A Psycho-biochemical Perspective on Non-significant Coronary Artery Disease: a Prospective Cohort Study of Classic and Novel Risk Markers.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 547
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Events (MACE)
研究概览
简要总结
Psychosocial factors have been found to be associated with an increased risk for coronary artery disease incidence, progression and worse clinical outcomes.
Patients with non-significant coronary artery disease (confirmed vascular irregularities, but <60% coronary occlusion) often present with complaints such as chest pain, which warrant screening by coronary angiography (CAG) or computed tomography (CT scan). The prognosis of this group of patients with mild stenosis remains to be investigated in more detail, and we propose that psychosocial factors play a role in the clinical prognosis and patient reported outcomes in this group.
A special focus lies within examining personality characteristics, of which Type D personality is a primary predictor variable for prognosis. Type D personality is characterised by high negative affect and high social inhibition. In addition to psychosocial factors (personality, mood state, social support, SES), biomarkers(inflammation, clotting, DNA) as well as standard clinical risk factors (metabolic syndrome, activity level, smoking, medication use, disease severity) will be investigated.
The goal of the proposed study is to investigate a preexisting psycho-biochemical risk profile for major adverse cardiovascular events (MACE) and patient perceived symptoms in a group with angiographically or CT-scan confirmed, non-significant coronary artery disease.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Based on quantitative coronary angiography (CAG): visible, but non-significant (<60% coronary occlusion) vascular irregularities and mild coronary stenosis.
- •Based on 64-slice CT-scan (CT-scan): detected non-significant stenosis (calcium score >= lowest 10th percentile), and not eligible for CAG.
排除标准
- •Normal coronary arteries (based on CAG or CT scan)
- •Significant occlusion of coronary arteries (>=60% stenosis)
- •Eligible for coronary intervention such as PCI or CABG
- •History of coronary events (being either MI,PCI, CABG, heart failure)
- •For the CT-screened group: eligible for CAG based on the CT-scan
- •Serious comorbid conditions such as chronic kidney failure, or receiving chemotherapy
- •Insufficient knowledge of the Dutch language
结局指标
主要结局
Major Adverse Cardiac Events (MACE)
时间窗: Average 42 months (Range 12-72; at least 12 months after inclusion final participant)
MACE includes the occurence of a recurrent coronary angiography, emergency hospitalization (for cardiac reasons), myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG), mortality (cardiac/noncardiac)
Patient Perceived Health Status
时间窗: 12 and 24 months
patient perceived health status includes self-reported chest pain, disease specific health status, generic health status, fatigue and mood (depression/anxiety). Double time point was included for this outcome measure to examine changes over time, compared to baseline.
次要结局
- Psychosocial factors(baseline, 12 and 24 months)
- Biochemical correlates(baseline, 12 and 24 months)
研究者
Paula M.C. Mommersteeg
Assistant Professor
Tilburg University