive hormones on symptoms and diagnostic test response.
  
  
  BACKGROUND
  Accurate diagnosis of ischemic heart disease in women is a major challenge to physicians, and the role reproductive hormones play in this diagnostic uncertainty is unexplored. Moreover, the significance and pathophysiology of ischemia in the absence of significant epicardial coronary stenoses is unknown.
  
  
  METHODS
  The WISE common core data include demographic and clinical data, symptom and psychosocial variables, coronary angiographic and ventriculographic data, brachial artery reactivity testing, resting/ambulatory electrocardiographic monitoring and a variety of blood determinations. Site-specific complementary methods include physiologic and functional cardiovascular assessments of myocardial perfusion and metabolism, ventriculography, endothelial vascular function and coronary angiography. Women are followed for at least 1 year to assess clinical events and symptom status.
  
  
  RESULTS
  In Phase I (1996-1997), a pilot phase, 256 women were studied. These data indicate that the WISE protocol is safe and feasible for identifying symptomatic women with and without significant epicardial coronary artery stenoses.
  
  
  CONCLUSIONS
  The WISE study will define contemporary diagnostic testing to evaluate women with suspected ischemic heart disease. Phase II (1997-1999) is ongoing and will study an additional 680 women, for a total WISE enrollment of 936 women. Phase III (2000) will include patient follow-up, data analysis and a National Institutes of Health WISE workshop.
authors.affiliation: Department of Medicine, Cedars-Sinai Research Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
authors.forename: C N
authors.initials: CN
authors.lastname: Merz
authors.forename: S F
authors.initials: SF
authors.lastname: Kelsey
authors.forename: C J
authors.initials: CJ
authors.lastname: Pepine
authors.forename: N
authors.initials: N
authors.lastname: Reichek
authors.forename: S E
authors.initials: SE
authors.lastname: Reis
authors.forename: W J
authors.initials: WJ
authors.lastname: Rogers
authors.forename: B L
authors.initials: BL
authors.lastname: Sharaf
authors.forename: G
authors.initials: G
authors.lastname: Sopko
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D017023:Coronary Angiography; D003327:Coronary Disease / Q000175:diagnosis* / Q000503:physiopathology; D005240:Feasibility Studies; D005260:Female; D012739:Gonadal Steroid Hormones / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000175:diagnosis* / Q000503:physiopathology; D012107:Research Design; D012307:Risk Factors
chemical_list: D012739:Gonadal Steroid Hormones