Women's Ischemia Syndrome Evaluation (WISE)

NCT ID: NCT00000554

Last Updated: 2014-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2007-04-30

Brief Summary

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.

Detailed Description

BACKGROUND:

Cardiovascular disease exacts a heavy burden on the health of women. Ischemic heart disease claims the lives of nearly 250,000 women in the United States each year. Recognition of ischemic heart disease in women is a major challenge to the primary care physician. Diagnosis of ischemic heart disease requires recognition of clinical symptoms such as chest pain, or events such as a myocardial infarction, which are evaluated by a physician who will confirm the diagnosis with objective tests. Unfortunately, both symptom recognition and diagnostic tests confuse rather than confirm a diagnosis of myocardial ischemia in women. Chest pain syndromes suspicious for myocardial ischemia are common in women. Noninvasive diagnostic methods which often confirm the diagnosis and assess disease severity in men are less reliable in women. This lack of objective data to support the diagnosis of chronic or acute myocardial ischemia may influence the physician's decision to further evaluate women at risk. With precision in diagnosis, efforts to optimize therapies are hampered.

The detection of epicardial coronary atherosclerosis is a major objective in clinical cardiology. The utility of this approach is well established. However, although the presence of atherosclerosis is sufficient to cause myocardial ischemia, whether significant ischemia or risk of ischemia exists in the absence of angiographic epicardial stenosis, is not known and may be important for women.

Recent progress in understanding the pathophysiology of myocardial ischemia provides a more complex causal pathway than the heretofore notion of fixed atherosclerotic obstructions in passive conduits. Diseased arteries which may appear angiographically normal as well as arteries with fixed obstructions can respond to vasomotor influences with a detrimental amount of vasoconstriction. The endothelium generates vasoactive and anticoagulant factors that are important mediators of thrombosis. Cycling hormones may further influence these complex interactions. Methods which do not rely solely on fixed obstruction of epicardial arteries are not only possible but may be useful to recognize early atherosclerosis or, for example, endothelial dysfunction which places the patient at risk for untoward coronary events.

The concept for the study was developed by the Cardiology Advisory Committee in collaboration with staff and was approved by the May 1993 National Heart, Lung, and Blood Advisory Council. The Request for Proposals was released in April 1994.

DESIGN NARRATIVE:

The Women's Ischemia Syndrome Evaluation (WISE) was a four center study designed to evaluate ischemic heart disease and its pathophysiology in women. WISE testing focused on three areas: 1) optimizing symptom evaluation and diagnostic testing for ischemic heart disease; 2) exploring mechanisms for symptoms and evidence of myocardial ischemia in the absence of epicardial coronary artery disease; 3) evaluating the influence of reproductive hormones on symptoms and diagnostic test response. The WISE core data base included demographic and clinical data, symptom and psychosocial variables, coronary angiography and ventriculography data, blood lipoprotein/homocysteine/lipid peroxidation/genetic/hormone/ phytoestrogen analysis, brachial artery reactivity testing, and resting/ambulatory electrocardiographic (ECG) monitoring. Site specific complementary methods included physiologic and functional cardiovascular assessments of myocardial perfusion and metabolism, ventriculography, endothelial vascular function and coronary angiography. Women were followed for at least one year to assess clinical events and symptom status. In the Phase I (1996-7), a pilot phase, 256 women were studied. Phase II has completed enrolling 1008 women in the study. The WISE study defined contemporary and comprehensive state-of-the-art diagnostic testing to evaluate women with suspected ischemic heart disease, and explore sex specific ischemic heart disease pathophysiology.

The study has been renewed through April, 2005 to extend patient follow-up for a minimum of five years. Dr. Kelsey (U01HL64829) of the Data Coordinating Center at the University of Pittsburgh will continue the follow-up, develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables, assess cost effectiveness of the WISE testing techniques, and continue data analyses. Dr. Reis (U01HL64914) will study the immunologic basis of coronary disease in women, focusing on the role of inflammation and cytokine production. He will measure several cytokines and cytokine-related proteins and genotypes in approximately 900 stored samples from WISE participants. Dr. Pepine (U01HL64924) will study the renin angiotensin system in coronary microvascular dysfunction, focusing on whether polymorphisms of the renin-angiotensin/kallikrein-kinin systems and beta-adrenergic receptors polymorphisms are associated with abnormal coronary microvascular function determined by coronary flow reserve measurements.

Conditions

Angina Pectoris; Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia

Study Design

• Primary Study Purpose: DIAGNOSTIC

Interventions

Angiography, MRI, Dobutamine-Stress Echocardiography, PET,

Intervention Type: PROCEDURE

Myocardial Contrast Echo, Coronary Flow and Vasomotor Testing

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheryl Kelsey

Role:

University of Pittsburgh

Carl Pepine

Role:

University of Florida

Steven Reis

Role:

University of Pittsburgh

References

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

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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. doi: 10.1067/mhj.2002.121735.

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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. doi: 10.1161/01.cir.0000021597.63026.65.

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Bairey Merz CN, Olson MB, Johnson BD, Bittner V, Hodgson TK, Berga SL, Braunstein GD, Pepine CJ, Reis SE, Sopko G, Kelsey SF; Women's Ischemia Syndrome Evaluation. 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. doi: 10.1016/s0002-9343(02)01366-9.

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Chen Q, Reis SE, Kammerer CM, McNamara DM, Holubkov R, Sharaf BL, Sopko G, Pauly DF, Merz CN, Kamboh MI; WISE Study Group. 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. doi: 10.1086/345312. Epub 2002 Nov 26.

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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; WISE Study Group. 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. doi: 10.1016/s0735-1097(02)02763-8.

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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. doi: 10.1177/0145445502238693.

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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. doi: 10.1067/mhj.2003.95.

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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. doi: 10.1161/01.CIR.0000115516.54550.B1.

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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. doi: 10.1161/01.CIR.0000115517.26897.A7.

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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. doi: 10.1161/01.CIR.0000115514.44135.A8.

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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. doi: 10.1001/jama.292.10.1179.

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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. doi: 10.1089/jwh.2004.13.872.

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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. doi: 10.1097/01.psy.0000170830.99263.4e.

Reference Type: BACKGROUND

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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. doi: 10.1038/sj.ijo.0802978.

Reference Type: BACKGROUND

PMID: 15917856 (View on PubMed)

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. doi: 10.1016/j.ahj.2005.02.002.

Reference Type: BACKGROUND

PMID: 16290958 (View on PubMed)

Wu S, Wei J, Lauzon M, Suppogu N, Kelsey SF, Reis SE, Shaw LJ, Sopko G, Handberg E, Pepine CJ, Bairey Merz CN. Left ventricular ejection fraction and long-term outcomes in women presenting with signs and symptoms of ischaemia. Heart. 2023 Oct 12;109(21):1624-1630. doi: 10.1136/heartjnl-2023-322494.

Reference Type: DERIVED

PMID: 37316162 (View on PubMed)

Quesada O, Lauzon M, Buttle R, Wei J, Suppogu N, Cook-Wiens G, Reis SE, Shaw LJ, Sopko G, Handberg E, Pepine CJ, Noel Bairey Merz C. Fitness attenuates long-term cardiovascular outcomes in women with ischemic heart disease and metabolic syndrome. Am J Prev Cardiol. 2023 Apr 23;14:100498. doi: 10.1016/j.ajpc.2023.100498. eCollection 2023 Jun.

Reference Type: DERIVED

PMID: 37181803 (View on PubMed)

Barsky L, Shufelt C, Lauzon M, Johnson BD, Berga SL, Braunstein G, Bittner V, Shaw L, Reis S, Handberg E, Pepine CJ, Bairey Merz CN. Prior Oral Contraceptive Use and Longer Term Mortality Outcomes in Women with Suspected Ischemic Heart Disease. J Womens Health (Larchmt). 2021 Mar;30(3):377-384. doi: 10.1089/jwh.2020.8743. Epub 2021 Jan 21.

Reference Type: DERIVED

PMID: 33481672 (View on PubMed)

Lee JJ, Cook-Wiens G, Johnson BD, Braunstein GD, Berga SL, Stanczyk FZ, Pepine CJ, Bairey Merz CN, Shufelt CL. Age at Menarche and Risk of Cardiovascular Disease Outcomes: Findings From the National Heart Lung and Blood Institute-Sponsored Women's Ischemia Syndrome Evaluation. J Am Heart Assoc. 2019 Jun 18;8(12):e012406. doi: 10.1161/JAHA.119.012406. Epub 2019 Jun 5.

Reference Type: DERIVED

PMID: 31165670 (View on PubMed)

AlBadri A, Bairey Merz CN, Johnson BD, Wei J, Mehta PK, Cook-Wiens G, Reis SE, Kelsey SF, Bittner V, Sopko G, Shaw LJ, Pepine CJ, Ahmed B. Impact of Abnormal Coronary Reactivity on Long-Term Clinical Outcomes in Women. J Am Coll Cardiol. 2019 Feb 19;73(6):684-693. doi: 10.1016/j.jacc.2018.11.040.

Reference Type: DERIVED

PMID: 30765035 (View on PubMed)

Mohandas R, Segal M, Srinivas TR, Johnson BD, Wen X, Handberg EM, Petersen JW, Sopko G, Merz CN, Pepine CJ. Mild renal dysfunction and long-term adverse outcomes in women with chest pain: results from the National Heart, Lung, and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation (WISE). Am Heart J. 2015 Mar;169(3):412-8. doi: 10.1016/j.ahj.2014.12.010. Epub 2015 Jan 6.

Reference Type: DERIVED

PMID: 25728732 (View on PubMed)

Fontana V, McDonough CW, Gong Y, El Rouby NM, Sa AC, Taylor KD, Chen YD, Gums JG, Chapman AB, Turner ST, Pepine CJ, Johnson JA, Cooper-DeHoff RM. Large-scale gene-centric analysis identifies polymorphisms for resistant hypertension. J Am Heart Assoc. 2014 Nov 10;3(6):e001398. doi: 10.1161/JAHA.114.001398.

Reference Type: DERIVED

PMID: 25385345 (View on PubMed)

Sharaf B, Wood T, Shaw L, Johnson BD, Kelsey S, Anderson RD, Pepine CJ, Bairey Merz CN. Adverse outcomes among women presenting with signs and symptoms of ischemia and no obstructive coronary artery disease: findings from the National Heart, Lung, and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation (WISE) angiographic core laboratory. Am Heart J. 2013 Jul;166(1):134-41. doi: 10.1016/j.ahj.2013.04.002. Epub 2013 May 2.

Reference Type: DERIVED

PMID: 23816032 (View on PubMed)

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. doi: 10.1016/j.jacc.2010.01.054.

Reference Type: DERIVED

PMID: 20579539 (View on PubMed)

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. doi: 10.1186/1479-5876-6-11.

Reference Type: DERIVED

PMID: 18331634 (View on PubMed)

Other Identifiers

U01HL064829

Identifier Type: NIH

Identifier Source: secondary_id

View Link

98

Identifier Type: -

Identifier Source: org_study_id