Women's Ischemia Syndrome Evaluation (WISE)

This study has been completed.

Sponsor:

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

ClinicalTrials.gov Identifier:

NCT00000554

First received: October 27, 1999

Last updated: January 15, 2008

Last verified: January 2008

History of Changes

Purpose

To evaluate innovative diagnostic methods that will improve the diagnostic reliability of cardiovascular testing in evaluation of ischemic heart disease in women. Innovative approaches proposed include physiologic or functional measurements such as impaired metabolism, perfusion, or endothelial function as well as assessment of epicardial coronary arteries by angiography. Other objectives include developing safe, accurate, and cost effective diagnostic approaches for evaluating women with suspected ischemic heart disease, and determining the frequency of myocardial ischemia in the absence of significant epicardial coronary stenosis, as well as the frequency of non-ischemic or non-cardiac chest pain. A key aspect of the WISE study is to determine whether evidence of myocardial ischemia occurs in the absence of obstructive coronary disease.

Condition	Intervention	Phase
Angina Pectoris Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia	Procedure: Angiography, MRI, Dobutamine-Stress Echocardiography, PET, Procedure: Myocardial Contrast Echo, Coronary Flow and Vasomotor Testing	Phase 3

Study Type:	Interventional
Study Design:	Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease Heart Diseases

Drug Information available for: Dobutamine Dobutamine hydrochloride

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:	May 2001
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Women over the age of 18 who have suspected ischemic heart disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000554

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:	Sheryl Kelsey	University of Pittsburgh
Investigator:	Carl Pepine	University of Florida
Investigator:	Steven Reis	University of Pittsburgh

More Information

Publications:

Merz CN, Kelsey SF, Pepine CJ, Reichek N, Reis SE, Rogers WJ, Sharaf BL, Sopko G. The Women's Ischemia Syndrome Evaluation (WISE) study: protocol design, methodology and feasibility report. J Am Coll Cardiol. 1999 May;33(6):1453-61.

Reis SE, Holubkov R, Lee JS, Sharaf B, Reichek N, Rogers WJ, Walsh EG, Fuisz AR, Kerensky R, Detre KM, Sopko G, Pepine CJ. Coronary flow velocity response to adenosine characterizes coronary microvascular function in women with chest pain and no obstructive coronary disease. Results from the pilot phase of the Women's Ischemia Syndrome Evaluation (WISE) study. J Am Coll Cardiol. 1999 May;33(6):1469-75.

Lewis JF, Lin L, McGorray S, Pepine CJ, Doyle M, Edmundowicz D, Holubkov R, Pohost G, Reichek N, Rogers W, Sharaf BL, Sopko G, Merz CN. Dobutamine stress echocardiography in women with chest pain. Pilot phase data from the National Heart, Lung and Blood Institute Women's Ischemia Syndrome Evaluation (WISE). J Am Coll Cardiol. 1999 May;33(6):1462-8.

Bittner V, Olson M, Kelsey SF, Rogers WJ, Bairey Merz CN, Armstrong K, Reis SE, Boyette A, Sopko G. Effect of coronary angiography on use of lipid-lowering agents in women: a report from the Women's Ischemia Syndrome Evaluation (WISE) study. For the WISE Investigators. Am J Cardiol. 2000 May 1;85(9):1083-8.

Bairey Merz CN, Olson M, McGorray S, Pakstis DL, Zell K, Rickens CR, Kelsey SF, Bittner V, Sharaf BL, Sopko G. Physical activity and functional capacity measurement in women: a report from the NHLBI-sponsored WISE study. J Womens Health Gend Based Med. 2000 Sep;9(7):769-77.

Olson MB, Kelsey SF, Bittner V, Reis SE, Reichek N, Handberg EM, Merz CN. Weight cycling and high-density lipoprotein cholesterol in women: evidence of an adverse effect: a report from the NHLBI-sponsored WISE study. Women's Ischemia Syndrome Evaluation Study Group. J Am Coll Cardiol. 2000 Nov 1;36(5):1565-71.

Rutledge T, Reis SE, Olson M, Owens J, Kelsey SF, Pepine CJ, Reichek N, Rogers WJ, Merz CN, Sopko G, Cornell CE, Matthews KA. Psychosocial variables are associated with atherosclerosis risk factors among women with chest pain: the WISE study. Psychosom Med. 2001 Mar-Apr;63(2):282-8.

Sharaf BL, Pepine CJ, Kerensky RA, Reis SE, Reichek N, Rogers WJ, Sopko G, Kelsey SF, Holubkov R, Olson M, Miele NJ, Williams DO, Merz CN. Detailed angiographic analysis of women with suspected ischemic chest pain (pilot phase data from the NHLBI-sponsored Women's Ischemia Syndrome Evaluation [WISE] Study Angiographic Core Laboratory). Am J Cardiol. 2001 Apr 15;87(8):937-41; A3.

