Impact of Stress on Cardiovascular Events in Patients with Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), Coronary Heart Disease (CHD) Death, or chronic limb ischemia and amputation
研究概览
简要总结
Atherosclerotic cardiovascular disease is the leading cause of morbidity and mortality worldwide. Patients with peripheral arterial disease are at increased risk suffering from major adverse cardiac and limb events. Acute and chronic stress affect the cardiovascular system. Long-term negative stressors lead to cardiovascular diseases and can aggravate already existing cardiovascular diseases. However, current guidelines on cardiovascular disease prevention highlight stress as a cardiovascular risk factor there is a lack of consensus about the definition and measurement of stress. The aim of the proposed trial is to evaluate different stress measuring methods in patients with PAD depending on the occurrence of cardiovascular events.
详细描述
Based on World Health Organization data, atherosclerotic cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. Peripheral arterial disease (PAD) is a poly-vascular disease in multiple arterial beds mostly associated with high atherosclerotic burden. It is estimated that around 50 million people in Europe alone suffer from PAD and the prevalence increases with age. The cause of CVD, such as PAD, coronary artery disease (CAD) or cerebrovascular disease, is atherosclerosis, a systemic chronic inflammatory vascular disease. Patients with CVD are at increased risk of life-threatening complications such as acute limb events, stroke and myocardial infarction combined with an impaired quality of life.
Acute and chronic stress affect the cardiovascular system. Numerous studies have shown the relationship between chronic stress and cardiovascular diseases. On the one hand, permanent negative stressors lead to cardiovascular diseases via different pathways such as the hypothalamic-pituitary-adrenal (HPA) axis or the autonomic nervous system, and, on the other hand, stress can aggravate an already existing CVD. In addition, cardiovascular risk factors like hypertension and hypercholesteremia are negatively influenced by stress. Stress as a cardiovascular risk factor is receiving increasing attention, leading to its recognition in current guidelines on cardiovascular disease prevention.
Due to the demographic development of an ageing population and the simultaneous increase in atherogenic risk factors, a further rise of patients with CVD will be expected in the future. Thus, sufficient assessment of cardiovascular risk in patients with PAD and adequate stress evaluation are elementary. However, there is a lack of consensus about the definition and measurement of stress.
Therefore, the investigators aim to evaluate and compare the efficiency of different stress measuring methods depending on the occurrence of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with PAD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of lower extremity PAD based on:
- •Limb bypass surgery or
- •aorta-femoral bypass surgery or
- •percutaneous transluminal angioplasty revascularization of the iliac or infrainguinal arteries or
- •limb or foot amputation for arterial vascular disease or
- •intermittent claudication and one or more of either an ankle brachial index (ABI) of less than 0.90 or a peripheral artery stenosis (≥50%) documented by angiography or duplex ultrasound or carotid revascularization or asymptomatic carotid artery stenosis of at least 50% diagnosed by duplex ultrasound or angiography
排除标准
- •atrial fibrillation
- •high premature ventricular contractions burden
- •pacemaker with constant ventricular pacing
- •antiarrhythmic drugs class I or III
结局指标
主要结局
Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), Coronary Heart Disease (CHD) Death, or chronic limb ischemia and amputation
时间窗: Baseline, after 6 months, after 12 months
Based on the COMPASS trial MACE and MALE includes the composite of cardiovascular death, myocardial infarction, acute limb ischaemia, chronic limb ischaemia and amputation. MACE and MALE will be evaluated at baseline and after 6 and 12 months
Pychological stress
时间窗: Baseline, after 6 months, after 12 months
Pychological stress is evaluated by a composite psychometric measure of stress level by using a mean rank at baseline and after 1 year. It is based on a published RCT by Blumenthal et al. and includes the Beck Depression Inventory II (BDI-II), State-Trait Anxiety inventory (STAI), Patient-Reported Outcomes Measurement Information System (PROMIS) Anger, General Health Questionnaire (GHQ) and Perceived Stress Scale (PSS). A range from 1 to 147 was present with higher scores suggestive of better function
Heart rate variability (HRV)
时间窗: Baseline, after 6 months, after 12 months
Heart rate variability (HRV) is an indirect marker of autonomic nervous system activity and describes the oscillations between the R-R intervals in the electrocardiogram. It allows a relatively superficial insight into the heart-brain interaction and reflects the psycho-emotional status such as stress or anxiety. According to the guidelines we chose a short-time HRV with 5 minutes of recording
Proinflammatory mediators - IL-6
时间窗: Baseline, after 6 months, after 12 months
IL-6 is measured in pg/ml. Standard value is under 2.7 pg/ml. Higher values indicate an increased stress level
Proinflammatory mediators - IL-1ß
时间窗: Baseline, after 6 months, after 12 months
IL-1ß is measured in pg/ml. Standard value is under 5 pg/ml. Higher values indicate an increased stress level
Proinflammatory mediators - TNFalpha
时间窗: Baseline, after 6 months, after 12 months
TNFalpha is measured in pg/ml. Standard value is under 2.8 pg/ml. Higher values indicate an increased stress level
Proinflammatory mediators - hsCRP
时间窗: Baseline, after 6 months, after 12 months
High sensitive-c-reactive protein (hsCRP) is measured in mg/dl. Standard value is under 0.02 mg/dl. Higher values indicate an increased stress level
Hair cortisol concentration
时间窗: Baseline, after 6 months, after 12 months
Hair cortisol is reliable biomarker of chronic stress that offers a retrospective non-invasive measurement of long-term HPA-axis activity over several weeks or months. The cortisol concentration, measured in pg/ml, of a 3 cm hair segment using liquid chromatography tandem mass spectrometry will be analyzed. Higher values indicate an increased stress level
次要结局
- Ankle-brachial index (ABI)(Baseline, after 6 months, after 12 months)
- PROMIS-Anger Scale(Baseline, after 6 months, after 12 months)
- LDL-Cholesterol(Baseline, after 6 months, after 12 months)
- Anxiety symptoms (STAI)(Baseline, after 6 months, after 12 months)
- Changes in functional capacity(Baseline, after 6 months, after 12 months)
- Serum-cortisol(Baseline, after 6 months, after 12 months)
- Depression symptoms (BDI-II)(Baseline, after 6 months, after 12 months)
- GHQ(Baseline, after 6 months, after 12 months)
- Health-related quality of life(Baseline, after 6 months, after 12 months)
- Perceived Stress Scale(Baseline, after 6 months, after 12 months)