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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00162370
First received: September 9, 2005
Last updated: May 5, 2014
Last verified: May 2014

September 9, 2005
May 5, 2014
April 2004
September 2012   (final data collection date for primary outcome measure)
  • Determine the prognostic value of stress echocardiography as a screening exam in peri- or [ Time Frame: 2 and 5 year follow up ] [ Designated as safety issue: No ]
  • post menopausal women with an intermediate pre-test likelihood of coronary artery disease [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • to identify patients at higher risk of experiencing future cardiac events. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • 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.
Complete list of historical versions of study NCT00162370 on ClinicalTrials.gov Archive Site
  • Evaluate the prognostic value of exercise ECG testing for identifying patients with cardiac events during follow-up. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Determine the value of brachial artery reactivity for identifying patients with cardiac events during follow-up. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Determine the relative values of exercise echocardiography, exercise ECG testing, cardiac peptides and brachial artery reactivity for identifying patients at risk of cardiac events. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Determine the cost-effectiveness of using stress echocardiography in screening peri- and post-menopausal women at intermediate risk for coronary artery disease. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Coronary Artery Disease
  • Heart Disease
Drug: Perflutren Lipid Microsphere Injectable Suspension
Activated DEFINITY 10ug/kg by bolus injection
Other Name: DEFINITY
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
October 2012
September 2012   (final data collection date for primary outcome measure)

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
Female
48 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00162370
DMP 115-407
No
Lantheus Medical Imaging
Lantheus Medical Imaging
Not Provided
Principal Investigator: Sharon Mulvagh, MD Mayo Clinic
Lantheus Medical Imaging
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP