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

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ClinicalTrials.gov Identifier: NCT00282711
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : August 1, 2012
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Hartford Hospital

Tracking Information
First Submitted Date January 25, 2006
First Posted Date January 27, 2006
Last Update Posted Date August 1, 2012
Study Start Date June 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 16, 2007)
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 ]
Original Primary Outcome Measures
 (submitted: January 25, 2006)
  • 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.
  • To provide objective information for developing guidelines for the evaluation of women at intermediate-high likelihood for CAD.
Change History Complete list of historical versions of study NCT00282711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 16, 2007)
  • To evaluate the differential prognostic accuracy of normal exercise myocardial perfusion Tc-99m tetrofosmin SPECT against a normal exercise ECG. [ Time Frame: 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. [ Time Frame: 2 years ]
  • 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 ]
  • Non-fatal myocardial infarction [ Time Frame: 2 years ]
  • Unstable angina leading to revascularization [ Time Frame: 2 years ]
  • Unstable angina with objective evidence of ischemia requiring hospitalization [ Time Frame: 2 years ]
  • Cardiac death [ Time Frame: 2 years ]
  • Hospitalization for heart failure [ Time Frame: 2 years ]
  • Revascularization [ Time Frame: 2 years ]
  • To provide objective information for developing guidelines for the evaluation of women at intermediate-high likelihood for CAD. [ Time Frame: 2 years ]
  • A cost-effectiveness analysis will be performed comparing the various evaluation strategies. [ Time Frame: 2 years ]
Original Secondary Outcome Measures
 (submitted: January 25, 2006)
  • To evaluate the differential prognostic accuracy of normal exercise myocardial perfusion Tc-99m tetrofosmin SPECT against a normal exercise ECG.
  • 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.
  • Utility of the DASI questionnaire in determining which women are able to achieve predicted maximal heart rate response with treadmill testing
  • Non-fatal myocardial infarction
  • Unstable angina leading to revascularization
  • Unstable angina with objective evidence of ischemia requiring hospitalization
  • Cardiac death
  • Hospitalization for heart failure
  • Revascularization
  • Quality of life measurements
  • Serial measurements will be performed using the Seattle Angina Questionnaire and the DASI questionnaire
  • A cost-effectiveness analysis will be performed comparing the various evaluation strategies.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The WOMEN Study: What is the Optimal Method for Ischemia Evaluation in WomeN?
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"
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Females age 60 and above with suspected heart disease
Condition
  • Coronary Artery Disease
  • Heart Disease
  • Coronary Arteriosclerosis
  • Cardiovascular Disease
  • Myocardial Ischemia
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Standard Exercise treadmill test
  • 2
    Exercise treadmill testing with nuclear imaging
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 31, 2012)
824
Original Enrollment
 (submitted: January 25, 2006)
1008
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00282711
Other Study ID Numbers HELL001524HE
The WOMEN study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hartford Hospital
Study Sponsor Hartford Hospital
Collaborators 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
PRS Account Hartford Hospital
Verification Date July 2012