At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 400 enrolled
Drug / intervention
Perflutren Lipid Microsphere Injectable Suspensiondrug
Likely dose
Perflutren Lipid Microsphere (DEFINITY) 10 mcg/kg by bolus injectionAI-extracted
Key inclusion· 3
- ✓Peri- or post-menopausal women (age 40-65) defined by absence/irregularity of menstrual periods for 6-12 months (peri) or 12+ months (post), or surgical menopause (bilateral salpingo-oophorectomy)
- ✓Asymptomatic with risk factors for heart disease, OR atypical chest pain, OR exertional dyspnea with ≥2 CAD risk factors
- ✓Must be able to perform an exercise stress test
Key exclusion· 1
- ✕Previous confirmed heart disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
SMART: Stress Echocardiography in Menopausal Women at Risk for Coronary Artery Disease Trial
In Brief
A Phase 4 clinical trial evaluating Perflutren Lipid Microsphere Injectable Suspension for Coronary Artery Disease and Heart Disease. Completed, enrolled 400 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Heart Disease
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2004
First PostedSep 2005
Primary CompletionSep 2012
Study CompletionOct 2012
TodayJul 2026
First PostedSep 13, 2005
Enrollment StartApr 1, 2004
Primary CompletionSep 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 20.8 years ago
Interventions
Perflutren Lipid Microsphere Injectable Suspensiondrug
Activated DEFINITY 10ug/kg by bolus injection