Clinical trial NCT00162370: A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease
Official title: SMART: Stress Echocardiography in Menopausal Women at Risk for Coronary Artery Disease Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Heart Disease
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 400
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up
timeFrame: 2 year and 5 year follow up
Secondary outcomes:
measure: Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 2 Year Follow-Up
timeFrame: 2-year follow-up
measure: Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up.
timeFrame: 2 year follow up
measure: Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up.
timeFrame: 2 year follow up
measure: Change in Brachial Artery Reactivity Was Assessed in in a Subset of Participants With and Without Major Adverse Cardiac Events at 2-year and 5-year Follow-up.
timeFrame: 2 year and 5 year follow up
measure: Mean Baseline Calcium Score of Participants With and Without Major Cardiac Events at 2-year Follow up.
timeFrame: 2 year follow up
measure: The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography
timeFrame: 60 days
measure: Participants With Positive and Negative Angiography Compared With Their ECG Results
timeFrame: 60 days
measure: Number of Participants With Abnormal ECG and With Future Major Adverse Cardiac Events (MACE) at 5 Years Follow-Up
timeFrame: 5 year follow up
measure: Change in Brain Natriuretic Peptide (BNP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up.
timeFrame: 5 year follow up
measure: Change in Atrial Natriuretic Peptide (ANP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up.
timeFrame: 5 year follow up
measure: Mean Calcium Score of Participants With and Without Major Cardiac Events at 5-year Follow up.
timeFrame: 5 year follow up
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Local Institution
state: Arizona
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Rochester
country: United States
facility: Local Institution
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sharon Mulvagh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdelmoneim SS, Ball CA, Mantovani F, Hagen ME, Eifert-Rain S, Wilansky S, Castello R, Pellikka PA, Best PJM, Mulvagh SL. Prognostic Utility of Stress Testing and Cardiac Biomarkers in Menopausal Women at Low to Intermediate Risk for Coronary ARTery Disease (SMART Study): 5-Year Outcome. J Womens Health (Larchmt). 2018 May;27(5):542-551. doi: 10.1089/jwh.2017.6506. Epub 2018 Apr 19.
citation: 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.