Reis SE, Holubkov R, Conrad Smith AJ, Kelsey SF, Sharaf BL, Reichek N, Rogers WJ, Merz CN, Sopko G, Pepine CJ. Coronary microvascular dysfunction is highly prevalent in women with chest pain in the absence of coronary artery disease: results from the NHLBI WISE study. Am Heart J. 2001 May;141(5):735-41.

Rutledge T, Reis SE, Olson M, Owens J, Kelsey SF, Pepine CJ, Reichek N, Rogers WJ, Merz CN, Sopko G, Cornell CE, Sharaf B, Matthews KA. History of anxiety disorders is associated with a decreased likelihood of angiographic coronary artery disease in women with chest pain: the WISE study. J Am Coll Cardiol. 2001 Mar 1;37(3):780-5.

Merz NB, Johnson BD, Kelsey PSF, Reis SE, Lewis JF, Reichek N, Rogers WJ, Pepine CF, Shaw LJ. Diagnostic, prognostic, and cost assessment of coronary artery disease in women. Am J Manag Care. 2001 Oct;7(10):959-65.

Wild RA, Reis SE. Estrogens, progestins, selective estrogen receptor modulators, and the arterial tree. Am J Obstet Gynecol. 2001 Apr;184(5):1031-9. Review.

Holubkov R, Karas RH, Pepine CJ, Rickens CR, Reichek N, Rogers WJ, Sharaf BL, Sopko G, Merz CN, Kelsey SF, McGorray SP, Reis SE. Large brachial artery diameter is associated with angiographic coronary artery disease in women. Am Heart J. 2002 May;143(5):802-7.

Reis SE, Olson MB, Fried L, Reeser V, Mankad S, Pepine CJ, Kerensky R, Merz CN, Sharaf BL, Sopko G, Rogers WJ, Holubkov R. Mild renal insufficiency is associated with angiographic coronary artery disease in women. Circulation. 2002 Jun 18;105(24):2826-9.

Bairey Merz CN, Olson MB, Johnson BD, Bittner V, Hodgson TK, Berga SL, Braunstein GD, Pepine CJ, Reis SE, Sopko G, Kelsey SF. Cholesterol-lowering medication, cholesterol level, and reproductive hormones in women: the women's ischemia syndrome evaluation (WISE). Am J Med. 2002 Dec 15;113(9):723-7.

Chen Q, Reis SE, Kammerer CM, McNamara DM, Holubkov R, Sharaf BL, Sopko G, Pauly DF, Merz CN, Kamboh MI. Association between the Severity of Angiographic Coronary Artery Disease and Paraoxonase Gene Polymorphisms in the National Heart, Lung, and Blood Institute-Sponsored Women's Ischemia Syndrome Evaluation (WISE) Study. Am J Hum Genet. 2003 Jan;72(1):13-22.

Bairey Merz CN, Johnson BD, Sharaf BL, Bittner V, Berga SL, Braunstein GD, Hodgson TK, Matthews KA, Pepine CJ, Reis SE, Reichek N, Rogers WJ, Pohost GM, Kelsey SF, Sopko G. Hypoestrogenemia of hypothalamic origin and coronary artery disease in premenopausal women: a report from the NHLBI-sponsored WISE study. J Am Coll Cardiol. 2003 Feb 5;41(3):413-9.

Rutledge T, Reis SE, Olson M, Owens J, Kelsey SF, Pepine CJ, Reichek N, Rogers WJ, Bairey-Merz CN, Sopko G, Cornell CE, Matthews KA. Socioeconomic status variables predict cardiovascular disease risk factors and prospective mortality risk among women with chest pain. The WISE Study. Behav Modif. 2003 Jan;27(1):54-67.

Marroquin OC, Holubkov R, Edmundowicz D, Rickens C, Pohost G, Buchthal S, Pepine CJ, Sopko G, Sembrat RC, Meltzer CC, Reis SE. Heterogeneity of microvascular dysfunction in women with chest pain not attributable to coronary artery disease: implications for clinical practice. Am Heart J. 2003 Apr;145(4):628-35.

Holubkov R, Pepine CJ, Rickens C, Reichek N, Rogers WJ, Sharaf BL, Sopko G, Merz CN, Kelsey SF, Olson M, Smith KM, Reis SE. Electrocardiogram abnormalities predict angiographic coronary artery disease in women with chest pain: results from the NHLBI WISE Study. Clin Cardiol. 2002 Dec;25(12):553-8.

