A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease - Full Text View

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 Artery Disease Heart Disease in Women Heart Diseases Menopause Stress

ChemIDplus related topics:

Octafluoropropane Lipids

U.S. FDA Resources

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 as provided by Lantheus Medical Imaging:

Primary Outcome Measures:

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 Outcome Measures:

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.

Estimated Enrollment:	500
Study Start Date:	April 2004
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	48 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162370

Locations


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

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

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

Sponsors and Collaborators

Lantheus Medical Imaging

Investigators


Principal Investigator:	Sharon Mulvagh, MD	Mayo Clinic

More Information

Study ID Numbers:	Definity-407
First Received:	September 9, 2005
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00162370
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Arterial Occlusive Diseases

Coronary Disease

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Stress

Arteriosclerosis

Ischemia

Menopause

Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Lantheus Medical Imaging
Information provided by:	Lantheus Medical Imaging
ClinicalTrials.gov Identifier:	NCT00162370