AzTrials
AzTrials

Coronary Artery DiseaseNCT00282711

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

An observational study of Coronary Artery Disease and Heart Disease, run by Hartford Hospital at 43 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older, women only
How many people
824 participants
Where
43 sitesin 2 countries
Study dates
Jun 2004to Dec 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Females age 60 and above with suspected heart disease

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

United States41 sites

  • Albany Associates in Cardiology

    Albany, New York, 12212

  • Cardiology Consultants of Orange Country Medical Group, Inc

    Anaheim, California, 92801

  • Cardiac Disease Specialists

    Atlanta, Georgia, 30309

  • Androscoggin Cardiology Associates

    Auburn, Maine, 04210

  • Fox Valley Cardiovascular Consultants

    Aurora, Illinois, 60504

  • Blue Stem Cardiology

    Bartlesville, Oklahoma, 74006

  • Idaho Cardiology Associates

    Boise, Idaho, 83704

  • Brooklyn Nuclear SPECT Imaging

    Brooklyn, New York, 11235

  • Medical University of SC (MUSC)

    Charleston, South Carolina, 29466

  • Heart Place

    Dallas, Texas, 75226

  • Iowa Heart Center

    Des Moines, Iowa, 50314

  • Escondido Cardiology Associates

    Escondido, California, 92025

  • Saint Francis Hospital of Evanston

    Evanston, Illinois, 60202

  • Florida Heart Associates

    Fort Meyers, Florida, 33907

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Pentucket Medical Associates

    Haverhill, Massachusetts, 01830

  • Diagnostic Cardiology, PA

    Jacksonville, Florida, 32216

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Jacksonville Heart Center, PA

    Jacksonville, Florida, 32250

  • Jacksonville Heart Center, PA

    Jacksonville Beach, Florida, 32250

  • Cardiovascular Consultants, PC

    Kansas City, Missouri, 64111

  • Mid-Valley Cardiology

    Kingston, New York, 12401

  • Condell Medical Center

    Libertyville, Illinois, 60048

  • Cardiovascular Associates

    Louisville, Kentucky, 40205

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Idaho Cardiology Associates

    Meridian, Idaho, 83704

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • Mission Internal Medical Group

    Mission Viejo, California, 92691

  • Delaware SPECT Imaging

    Newark, Delaware, 19713

  • St. Joseph's Hospital Women's Hrt Cnt

    Orange, California, 92868

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania, 19146

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania, 19148

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Sacramento Heart & Vascular Res. Ctr.

    Sacramento, California, 95825

  • San Diego Cardiac Center

    San Diego, California, 92123

  • Cardiovascular Consultants of Maine, PA

    Scarborough, Maine, 04074

  • Deaconess Medical Center

    Spokane, Washington, 99204

  • Heart and Vascular Institute of Florida

    St. Petersburg, Florida, 33701

  • Southwest Heart

    Tucson, Arizona, 85715

  • Cardiology Associates of Northern Mississippi

    Tupelo, Mississippi, 38801

  • Cardiovascular Consultants

    Walnut Creek, California, 94598

Other trials in United States

Canada2 sites

  • Sudbury Regional Hospital

    Greater Sudbury, Ontario, P3E 6C3

  • Univ. of Ottawa Heart Insitute

    Ottawa, Ontario, K1Y4W7

Other trials in Canada

About this study

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"

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.

Read the detailed description

Coronary artery disease remains the leading cause of morbidity and mortality in women accounting for more than 250,000 deaths per year. While mortality rates have decreased significantly in men during the last several decades, there has been little change for women. Furthermore, despite the high prevalence of ischemic heart disease (IHD) in women, most clinical trials have focused on male cohorts, resulting in a lack of data for women. Their exclusion from clinical trials has been primarily due to the following: 1) child- bearing potential, 2) beyond the arbitrary age limits established for trials, 3) frequent concomitant or advanced disease, and 4) inhomogeneity within the study population.

Extrapolation of the published clinical trial data (predominately obtained in men) for women is controversial due to differences in epidemiology of heart disease in women. Treatment is often sought later in life and is usually accompanied by more advanced disease and co-morbidities, which therefore, impact survival. In addition, women more frequently have an absence of clinical symptoms or an atypical presentation, making the diagnosis of coronary artery disease (CAD) challenging. Furthermore, women may also have their first manifestation of CAD as sudden death or acute myocardial infarction. Therefore, there is a clear need for the early identification of IHD in women so that treatments may be employed prior to having an advanced state of disease and higher risk for unfavorable outcomes.

