Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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: October 14, 2016
Last verified: September 2014

September 9, 2005
October 14, 2016
April 2004
September 2012   (Final data collection date for primary outcome measure)
Percentage of Low to Intermediate Risk Patients Experiencing Future Major Adverse Cardiac Events (MACE) [ Time Frame: 2 or 5 year follow up ]
Determine the prognostic value of stress echocardiography as a screening examination in peri- or post-meopausal female patients with an intermediate pre-test likelihood of coronary artery disease (CAD) to identify patients at higer risk of experiencing future cardiac events.
  • 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
  • Percent of Subjects With Abnormal Stress ECG Testing for Identifying Patients With Major Adverse Cardiac Events (MACE) [ Time Frame: 2 or 5 year follow up ]
    Stress ECG test interpretation will be summarized using number and percentage of patients with normal and abnormal ECG with and without MACE
  • Determine the Value of Exercise Induced Changes in Levels of Cardiac Peptides; Brain Natriuretic Peptide (BNP) in Identifying Patients With Cardiac Events During Follow-up. [ Time Frame: 2 year or 5 year follow up ]
  • Determine the Value of Brachial Artery Reactivity for Identifying Patients With Cardiac Events During Follow-up. [ Time Frame: End of Study ]
  • 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 ]
  • 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 ]
  • 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.
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.
Interventional
Phase 4
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
Experimental: Definity
All patients will undergo a gray scale baseline unenhanced imaging session (apical 2- or 4 chamber view), as well as a DEFINITY (Perflutren Lipid Microsphere Injectable Suspension)-enhanced rest and a DEFINITY enhanced exercise or dobutamine stress echocardiography imaging session. The unenhanced and DEFINITY-enhanced rest and stress echocardiography imaging sessions will be performed on the same day. For the DEFINITY-enhanced imaging sessions all patients will receive diluted DEFINITY intravenously (IV). Diluted DEFINITY will be prepared by mixing 1 mL of activated DEFINITY® with 9 mL of normal saline in a 10 mL syringe.
Intervention: Drug: Perflutren Lipid Microsphere Injectable Suspension
Mantovani F, Abdelmoneim SS, Zysek V, Eifert-Rain S, Mulvagh SL. Effect of stress echocardiography testing on changes in cardiovascular risk behaviors in postmenopausal women: a prospective survey study. J Womens Health (Larchmt). 2014 Jul;23(7):581-7. doi: 10.1089/jwh.2013.4604. Epub 2014 Jun 16.

*   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
Sexes Eligible for Study: Female
48 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00162370
DMP 115-407
No
Not Provided
No
Not Provided
Lantheus Medical Imaging
Lantheus Medical Imaging
Not Provided
Principal Investigator: Sharon Mulvagh, MD Mayo Clinic
Lantheus Medical Imaging
September 2014

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