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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

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

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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
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2010

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



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 ]


Information from the National Library of Medicine

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

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


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Locations
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United States, Arizona
Southwest Heart
Tucson, Arizona, United States, 85715
United States, California
Cardiology Consultants of Orange Country Medical Group, Inc
Anaheim, California, United States, 92801
Escondido Cardiology Associates
Escondido, California, United States, 92025
Mission Internal Medical Group
Mission Viejo, California, United States, 92691
St. Joseph's Hospital Women's Hrt Cnt
Orange, California, United States, 92868
Sutter Roseville Medical Center
Roseville, California, United States, 95661
Sacramento Heart & Vascular Res. Ctr.
Sacramento, California, United States, 95825
San Diego Cardiac Center
San Diego, California, United States, 92123
Cardiovascular Consultants
Walnut Creek, California, United States, 94598
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, Delaware
Delaware SPECT Imaging
Newark, Delaware, United States, 19713
United States, Florida
Florida Heart Associates
Fort Meyers, Florida, United States, 33907
Jacksonville Heart Center, PA
Jacksonville Beach, Florida, United States, 32250
Diagnostic Cardiology, PA
Jacksonville, Florida, United States, 32216
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Jacksonville Heart Center, PA
Jacksonville, Florida, United States, 32250
Heart and Vascular Institute of Florida
St Petersburg, Florida, United States, 33701
United States, Georgia
Cardiac Disease Specialists
Atlanta, Georgia, United States, 30309
United States, Idaho
Idaho Cardiology Associates
Boise, Idaho, United States, 83704
Idaho Cardiology Associates
Meridian, Idaho, United States, 83704
United States, Illinois
Fox Valley Cardiovascular Consultants
Aurora, Illinois, United States, 60504
Saint Francis Hospital of Evanston
Evanston, Illinois, United States, 60202
Condell Medical Center
Libertyville, Illinois, United States, 60048
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50314
United States, Kentucky
Cardiovascular Associates
Louisville, Kentucky, United States, 40205
United States, Louisiana
Clinical Trials Management, LLC
Metairie, Louisiana, United States, 70006
United States, Maine
Androscoggin Cardiology Associates
Auburn, Maine, United States, 04210
Cardiovascular Consultants of Maine, PA
Scarborough, Maine, United States, 04074
United States, Massachusetts
Pentucket Medical Associates
Haverhill, Massachusetts, United States, 01830
United States, Mississippi
Cardiology Associates of Northern Mississippi
Tupelo, Mississippi, United States, 38801
United States, Missouri
Cardiovascular Consultants, PC
Kansas City, Missouri, United States, 64111
United States, New York
Albany Associates in Cardiology
Albany, New York, United States, 12212
Brooklyn Nuclear SPECT Imaging
Brooklyn, New York, United States, 11235
Mid-Valley Cardiology
Kingston, New York, United States, 12401
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, Oklahoma
Blue Stem Cardiology
Bartlesville, Oklahoma, United States, 74006
United States, Pennsylvania
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, United States, 19146
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, United States, 19148
United States, South Carolina
Medical University of SC (MUSC)
Charleston, South Carolina, United States, 29466
United States, Texas
Heart Place
Dallas, Texas, United States, 75226
United States, Washington
Deaconess Medical Center
Spokane, Washington, United States, 99204
Canada, Ontario
Univ. of Ottawa Heart Insitute
Ottawa, Ontario, Canada, K1Y4W7
Sudbury Regional Hospital
Sudbury, Ontario, Canada, P3E 6C3
Sponsors and Collaborators
Hartford Hospital
GE Healthcare
Investigators
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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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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:
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Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Ischemia
Cardiovascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes