The WOMEN Study: What is the Optimal Method for Ischemia Evaluation in WomeN? - Full Text View

Purpose

The purpose of this study is to compare two types of exercise stress testing to find the best method for detecting heart disease in women.

Condition
Coronary Artery Disease Heart Disease Coronary Arteriosclerosis Cardiovascular Disease Myocardial Ischemia

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The WOMEN Study: What is the Optimal Method for Ischemia Evaluation in WomeN?"A Multi-Center, Prospective, Randomized Study to Establish the Optimal Method for Detection of CAD Risk in Women at an Intermediate-High Pre-Test Likelihood CAD"

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Exercise and Physical Fitness Heart Diseases

U.S. FDA Resources

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:

To compare 2-year event rates for women capable of performing exercise treadmill testing with normal myocardial perfusion SPECT using Tc-99m tetrofosmin as compared with a negative stress ECG. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the differential prognostic accuracy of normal exercise myocardial perfusion Tc-99m tetrofosmin SPECT against a normal exercise ECG. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To compare the diagnostic sensitivity and specificity of exercise ECG versus exercise ECG-gated Tc-99m tetrofosmin SPECT myocardial perfusion imaging in women who undergo an elective cardiac catheterization. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Utility of the DASI questionnaire in determining which women are able to achieve predicted maximal heart rate response with treadmill testing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Non-fatal myocardial infarction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Unstable angina leading to revascularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Unstable angina with objective evidence of ischemia requiring hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Cardiac death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Hospitalization for heart failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Revascularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To provide objective information for developing guidelines for the evaluation of women at intermediate-high likelihood for CAD. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
A cost-effectiveness analysis will be performed comparing the various evaluation strategies. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	824
Study Start Date:	June 2004
Study Completion Date:	December 2010
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Standard Exercise treadmill test
2 Exercise treadmill testing with nuclear imaging

Show Detailed Description

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Females age 60 and above with suspected heart disease

Criteria

Inclusion Criteria:

- Women 60 years of age and older presenting for the evaluation of chest pain, or other anginal equivalent symptoms while at an intermediate-high pretest risk for IHD

Exclusion Criteria:

Women with known CAD
Women scoring <5 METs on the DASI
Nursing or pregnant females
Nuclear medicine study within the preceding 10 days
Electrocardiographic abnormalities precluding interpretation of peak stress changes including: Left bundle branch block, electronic ventricular pacemaker, left ventricular hypertrophy, WPW, and resting ST-T wave changes. Additionally, patients currently on digoxin therapy
Significant valvular heart disease (i.e. severe aortic stenosis or regurgitation, or severe mitral insufficiency)
Hemodynamic instability (blood pressure >210/110 ml/Hg or <90/60 mm/Hg)
Left ventricular systolic dysfunction with a left ventricular ejection fraction less than 30 %
Unavailability for long-term follow-up

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282711

Show 43 Study Locations

Sponsors and Collaborators

Hartford Hospital

GE Healthcare

Investigators

Principal Investigator:	Gary V. Heller, M.D., Ph.D.	Hartford Hospital, Hartford, CT
Principal Investigator:	Robert C. Hendel, M.D.	Rush University Medical Center, Chicago, IL
Principal Investigator:	Jennifer H. Mieres, M.D.	North SHore University Hospital, Long Island, NY
Principal Investigator:	Leslie J. Shaw, Ph.D.	Atlanta Cardiovascular Research Institute, Atlanta, GA

More Information

Additional Information:

ACC/AHA 2002 guideline update for exercise testing: a report of the American College of Cardiology/American Heart Association task Force on Practice Guidelines (Committee of Exercise Testing) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Mieres JH, Shaw LJ, Hendel RC, Miller DD, Bonow RO, Berman DS, Heller GV, Mieres JH, Bairey-Merz CN, Berman DS, Bonow RO, Cacciabaudo JM, Heller GV, Hendel RC, Kiess MC, Miller DD, Polk DM, Shaw LJ, Smanio PE, Walsh MN; Writing Group on Perfusion Imaging in Women. American Society of Nuclear Cardiology consensus statement: Task Force on Women and Coronary Artery Disease--the role of myocardial perfusion imaging in the clinical evaluation of coronary artery disease in women [correction]. J Nucl Cardiol. 2003 Jan-Feb;10(1):95-101. Review. No abstract available. Erratum in: J Nucl Cardiol. 2003 Mar-Apr;10(2):218.