Chen Q, Reis SE, Kammerer CM, McNamara DM, Holubkov R, Sharaf BL, Sopko G, Pauly DF, Bairey Merz CN, Kamboh MI. APOE polymorphism and angiographic coronary artery disease severity in the Women's Ischemia Syndrome Evaluation (WISE) study. Atherosclerosis. 2003 Jul;169(1):159-67.

Chen Q, Reis SE, Kammerer C, Craig WY, LaPierre SE, Zimmer EL, McNamara DM, Pauly DF, Sharaf B, Holubkov R, Bairey Merz CN, Sopko G, Bontempo F, Kamboh MI. Genetic variation in lectin-like oxidized low-density lipoprotein receptor 1 (LOX1) gene and the risk of coronary artery disease. Circulation. 2003 Jul 1;107(25):3146-51. Epub 2003 Jun 16.

Johnson BD, Kip KE, Marroquin OC, Ridker PM, Kelsey SF, Shaw LJ, Pepine CJ, Sharaf B, Bairey Merz CN, Sopko G, Olson MB, Reis SE; National Heart, Lung, and Blood Institute. Serum amyloid A as a predictor of coronary artery disease and cardiovascular outcome in women: the National Heart, Lung, and Blood Institute-Sponsored Women's Ischemia Syndrome Evaluation (WISE). Circulation. 2004 Feb 17;109(6):726-32.

Marroquin OC, Kip KE, Kelley DE, Johnson BD, Shaw LJ, Bairey Merz CN, Sharaf BL, Pepine CJ, Sopko G, Reis SE; Women's Ischemia Syndrome Evaluation Investigators. Metabolic syndrome modifies the cardiovascular risk associated with angiographic coronary artery disease in women: a report from the Women's Ischemia Syndrome Evaluation. Circulation. 2004 Feb 17;109(6):714-21.

Kip KE, Marroquin OC, Kelley DE, Johnson BD, Kelsey SF, Shaw LJ, Rogers WJ, Reis SE. Clinical importance of obesity versus the metabolic syndrome in cardiovascular risk in women: a report from the Women's Ischemia Syndrome Evaluation (WISE) study. Circulation. 2004 Feb 17;109(6):706-13.

von Mering GO, Arant CB, Wessel TR, McGorray SP, Bairey Merz CN, Sharaf BL, Smith KM, Olson MB, Johnson BD, Sopko G, Handberg E, Pepine CJ, Kerensky RA; National Heart, Lung, and Blood Institute. Abnormal coronary vasomotion as a prognostic indicator of cardiovascular events in women: results from the National Heart, Lung, and Blood Institute-Sponsored Women's Ischemia Syndrome Evaluation (WISE). Circulation. 2004 Feb 17;109(6):722-5.

Olson MB, Bairey Merz CN, Shaw LJ, Mankad S, Reis SE, Pohost GM, Smith KM, McGorray SP, Cornell CE, Kelsey SF; NHLBI-Sponsored WISE Study. Hormone replacement, race, and psychological health in women: a report from the NHLBI-Sponsored WISE Study. J Womens Health (Larchmt). 2004 Apr;13(3):325-32.

Arant CB, Wessel TR, Olson MB, Bairey Merz CN, Sopko G, Rogers WJ, Sharaf BL, Reis SE, Smith KM, Johnson BD, Handberg E, Mankad S, Pepine CJ; National Heart, Lung, and Blood Institute Women's Ischemia Syndrome Evaluation Study. Hemoglobin level is an independent predictor for adverse cardiovascular outcomes in women undergoing evaluation for chest pain: results from the National Heart, Lung, and Blood Institute Women's Ischemia Syndrome Evaluation Study. J Am Coll Cardiol. 2004 Jun 2;43(11):2009-14.

Johnson BD, Shaw LJ, Buchthal SD, Bairey Merz CN, Kim HW, Scott KN, Doyle M, Olson MB, Pepine CJ, den Hollander J, Sharaf B, Rogers WJ, Mankad S, Forder JR, Kelsey SF, Pohost GM; National Institutes of Health-National Heart, Lung, and Blood Institute. Prognosis in women with myocardial ischemia in the absence of obstructive coronary disease: results from the National Institutes of Health-National Heart, Lung, and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation (WISE). Circulation. 2004 Jun 22;109(24):2993-9. Epub 2004 Jun 14.

Wessel TR, Arant CB, Olson MB, Johnson BD, Reis SE, Sharaf BL, Shaw LJ, Handberg E, Sopko G, Kelsey SF, Pepine CJ, Merz NB. Relationship of physical fitness vs body mass index with coronary artery disease and cardiovascular events in women. JAMA. 2004 Sep 8;292(10):1179-87.

