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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
  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: 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:


Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Percentage of Low to Intermediate Risk Patients Experiencing Future Major Adverse Cardiac Events (MACE) [ Time Frame: 2 or 5 year follow up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ 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
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Perflutren Lipid Microsphere Injectable Suspension
Activated DEFINITY 10ug/kg by bolus injection
Other Name: DEFINITY

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.
  Eligibility

Ages Eligible for Study:   48 Years to 60 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: April 17, 2016
Last Updated: October 14, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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 December 09, 2016