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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 3 Imaging and Safety Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing SPECT Imaging

NCT00156793

Coronary Artery Disease

COMPLETED PHASE3

Prospective Analysis and Comparison of Stress Echo to Real-Time Myocardial Contrast Stress Echo

NCT00575549

Evaluation of Troponin I Levels

NO_LONGER_AVAILABLE

Stress Echocardiography to Identify Chemotherapy Induced Cardiotoxicity in Cancer Patients With Heart Failure Risk

NCT05950399

Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

COMPLETED NA

Dobutamine Stress Echocardiography in Cardiac Resynchronization Therapy (CRT) Patients Selection

NCT00828360

Heart Failure

UNKNOWN

Myocardial Contrast Echocardiography for the Assessment of the Infarct Related Artery & Risk Area in Patients w/ NSTEMI.

NCT02014701

STEMI

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Perflutren Lipid Microsphere Injectable Suspension

Intervention Type DRUG

Activated DEFINITY 10ug/kg by bolus injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Perflutren Lipid Microsphere Injectable Suspension

Activated DEFINITY 10ug/kg by bolus injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DEFINITY

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.