The WOMEN Study: What is the Optimal Method for Ischemia Evaluation in WomeN?

NCT00282711 | Completed DMC

• 2 other identifiers: HELL001524HEThe WOMEN study
• Study Type: observational
• Target: 824
• Locations: 2 countries
• Sites: 43

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (11)

• To evaluate the differential prognostic accuracy of normal exercise myocardial perfusion Tc-99m tetrofosmin SPECT against a normal exercise ECG.

  2 years

• 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.

  2 years

• Utility of the DASI questionnaire in determining which women are able to achieve predicted maximal heart rate response with treadmill testing

  2 years

• Non-fatal myocardial infarction

  2 years

• Unstable angina leading to revascularization

  2 years

Study Arms (2)

1

Standard Exercise treadmill test

2

Exercise treadmill testing with nuclear imaging

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Females age 60 and above with suspected heart disease

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• GE Healthcare: collaborator

Study Sites (43)

Southwest Heart

Tucson, Arizona, 85715, United States

Location

Cardiology Consultants of Orange Country Medical Group, Inc

Anaheim, California, 92801, United States

Location

Escondido Cardiology Associates

Escondido, California, 92025, United States

Location

Mission Internal Medical Group

Mission Viejo, California, 92691, United States

Location

St. Joseph's Hospital Women's Hrt Cnt

Orange, California, 92868, United States

Location

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

Sacramento Heart & Vascular Res. Ctr.

Sacramento, California, 95825, United States

Location

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

Cardiovascular Consultants

Walnut Creek, California, 94598, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

Delaware SPECT Imaging

Newark, Delaware, 19713, United States

Location

Florida Heart Associates

Fort Meyers, Florida, 33907, United States

Location

Diagnostic Cardiology, PA

Jacksonville, Florida, 32216, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Jacksonville Heart Center, PA

Jacksonville, Florida, 32250, United States

Location

Jacksonville Heart Center, PA

Jacksonville Beach, Florida, 32250, United States

Location

Heart and Vascular Institute of Florida

St. Petersburg, Florida, 33701, United States

Location

Cardiac Disease Specialists

Atlanta, Georgia, 30309, United States

Location

Idaho Cardiology Associates

Boise, Idaho, 83704, United States

Location

Idaho Cardiology Associates

Meridian, Idaho, 83704, United States

Location

Fox Valley Cardiovascular Consultants

Aurora, Illinois, 60504, United States

Location

Saint Francis Hospital of Evanston

Evanston, Illinois, 60202, United States

Location

Condell Medical Center

Libertyville, Illinois, 60048, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50314, United States

Location

Cardiovascular Associates

Louisville, Kentucky, 40205, United States

Location

Clinical Trials Management, LLC

Metairie, Louisiana, 70006, United States

Location

Androscoggin Cardiology Associates

Auburn, Maine, 04210, United States

Location

Cardiovascular Consultants of Maine, PA

Scarborough, Maine, 04074, United States

Location

Pentucket Medical Associates

Haverhill, Massachusetts, 01830, United States

Location

Cardiology Associates of Northern Mississippi

Tupelo, Mississippi, 38801, United States

Location

Cardiovascular Consultants, PC

Kansas City, Missouri, 64111, United States

Location

Albany Associates in Cardiology

Albany, New York, 12212, United States

Location

Brooklyn Nuclear SPECT Imaging

Brooklyn, New York, 11235, United States

Location

Mid-Valley Cardiology

Kingston, New York, 12401, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Blue Stem Cardiology

Bartlesville, Oklahoma, 74006, United States

Location

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, 19148, United States

Location

Medical University of SC (MUSC)

Charleston, South Carolina, 29466, United States

Location

Heart Place

Dallas, Texas, 75226, United States

Location

Deaconess Medical Center

Spokane, Washington, 99204, United States

Location

Sudbury Regional Hospital

Greater Sudbury, Ontario, P3E 6C3, Canada

Location

Univ. of Ottawa Heart Insitute

Ottawa, Ontario, K1Y4W7, Canada

Location

Related Publications (22)

• 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. doi: 10.1067/mnc.2003.130362. No abstract available.

  PMID: 12569338 BACKGROUND

• 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. doi: 10.7326/0003-4819-120-7-199404010-00005.

  PMID: 8116993 BACKGROUND

• 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. doi: 10.1161/01.cir.99.18.2480. No abstract available.

  PMID: 10318674 BACKGROUND

• Holdright DR, Fox KM. Characterization and identification of women with angina pectoris. Eur Heart J. 1996 Apr;17(4):510-7. doi: 10.1093/oxfordjournals.eurheartj.a014902. No abstract available.

  PMID: 8733082 BACKGROUND

• 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. doi: 10.1161/01.cir.96.1.345. No abstract available.

  PMID: 9236456 BACKGROUND

• 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. doi: 10.1016/0002-9343(84)90437-6.

  PMID: 6741986 BACKGROUND

• 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. doi: 10.1016/s0002-9149(98)00963-1.

  PMID: 10080415 BACKGROUND

• 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. doi: 10.1016/s1071-3581(97)90111-2. No abstract available.

  PMID: 9278880 BACKGROUND

• 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.

  PMID: 9591568 BACKGROUND

• 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. doi: 10.1016/0735-1097(96)00095-2.

  PMID: 8752792 BACKGROUND

• 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. doi: 10.1016/s1071-3581(95)80021-2.

  PMID: 9420775 BACKGROUND

• 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. doi: 10.1161/hc0702.103973.

  PMID: 11854122 BACKGROUND

• 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. doi: 10.1016/s0002-9149(01)01601-0.

  PMID: 11448403 BACKGROUND

• 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.

  PMID: 12571200 BACKGROUND

• 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. doi: 10.1016/s0002-9343(98)00388-x.

  PMID: 10230746 BACKGROUND

• 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. doi: 10.1016/s1071-3581(99)90091-0.

  PMID: 10608582 BACKGROUND

• 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. doi: 10.1161/01.cir.99.21.2829. No abstract available.

  PMID: 10351980 BACKGROUND

• 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. doi: 10.1056/NEJM197906143002402.

  PMID: 440357 BACKGROUND

• 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. doi: 10.1161/01.cir.64.2.360.

  PMID: 7249303 BACKGROUND

• 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). 2002 American College of Cardiology website. Available at www.acc.org/clinical/guidelines/exercise/dirlndex.htm

  BACKGROUND

• 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. doi: 10.1161/hc0402.102975. No abstract available.

  PMID: 11815441 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.111.029660. Epub 2011 Aug 15.

  PMID: 21844080 DERIVED

Related Links

• 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)

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2006
• First Posted: January 27, 2006
• Study Start: June 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2010
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (41); CA (2)