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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00162370
First received: September 9, 2005
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: SMART: Stress Echocardiography in Menopausal Women at Risk for Coronary Artery Disease Trial

Resource links provided by NLM:

Drug Information available for: Perflutren
U.S. FDA Resources

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 [ 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 400
Study Start Date: April 2004
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Perflutren Lipid Microsphere Injectable Suspension
    Activated DEFINITY 10ug/kg by bolus injection
    Other Name: DEFINITY
  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

No publications provided

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162370     History of Changes
Other Study ID Numbers: DMP 115-407
Study First Received: September 9, 2005
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013