The optimal non-invasive test for evaluation of IHD in women is unknown. A number of different modalities have been employed including exercise ECG stress testing, 2-dimensional stress echocardiography, single photon emission computerized tomography (SPECT) myocardial perfusion imaging, and electron beam tomography. Additionally, the cohort of women for whom testing is performed is also ill defined.

The most recent AHA/ACC guidelines suggest that ECG stress testing should be the preferred approach. Supportive data for this recommendation are controversial, as many of the studies examining the diagnostic value of ECG stress testing were largely performed in small cohorts of women and are dated. These trials indicate that the diagnostic accuracy of stress testing is only fair (sensitivity=32-89%; specificity=41-68%). A recent meta-analysis in 3,874 women demonstrated modest sensitivity and specificity, 62% and 69% respectively, even after adjustment for referral bias (8). Published guidelines have also included a meta-analysis and confirmed a low level (sensitivity=33%) of detection of disease. Additionally, the high rate of false positives, as well as the inability to fully ascertain the extent of disease, therefore limits the potential value of ECG stress testing.

Even though exercise stress testing is supported by recent clinical guidelines, the addition of SPECT myocardial perfusion imaging has independent and incremental diagnostic and prognostic value. Improved diagnostic accuracy has also been noted with perfusion imaging and its ability to predict cardiac events in women is well established. Furthermore, recent data supports the cost-effectiveness of strategies that employ myocardial perfusion imaging in the assessment of women at risk for ICD.

The current AHA/ACC recommendations fail to take into account that women often have limited ability to complete maximal exercise, a problem that is likely due to their older age and more frequent co-morbidities as compared with men. This functional impairment may lead to a lack of ischemia provocation and/or indeterminate exercise testing results. Maximal predicted heart rate, oxygen consumption, and, more commonly, metabolic equivalents (METs) are measures to estimate physical work capacity. The Duke Activity Status Index (DASI) is a simple 12-item questionnaire that estimates peak oxygen consumption. The Duke Activity Status Index (DASI) questionnaire may identify patients who are likely to perform inadequate exercise, which amounts to nearly 40% of all women referred for exercise testing.

The optimal strategy for the evaluation of women with suspected ischemic heart disease is unknown and quite controversial. Several algorithms have been suggested for the evaluation of women with suspected CAD. A recent consensus paper from the American Society of Nuclear Cardiology suggested a strategy that employed perfusion imaging, but provided little evidence to support such a clinical strategy, such as with a prospective clinical trial. The focus of this investigation is to compare different strategies for the assessment of women at intermediate or high clinical risk for IHD and to do so on a prospective, randomized basis. This study is therefore focused on providing a high level of clinical evidence on which to base future recommendations and guidelines for the care of women with heart disease.

Keywords
Diagnostic Techniques, Radioisotope, Radionuclide Imaging, Diagnostic Techniques, Cardiovascular, Heart Function tests
Medical subject headings
Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00282711
Study groupRoleWhat they receive
1Standard Exercise treadmill test
2Exercise treadmill testing with nuclear imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (11)

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

    Measured: 2 years

  2. 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.

    Measured: 2 years

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

    Measured: 2 years

  4. Non-fatal myocardial infarction

    Measured: 2 years

  5. Unstable angina leading to revascularization

    Measured: 2 years

  6. Unstable angina with objective evidence of ischemia requiring hospitalization

    Measured: 2 years

  7. Cardiac death

    Measured: 2 years

  8. Hospitalization for heart failure

    Measured: 2 years

  9. Revascularization

    Measured: 2 years

  10. To provide objective information for developing guidelines for the evaluation of women at intermediate-high likelihood for CAD.

    Measured: 2 years

  11. A cost-effectiveness analysis will be performed comparing the various evaluation strategies.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2006 (estimated)
  2. Study startJun 2004
  3. Primary completionDec 2008
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
824 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00282711
Sponsor's protocol ID
HELL001524HE
Other IDs
The WOMEN study
Status last verified
Jul 2012
First submitted
25 Jan 2006
Last updated
1 Aug 2012
Results posted
No
Data monitoring committee
Yes

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

    PubMed 12569338

  • 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.

    PubMed 8116993

  • 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.

    PubMed 10318674

  • 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.

    PubMed 8733082

  • 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.

    PubMed 9236456

  • 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.

    PubMed 6741986

  • 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.

    PubMed 10080415

  • 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.

    PubMed 9278880

  • 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.

    PubMed 9591568

  • 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.

    PubMed 8752792

  • 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.

    PubMed 9420775

  • 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.

    PubMed 11854122

  • 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.

    PubMed 11448403

  • 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.

    PubMed 12571200

  • 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.

    PubMed 10230746

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Heart Disease, run by Hartford Hospital at 43 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00282711, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in