Rutledge T, Reis SE, Olson M, Owens J, Kelsey SF, Pepine CJ, Mankad S, Rogers WJ, Bairey Merz CN, Sopko G, Cornell CE, Sharaf B, Matthews KA; National Heart, Lung, and Blood Institute. Social networks are associated with lower mortality rates among women with suspected coronary disease: the National Heart, Lung, and Blood Institute-Sponsored Women's Ischemia Syndrome Evaluation study. Psychosom Med. 2004 Nov-Dec;66(6):882-8.

Morise AP, Olson MB, Merz CN, Mankad S, Rogers WJ, Pepine CJ, Reis SE, Sharaf BL, Sopko G, Smith K, Pohost GM, Shaw L. Validation of the accuracy of pretest and exercise test scores in women with a low prevalence of coronary disease: the NHLBI-sponsored Women's Ischemia Syndrome Evaluation (WISE) study. Am Heart J. 2004 Jun;147(6):1085-92.

Johnson BD, Merz CN, Braunstein GD, Berga SL, Bittner V, Hodgson TK, Gierach GL, Reis SE, Vido DA, Sharaf BL, Smith KM, Sopko G, Kelsey SF. Determination of menopausal status in women: the NHLBI-sponsored Women's Ischemia Syndrome Evaluation (WISE) Study. J Womens Health (Larchmt). 2004 Oct;13(8):872-87.

Lewis JF, McGorray S, Lin L, Pepine CJ, Chaitman B, Doyle M, Edmundowicz D, Sharaf BL, Merz CN; National Heart, Lung and Blood Institute. Exercise treadmill testing using a modified exercise protocol in women with suspected myocardial ischemia: findings from the National Heart, Lung and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation (WISE). Am Heart J. 2005 Mar;149(3):527-33.

Triola B, Olson MB, Reis SE, Rautaharju P, Merz CN, Kelsey SF, Shaw LJ, Sharaf BL, Sopko G, Saba S. Electrocardiographic Predictors of Cardiovascular Outcome in Women The National Heart, Lung, and Blood Institute-Sponsored Women's Ischemia Syndrome Evaluation (WISE) Study. J Am Coll Cardiol. 2005 Jul 5;46(1):51-6.

Olson MB, Krantz DS, Kelsey SF, Pepine CJ, Sopko G, Handberg E, Rogers WJ, Gierach GL, McClure CK, Merz CN; WISE Study Group. Hostility scores are associated with increased risk of cardiovascular events in women undergoing coronary angiography: a report from the NHLBI-Sponsored WISE Study. Psychosom Med. 2005 Jul-Aug;67(4):546-52.

Terra SG, McGorray SP, Wu R, McNamara DM, Cavallari LH, Walker JR, Wallace MR, Johnson BD, Bairey Merz CN, Sopko G, Pepine CJ, Johnson JA. Association between beta-adrenergic receptor polymorphisms and their G-protein-coupled receptors with body mass index and obesity in women: a report from the NHLBI-sponsored WISE study. Int J Obes (Lond). 2005 Jul;29(7):746-54.

Kip KE, Marroquin OC, Shaw LJ, Arant CB, Wessel TR, Olson MB, Johnson BD, Mulukutla S, Sopko G, Merz CN, Reis SE. Global inflammation predicts cardiovascular risk in women: a report from the Women's Ischemia Syndrome Evaluation (WISE) study. Am Heart J. 2005 Nov;150(5):900-6.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pepine CJ, Anderson RD, Sharaf BL, Reis SE, Smith KM, Handberg EM, Johnson BD, Sopko G, Bairey Merz CN. Coronary microvascular reactivity to adenosine predicts adverse outcome in women evaluated for suspected ischemia results from the National Heart, Lung and Blood Institute WISE (Women's Ischemia Syndrome Evaluation) study. J Am Coll Cardiol. 2010 Jun 22;55(25):2825-32.

Pacanowski MA, Zineh I, Li H, Johnson BD, Cooper-DeHoff RM, Bittner V, McNamara DM, Sharaf BL, Merz CN, Pepine CJ, Johnson JA. Adrenergic gene polymorphisms and cardiovascular risk in the NHLBI-sponsored Women's Ischemia Syndrome Evaluation. J Transl Med. 2008 Mar 10;6:11.

ClinicalTrials.gov Identifier:	NCT00000554 History of Changes
Other Study ID Numbers:	98
Study First Received:	October 27, 1999
Last Updated:	January 15, 2008
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Angina Pectoris
Cardiovascular Diseases
Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Heart Diseases
Ischemia
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Dobutamine

Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on June 13, 2013

To Top