Phase 4
Completed N=366
A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease
Source: ClinicalTrials.gov NCT00162370 ↗Enrolled (actual)
366
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up — 2; 1; 1; 5 Participants — p=0.014
◆ Published Evidence
Emerging
11citations · ~1 / year
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.
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.
Linked Publications (2)
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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.
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Effect of stress echocardiography testing on changes in cardiovascular risk behaviors in postmenopausal women: a prospective survey study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up |
2; 1; 1; 5 | 0.014 sig |
| SECONDARY Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 2 Year Follow-Up |
3; 15 | <0.0001 sig |
| SECONDARY Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. |
5.2; 10.7 | — |
| SECONDARY Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. |
5.9; 101 | — |
| SECONDARY 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. |
7.8; 7.3 | — |
| SECONDARY Mean Baseline Calcium Score of Participants With and Without Major Cardiac Events at 2-year Follow up. |
45 | — |
| SECONDARY The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography |
7; 12; 1; 4 | — |
| SECONDARY Participants With Positive and Negative Angiography Compared With Their ECG Results |
15; 4; 3; 2 | — |
| SECONDARY Number of Participants With Abnormal ECG and With Future Major Adverse Cardiac Events (MACE) at 5 Years Follow-Up |
16.7; 5.0 | — |
| SECONDARY Change in Brain Natriuretic Peptide (BNP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. |
4.9; 4.1 | — |
| SECONDARY Change in Atrial Natriuretic Peptide (ANP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. |
-37.4; 70.5 | — |
| SECONDARY Mean Calcium Score of Participants With and Without Major Cardiac Events at 5-year Follow up. |
40.2; 100 | — |
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
Data sourced from ClinicalTrials.gov (NCT00162370) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.