Shaw LJ, Miller DD, Romeis JC, Kargl D, Younis LT, Chaitman BR. Gender differences in the noninvasive evaluation and management of patients with suspected coronary artery disease. Ann Intern Med. 1994 Apr 1;120(7):559-66.

Mosca L, Grundy SM, Judelson D, King K, Limacher M, Oparil S, Pasternak R, Pearson TA, Redberg RF, Smith SC Jr, Winston M, Zinberg S. Guide to Preventive Cardiology for Women.AHA/ACC Scientific Statement Consensus panel statement. Circulation. 1999 May 11;99(18):2480-4. Review. No abstract available.

Holdright DR, Fox KM. Characterization and identification of women with angina pectoris. Eur Heart J. 1996 Apr;17(4):510-7. Review. No abstract available. Erratum in: Eur Heart J 1996 Sep;17(9):1452.

Gibbons RJ, Balady GJ, Beasley JW, Bricker JT, Duvernoy WF, Froelicher VF, Mark DB, Marwick TH, McCallister BD, Thompson PD, Winters WL Jr, Yanowitz FG, Ritchie JL, Cheitlin MD, Eagle KA, Gardner TJ, Garson A Jr, Lewis RP, O'Rourke RA, Ryan TJ. ACC/AHA guidelines for exercise testing: executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing). Circulation. 1997 Jul 1;96(1):345-54. No abstract available.

Hlatky MA, Pryor DB, Harrell FE Jr, Califf RM, Mark DB, Rosati RA. Factors affecting sensitivity and specificity of exercise electrocardiography. Multivariable analysis. Am J Med. 1984 Jul;77(1):64-71.

Kwok Y, Kim C, Grady D, Segal M, Redberg R. Meta-analysis of exercise testing to detect coronary artery disease in women. Am J Cardiol. 1999 Mar 1;83(5):660-6.

Iskandrian AE, Heo J, Nallamothu N. Detection of coronary artery disease in women with use of stress single-photon emission computed tomography myocardial perfusion imaging. J Nucl Cardiol. 1997 Jul-Aug;4(4):329-35. Review. No abstract available.

Santana-Boado C, Candell-Riera J, Castell-Conesa J, Aguade-Bruix S, Garcia-Burillo A, Canela T, Gonzalez JM, Cortadellas J, Ortega D, Soler-Soler J. Diagnostic accuracy of technetium-99m-MIBI myocardial SPECT in women and men. J Nucl Med. 1998 May;39(5):751-5.

Hachamovitch R, Berman DS, Kiat H, Bairey CN, Cohen I, Cabico A, Friedman J, Germano G, Van Train KF, Diamond GA. Effective risk stratification using exercise myocardial perfusion SPECT in women: gender-related differences in prognostic nuclear testing. J Am Coll Cardiol. 1996 Jul;28(1):34-44.

Pancholy SB, Fattah AA, Kamal AM, Ghods M, Heo J, Iskandrian AS. Independent and incremental prognostic value of exercise thallium single-photon emission computed tomographic imaging in women. J Nucl Cardiol. 1995 Mar-Apr;2(2 Pt 1):110-6.

Hachamovitch R, Berman DS, Kiat H, Cohen I, Friedman JD, Shaw LJ. Value of stress myocardial perfusion single photon emission computed tomography in patients with normal resting electrocardiograms: an evaluation of incremental prognostic value and cost-effectiveness. Circulation. 2002 Feb 19;105(7):823-9.

Galassi AR, Azzarelli S, Tomaselli A, Giosofatto R, Ragusa A, Musumeci S, Tamburino C, Giuffrida G. Incremental prognostic value of technetium-99m-tetrofosmin exercise myocardial perfusion imaging for predicting outcomes in patients with suspected or known coronary artery disease. Am J Cardiol. 2001 Jul 15;88(2):101-6.

