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

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00282711
First received: January 25, 2006
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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
Coronary Artery Disease
Heart Disease
Coronary Arteriosclerosis
Cardiovascular Disease
Myocardial Ischemia

Study Type: Observational
Study Design: 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"

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the differential prognostic accuracy of normal exercise myocardial perfusion Tc-99m tetrofosmin SPECT against a normal exercise ECG. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Non-fatal myocardial infarction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Unstable angina leading to revascularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Unstable angina with objective evidence of ischemia requiring hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cardiac death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Hospitalization for heart failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Revascularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To provide objective information for developing guidelines for the evaluation of women at intermediate-high likelihood for CAD. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • A cost-effectiveness analysis will be performed comparing the various evaluation strategies. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 824
Study Start Date: June 2004
Study Completion Date: December 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Standard Exercise treadmill test
2
Exercise treadmill testing with nuclear imaging

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:

Additional 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
Study First Received: January 25, 2006
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014