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

Lantheus Medical Imaging

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Heart Disease

Treatments: Drug: Perflutren Lipid Microsphere Injectable Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162370

DMP 115-407

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Peri or Post menopausal women either:

  • without symptoms but with risk factors for heart disease OR
  • experiencing atypical chest pain, OR
  • experiencing exertional dyspnea AND 2 or more risk factors for CAD

• Must be able to perform an exercise stress test

Peri-or post-menopausal (including surgical menopause) based on history.

• Post-menopausal is defined as females age 40-65 who self-report the absence of menstrual periods for at least 12 months.
• Peri-menopausal is defined as females age 40-65 who self-report the absence or irregularity of menstrual periods for 6-12 months.
• Surgical menopause is defined as females who have had a bilateral salpingo-oophorectomy with or without hysterectomy.

Exclusion criteria

• Previous confirmed heart disease

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Definity

Experimental group

Description:

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.

Treatment:

Drug: Perflutren Lipid Microsphere Injectable Suspension