Shaw LJ, Hendel R, Borges-Neto S, Lauer MS, Alazraki N, Burnette J, Krawczynska E, Cerqueira M, Maddahi J; Myoview Multicenter Registry. Prognostic value of normal exercise and adenosine (99m)Tc-tetrofosmin SPECT imaging: results from the multicenter registry of 4,728 patients. J Nucl Med. 2003 Feb;44(2):134-9. Erratum in: J Nucl Med. 2003 Apr;44(4):648.

Marwick TH, Shaw LJ, Lauer MS, Kesler K, Hachamovitch R, Heller GV, Travin MI, Borges-Neto S, Berman DS, Miller DD. The noninvasive prediction of cardiac mortality in men and women with known or suspected coronary artery disease. Economics of Noninvasive Diagnosis (END) Study Group. Am J Med. 1999 Feb;106(2):172-8.

Shaw LJ, Heller GV, Travin MI, Lauer M, Marwick T, Hachamovitch R, Berman DS, Miller DD. Cost analysis of diagnostic testing for coronary artery disease in women with stable chest pain. Economics of Noninvasive Diagnosis (END) Study Group. J Nucl Cardiol. 1999 Nov-Dec;6(6):559-69.

Gibbons RJ, Chatterjee K, Daley J, Douglas JS, Fihn SD, Gardin JM, Grunwald MA, Levy D, Lytle BW, O'Rourke RA, Schafer WP, Williams SV. ACC/AHA/ACP-ASIM guidelines for the management of patients with chronic stable angina: executive summary and recommendations. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients with Chronic Stable Angina). Circulation. 1999 Jun 1;99(21):2829-48. No abstract available.

Diamond GA, Forrester JS. Analysis of probability as an aid in the clinical diagnosis of coronary-artery disease. N Engl J Med. 1979 Jun 14;300(24):1350-8.

Chaitman BR, Bourassa MG, Davis K, Rogers WJ, Tyras DH, Berger R, Kennedy JW, Fisher L, Judkins MP, Mock MB, Killip T. Angiographic prevalence of high-risk coronary artery disease in patient subsets (CASS). Circulation. 1981 Aug;64(2):360-7.

Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC Jr; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). ACC/AHA 2002 guideline update for exercise testing: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). Circulation. 2002 Oct 1;106(14):1883-92. No abstract available.

Cerqueira MD, Weissman NJ, Dilsizian V, Jacobs AK, Kaul S, Laskey WK, Pennell DJ, Rumberger JA, Ryan T, Verani MS; American Heart Association Writing Group on Myocardial Segmentation and Registration for Cardiac Imaging. Standardized myocardial segmentation and nomenclature for tomographic imaging of the heart: a statement for healthcare professionals from the Cardiac Imaging Committee of the Council on Clinical Cardiology of the American Heart Association. Circulation. 2002 Jan 29;105(4):539-42. Review. No abstract available.

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

Shaw LJ, Mieres JH, Hendel RH, Boden WE, Gulati M, Veledar E, Hachamovitch R, Arrighi JA, Merz CN, Gibbons RJ, Wenger NK, Heller GV; WOMEN Trial Investigators. Comparative Effectiveness of exercise electrocardiography with or without myocardial perfusion single photon emission computed tomography in women with suspected coronary artery disease: results from the What Is the Optimal Method for Ischemia Evaluation in Women (WOMEN) trial. Circulation. 2011 Sep 13;124(11):1239-49. Epub 2011 Aug 15.

Responsible Party:	Hartford Hospital
ClinicalTrials.gov Identifier:	NCT00282711 History of Changes
Other Study ID Numbers:	HELL001524HE, The WOMEN study
Study First Received:	January 25, 2006
Last Updated:	July 31, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hartford Hospital:

Diagnostic Techniques, Radioisotope
Radionuclide Imaging
Diagnostic Techniques, Cardiovascular
Heart Function tests

Additional relevant MeSH terms:

Arteriosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease

Heart Diseases
Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013