SMART: Stress Echocardiography in Menopausal Women at Risk for Coronary Artery Disease Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Previous confirmed heart disease
研究组 & 干预措施
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.
干预措施: Perflutren Lipid Microsphere Injectable Suspension (Drug)
结局指标
主要结局
Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up
时间窗: 2 year and 5 year follow up
Peri- or post-menopausal female participants with an intermediate pre-test likelihood of coronary artery disease (CAD) received a Definity contrast-enhanced stress echocardiography study at baseline using either treadmill exercise or dobutamine stresss. Images were evaluated for wall motion abnormalities. The results were compared to patient history on 2-year and 5-year follow up to identify the potential of stress echocardiography for predicting those at higher risk of experiencing future cardiac events. Major adverse cardiac events (MACE) are defined as * Cardiac death * Myocardial infarction * Cardiac revascularization (PCI or CABG) * Hospitalization for chest pain or to rule out myocardial infarction * Development of typical angina * Development of heart failure
次要结局
- Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 2 Year Follow-Up(2-year follow-up)
- Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up.(2 year follow up)
- Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up.(2 year follow up)
- 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.(2 year and 5 year follow up)
- Mean Baseline Calcium Score of Participants With and Without Major Cardiac Events at 2-year Follow up.(2 year follow up)
- The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography(60 days)
- Participants With Positive and Negative Angiography Compared With Their ECG Results(60 days)
- Number of Participants With Abnormal ECG and With Future Major Adverse Cardiac Events (MACE) at 5 Years Follow-Up(5 year follow up)
- Change in Brain Natriuretic Peptide (BNP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up.(5 year follow up)
- Change in Atrial Natriuretic Peptide (ANP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up.(5 year follow up)
- Mean Calcium Score of Participants With and Without Major Cardiac Events at 5-year Follow up.(5 year follow up)