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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00282711
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : August 1, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 824 participants
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"
Study Start Date : June 2004
Primary Completion Date : December 2008
Study Completion Date : December 2010
Groups and Cohorts

Group/Cohort
1
Standard Exercise treadmill test
2
Exercise treadmill testing with nuclear imaging


Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To evaluate the differential prognostic accuracy of normal exercise myocardial perfusion Tc-99m tetrofosmin SPECT against a normal exercise ECG. [ Time Frame: 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. [ Time Frame: 2 years ]
  3. 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 ]
  4. Non-fatal myocardial infarction [ Time Frame: 2 years ]
  5. Unstable angina leading to revascularization [ Time Frame: 2 years ]
  6. Unstable angina with objective evidence of ischemia requiring hospitalization [ Time Frame: 2 years ]
  7. Cardiac death [ Time Frame: 2 years ]
  8. Hospitalization for heart failure [ Time Frame: 2 years ]
  9. Revascularization [ Time Frame: 2 years ]
  10. To provide objective information for developing guidelines for the evaluation of women at intermediate-high likelihood for CAD. [ Time Frame: 2 years ]
  11. A cost-effectiveness analysis will be performed comparing the various evaluation strategies. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT00282711     History of Changes
Other Study ID Numbers: HELL001524HE
The WOMEN study
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by Hartford Hospital:
Diagnostic Techniques, Radioisotope
Radionuclide Imaging
Diagnostic Techniques, Cardiovascular
Heart Function tests

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes