Phase 4
N=366
A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease
Coronary Artery Disease · Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00162370 ↗Enrolled (actual)
366
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: 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 Participants — p=0.014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Perflutren Lipid Microsphere Injectable Suspension (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Lantheus Medical Imaging
- Primary completion
- Sep 2012
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 | — |
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.
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). 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.