A Comparison of Hair Cortisol and Testosterone Levels in Patients With Acute MI and Controls With and Without Chronic Cardiovascular Disease or Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Comparison of hair cortisol and testosterone levels between the patients with acute MI and the 2 control groups
研究概览
简要总结
The purpose of this study is to determine whether hair levels of cortisol and testosterone are elevated in patients with acute MI compared to controls.
详细描述
Recently there has been a growing interest in measuring hair cortisol and testosterone levels. Hair grows approximately 1 centimeter per month, and hair analysis accurately reflects long-term endogenous production of these hormones. The association of elevated hair cortisol levels with chronic stress has been reported in several studies. Furthermore, we have recently demonstrated higher hair cortisol levels in patients admitted with acute myocardial infarction compared with patients admitted for other indications (the manuscript has recently been submitted for publication). Nevertheless it is still not clear whether hair cortisol levels are a risk factor for acute coronary event or for chronic cardiovascular diseases. In order to address this issue, further comparison of hair cortisol levels between patients with acute MI and a control group of patients with chronic cardiovascular diseases is needed.
Several studied have reported that endogenous testosterone concentrations are inversely associated with cardiovascular mortality and progression of atherosclerosis both in the coronary and the peripheral arteries. However these studies used a single serum testosterone level and therefore may not accurately represent the chronic endogenous production of this hormone. It may be that the association of testosterone levels and cardiovascular disease may be better evaluated using the hair technique. Nevertheless this association has not been studied yet.
Aim of the study:
To compare hair cortisol and testosterone levels in patients admitted with acute MI to stable patients with prior cardiovascular diseases or diabetes and patients with no history of cardiovascular diseases.
Secondary endpoint:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with acute MI ( elevated cardiac enzymes + chest pain or typical ECG changes)
- •Control group 1:
- •Will include patients with at least 1 of the following:
- •Prior cardiovascular disease (CVD). CVD is defined as a history of hospital admission due to acute coronary artery occlusion, percutaneous coronary interventions (PCI), coronary artery bypass grafting, any aortic or peripheral vascular disease that was either symptomatic or required intervention, ischemic or hemorrhagic stroke or transient ischemic attack.
- •Diabetes mellitus. (Defined when it is reported by the patient or appears in his medical records, or if the patient has received regular treatment with oral hypoglycemic agents or insulin)
- •Control group 2:
- •Patients without prior cardiovascular disease or diabetes mellitus (see definitions above).
排除标准
- •Corticosteroid treatment in the last 12 months.
- •Diagnosis of Cushing's or Addison's disease.
- •Diagnosed hypogonadism treated with testosterone
- •Dyed hair.
- •Inability to sign inform consent.
- •Any hospital admission during the 6 months prior to enrolment
- •Morbid obesity (BMI>35)
结局指标
主要结局
Comparison of hair cortisol and testosterone levels between the patients with acute MI and the 2 control groups
时间窗: 1 day
The study does not include a follow-up period
次要结局
- Correlation of hair cortisol and testosterone with the burden of coronary atherosclerosis in the MI group(1 day)