NCT00162370

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Lantheus Medical Imaging · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The clinical trial is designed to determine the prognostic value of stress echocardiography as a screening examination in peri-, or post-menopausal female patients with an intermediate likelihood of coronary artery disease (CAD) based on risk factors to identify patients at higher risk of experiencing future cardiac events.Female patients who are able to adequately exercise will undergo a symptom-limited exercise echocardiogram. Patients who are unable to adequately exercise or are predicted to be unable to exercise adequately (because of orthopedic/neurologic limitations, lung disease or debility), will perform dobutamine stress echocardiography. All patients will receive DEFINITY at rest and stress to enhance wall motion assessment.

Conditions

• Coronary Artery Disease
• Heart Disease

Interventions

Type	Name	Description
DRUG	Perflutren Lipid Microsphere Injectable Suspension	Activated DEFINITY 10ug/kg by bolus injection

Timeline

• Start date: 2004-04-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2005-09-13
• Last updated: 2021-03-15
• Results posted: 2016-12-08

Locations

3 sites across 1 country: United States