Clinical Trial: A Phase 4 Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease.

This study is currently recruiting patients.
Verified by Bristol-Myers Squibb September 2005

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00162370

Purpose

The study is designed to see if stress echocardiography can be used as a screening exam in peri-, or post-menopausal women with a risk of developing of coronary artery disease and experiencing future cardiac events.
Condition Intervention Phase
Coronary Artery Disease
Heart Disease
 Drug: Perflutren Lipid Microsphere Injectable Suspension
Phase IV

MedlinePlus related topics:  Coronary Disease;   Heart Diseases

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title: SMART: Stress Echocardiography in Menopausal Women at Risk for Coronary Artery Disease Trial

Further Study Details: 
Primary Outcomes: Determine the prognostic value of stress echocardiography as a screening exam in peri- or; post menopausal women with an intermediate pre-test likelihood of coronary artery disease; to identify patients at higher risk of experiencing future cardiac events.
Secondary Outcomes: Evaluate the prognostic value of exercise ECG testing for identifying patients with cardiac events during follow-up.; Determine the value of exercise induced changes in levels of cardiac peptides (atrial natriuretic peptide and brain natriuretic peptide) in identifying patients with cardiac events during follow-up.; Determine the value of brachial artery reactivity for identifying patients with cardiac events during follow-up.; Determine the relative values of exercise echocardiography, exercise ECG testing, cardiac peptides and brachial artery reactivity for identifying patients at risk of cardiac events.; Determine the cost-effectiveness of using stress echocardiography in screening peri- and post-menopausal women at intermediate risk for coronary artery disease.
Expected Total Enrollment:  500

Study start: April 2004

Eligibility

Ages Eligible for Study:  48 Years   -   60 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

  • Peri or Post menopausal women without symptoms and having risk factors for heart disease or experiencing atypical chest pain
  • Must be able to perform an exercise stress test

Exclusion Criteria:

  • Previous confirmed heart disease

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00162370

BMS Call Center      1-866-892-1BMS  Ext. 202 

Arizona
      Local Institution, Scottsdale,  Arizona,  85259,  United States; Recruiting

Florida
      Local Institution, Jacksonville,  Florida,  32224,  United States; Recruiting

Minnesota
      Local Institution, Rochester,  Minnesota,  55905,  United States; Recruiting

Study chairs or principal investigators

Martin Rosenberg, MD,  Study Director,  Bristol Myers Squibb Medical Imaging   

More Information

Study ID Numbers:  Definity-407
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00162370
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13

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