Coronary Artery Disease as a Cause of Morbidity and Mortality in Patients Suffering From Schizophrenia: Epidemiology and Status to Provide Prevention, Interventions and Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- CT coronary angiography - a quantitative clinical measurement
研究概览
简要总结
Schizophrenia is a severe mental illness associated with excess mortality and affecting nearly 1% of the population. The average life expectancy for patients diagnosed with schizophrenia has been 55-60 years through the last generations in Denmark, while the general population has over the same period of time experienced an increase in life expectancy. As a result, the standardized mortality rate for patients with schizophrenia has increased markedly over the last three decades and is currently a major public health concern. Causes of death are mainly cardiovascular disease and patients diagnosed with schizophrenia has a relative risk of cardiovascular disease that is about 2-fold higher than the general population.
详细描述
Little is known about severe progression of premature coronary arteriosclerosis in patients suffering from schizophrenia. Coronary artery calcium score is a well-defined measure to predict cardiovascular disease events, however there has not yet been any attempt to investigate whether there is an association between coronary artery calcium score and premature morbidity and mortality in patients diagnosed with schizophrenia.
The objective of this study is to investigate the progression of arteriosclerosis in patients with schizophrenia at different stages of the disease, and to offer and implement adequate treatment for these patients according to their somatic condition. This study will identify risk factors of somatic diseases in these patients, with specific focus on early diagnoses, prevention, intervention and treatment of arteriosclerosis in schizophrenic patients.
The investigation is about the possibility of detecting any differences between developing arteriosclerosis in schizophrenia patients versus the general population, and how common risk factors are contributing to this process. The results of this study should provide important modifications in the clinical guidelines for treatment of patients diagnosed with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a diagnosis of F20 schizophrenia.
- •Informed statement of consent
- •Age > 18
排除标准
- •Incompetency to create stabile relation or make agreements
- •Pregnancy and also breastfeeding women
- •Participants with severe claustrophobia
- •Participants with lack of ability to cooperate with the planned study program.
结局指标
主要结局
CT coronary angiography - a quantitative clinical measurement
时间窗: 6 years
CT coronary angiography is a non-invasive procedure that uses simple CT-scan without contrast to measure coronary calcifications
次要结局
- Echocardiography - Clinical objective evaluation(6 years)
- CT-scan of upper abdomen (CTUA) - Clinical objective evaluation(6 years)
- Cardiovascular magnetic resonance imaging(CMR) - Clinical objective evaluation(6 years)
- Urine sample - Objective clinical evaluation(6 years)
- Global Assessment of Functioning (GAF) - Clinical evaluation(6 years)
- Body Composition analysis (BCA) - Clinical objective evaluation(6 years)
- Charlson Co-morbidity index - Self-report questionnaire(6 years)
- Pulmonary function test (PFT) - Clinical objective evaluation(6 years)
- Toe brachial index (TBI) - Clinical objective evaluation(6 years)
- Blood test - Clinical objective evaluation(6 years)
- Lubben Social Network Scale-6 (LSNS-6) - Self-report questionnaire(6 years)
- Positive and Negative Syndrome Scale (PANNS) - Clinical psychiatric evaluation(6 years)
- Clinical Global Impression Scale (CGI) - Clinical psychiatric evaluation(6 years)
- Heart rate variability (HRV) - Clinical objective evaluation(6 years)
- Existing psychiatric and somatic diagnosis and treatment - Self-report questionnaire(6 years)
- Adipose tissue biopsy - Clinical objective evaluation(6 years)
研究者
Jørgen Aagaard
Chief consultant, Professor, Dr.Med.Sci.
Aalborg University Hospital