Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 6
- 主要终点
- Cardiovascular Events
研究概览
简要总结
The purpose of this study is to look at the link between emotional stress and heart disease in men and women. Taking part in this study involves one clinic visit, one week of at home monitoring, and follow up phone calls every 6 months for 3 years.
详细描述
In the U.S. and globally, coronary heart disease (CHD) is the number one killer of women. Despite scientific advances, it is unclear whether the pathophysiology of CHD differs between women and men. The study of CHD in women has historically been centered on older women; however, women with early-onset CHD are informative for the study of early risk factors and pathophysiology. Furthermore, young women with a myocardial infarction (MI) have emerged as a group in need of special study, as this group has higher mortality compared with men of similar age despite less severe disease. These disparities remain unexplained and suggest sex differences in the pathophysiology, risk factors, and prognostic factors of acute MI.
The psychosocial sphere is a largely neglected area for CHD prevention in women. Social and emotional exposures, mostly beginning early in life (depression, early life adversities, poverty, and posttraumatic stress symptoms), are more common in younger women with MI compared with men and community controls. In addition to being more prevalent, emotional stress may be a stronger risk factor in young women than in other groups. A significant challenge, however, is to measure stress validly.
Building on previous work, the current project will clarify sex differences in pathways of risk linking emotional stress to mental stress-induced myocardial ischemia (MSI) and cardiovascular outcomes in young post-MI patients. Within 8 months of MI, 310 patients ≤60 years of age (at the time of the MI), 50% women, will be tested in the lab with a stress challenge to assess MSI using an established protocol with myocardial perfusion imaging. Participants will be monitored at home for 1 week and then followed for clinical events for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of documented MI within the past 8 months
- •Age ≤60 at the time of MI
排除标准
- •History of unstable angina, MI, or decompensated heart failure in the past month
- •Patients deemed to be unsafe to hold anti-ischemic medications before testing (it is standard protocol to hold these meds before imaging studies)
- •Systolic blood pressure (SBP) >180 mm Hg or diastolic blood pressure (DBP) >110 mm Hg on the day of the test
- •Alcohol or substance abuse (past year), or severe psychiatric disorder other than major depression
- •Other serious medical disorders that may interfere with the study results
- •Postmenopausal hormone therapy (past 3 months)
- •Current psychotropic medications (past month) except anti-depressants
- •Pregnancy or breastfeeding (all women will receive a pregnancy test)
- •Severe aortic stenosis
- •Weight ≥ 360 pounds and/or body mass index (BMI) of 40 or greater (weight limit of the SPECT imaging table)
研究组 & 干预措施
Young Participants with Prior MI
Participants aged 60 or less who experienced a MI within the last 8 months underwent a stress challenge to assess MSI and were followed for 3 years.
干预措施: Stress Challenge (Other)
结局指标
主要结局
Cardiovascular Events
时间窗: 3 Years
The main outcome was a composite endpoint of recurrent MI, unstable angina, hospitalization for decompensated heart failure, and cardiovascular (CV) death. A mental stress-induced myocardial ischemia (MSI) status of positive or negative was used as the main predictor in regression models.
次要结局
- Myocardial Infarction or Cardiovascular Death(3 Years)
- Cardiovascular Events Excluding Heart Failure(3 Years)
- Cardiovascular Death(3 Years)
- Total Mortality(3 Years)