Coronary Artery Disease in Patients Suffering From Schizophrenia
- Conditions
- SchizophreniaCardiovascular Disease
- Interventions
- Other: Illness historyOther: Measure of social conditionsOther: Measure of psychiatric conditionProcedure: Cardiovascular measurement
- Registration Number
- NCT02885792
- Lead Sponsor
- Aalborg Psychiatric Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- Participants with a diagnosis of F20 schizophrenia.
- Informed statement of consent
- Age > 18
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Debuting and chronic schizophrenia Illness history ILLNESS HISTORY: * Existing psychiatric and somatic diagnosis and treatment * Charlson co-morbidity MEASURE OF SOCIAL CONDITIONS - For example Lubben Social Network Scale-6 and Brief Trauma Questionnaire. MEASURE OF PSYCHIATRIC CONDITION:: * Positive and Negative Syndrome Scale (PANSS) * Clinical Global Impression Scale (CGI) * Columbia Suicide Severity Rating Scale (C-SSRS) * Beck Cognitive Insight Scale * Birchwood Insight Scale CARDIOVASCULAR MEASUREMENT: CT Coronary angiography (CT-CAG) * Echocardiography * Heart rate variability (HRV) * Pulmonary function test (PFT) * Toe blood pressure (TBP) * Blood test * Body composition analysis * CT scan of upper abdomen * Cardiovascular magnetic resonance imaging (CMR) * Adipose tissue biopsy Debuting and chronic schizophrenia Measure of social conditions ILLNESS HISTORY: * Existing psychiatric and somatic diagnosis and treatment * Charlson co-morbidity MEASURE OF SOCIAL CONDITIONS - For example Lubben Social Network Scale-6 and Brief Trauma Questionnaire. MEASURE OF PSYCHIATRIC CONDITION:: * Positive and Negative Syndrome Scale (PANSS) * Clinical Global Impression Scale (CGI) * Columbia Suicide Severity Rating Scale (C-SSRS) * Beck Cognitive Insight Scale * Birchwood Insight Scale CARDIOVASCULAR MEASUREMENT: CT Coronary angiography (CT-CAG) * Echocardiography * Heart rate variability (HRV) * Pulmonary function test (PFT) * Toe blood pressure (TBP) * Blood test * Body composition analysis * CT scan of upper abdomen * Cardiovascular magnetic resonance imaging (CMR) * Adipose tissue biopsy Debuting and chronic schizophrenia Measure of psychiatric condition ILLNESS HISTORY: * Existing psychiatric and somatic diagnosis and treatment * Charlson co-morbidity MEASURE OF SOCIAL CONDITIONS - For example Lubben Social Network Scale-6 and Brief Trauma Questionnaire. MEASURE OF PSYCHIATRIC CONDITION:: * Positive and Negative Syndrome Scale (PANSS) * Clinical Global Impression Scale (CGI) * Columbia Suicide Severity Rating Scale (C-SSRS) * Beck Cognitive Insight Scale * Birchwood Insight Scale CARDIOVASCULAR MEASUREMENT: CT Coronary angiography (CT-CAG) * Echocardiography * Heart rate variability (HRV) * Pulmonary function test (PFT) * Toe blood pressure (TBP) * Blood test * Body composition analysis * CT scan of upper abdomen * Cardiovascular magnetic resonance imaging (CMR) * Adipose tissue biopsy Debuting and chronic schizophrenia Cardiovascular measurement ILLNESS HISTORY: * Existing psychiatric and somatic diagnosis and treatment * Charlson co-morbidity MEASURE OF SOCIAL CONDITIONS - For example Lubben Social Network Scale-6 and Brief Trauma Questionnaire. MEASURE OF PSYCHIATRIC CONDITION:: * Positive and Negative Syndrome Scale (PANSS) * Clinical Global Impression Scale (CGI) * Columbia Suicide Severity Rating Scale (C-SSRS) * Beck Cognitive Insight Scale * Birchwood Insight Scale CARDIOVASCULAR MEASUREMENT: CT Coronary angiography (CT-CAG) * Echocardiography * Heart rate variability (HRV) * Pulmonary function test (PFT) * Toe blood pressure (TBP) * Blood test * Body composition analysis * CT scan of upper abdomen * Cardiovascular magnetic resonance imaging (CMR) * Adipose tissue biopsy Matched controls Cardiovascular measurement CARDIOVASCULAR MEASUREMENT: * CT Coronary angiography (CT-CAG) * Echocardiography * Heart rate variability (HRV) * Pulmonary function test (PFT) * Toe blood pressure (TBP) * Blood test * Body composition analysis * CT scan of upper abdomen * Cardiovascular magnetic resonance imaging (CMR) * Adipose tissue biopsy
- Primary Outcome Measures
Name Time Method CT coronary angiography - a quantitative clinical measurement 6 years CT coronary angiography is a non-invasive procedure that uses simple CT-scan without contrast to measure coronary calcifications
- Secondary Outcome Measures
Name Time Method Echocardiography - Clinical objective evaluation 6 years Echocardiography is a non-invasive procedure that uses ultrasound waves to generate live images of the patient's heart
CT-scan of upper abdomen (CTUA) - Clinical objective evaluation 6 years CTUA uses X-rays to produce cross-sectional images of the heart and liver
Cardiovascular magnetic resonance imaging(CMR) - Clinical objective evaluation 6 years CMR uses a strong magnetic field including radio waves to generate images of the heart
Urine sample - Objective clinical evaluation 6 years Urine sample measures the content of melatonin, which is a hormone that controls the natural cycle of sleeping and waking hours.
Global Assessment of Functioning (GAF) - Clinical evaluation 6 years The GAF is a clinical evaluation of the patient's overall functioning level, including psychological, social and interpersonal, and occupational functioning of mental health-illness.
Body Composition analysis (BCA) - Clinical objective evaluation 6 years Using a standard weight to measure body composition for each patient
Charlson Co-morbidity index - Self-report questionnaire 6 years Measure of illness history with focus on which additional somatic or psychiatric diagnosis patients have.
Pulmonary function test (PFT) - Clinical objective evaluation 6 years PFT also known as spirometry is a procedure that measures lung function
Toe brachial index (TBI) - Clinical objective evaluation 6 years TBP is a procedure that measures the relationship between the systolic blood pressure at the toe and the arm
Blood test - Clinical objective evaluation 6 years Blood test is used to identify biomedical markers. A volume of 20 ml will be needed from each patient.
Lubben Social Network Scale-6 (LSNS-6) - Self-report questionnaire 6 years The LSNS-6 is a self-report questionnaire measuring social isolation, including relations to family and friends.
Positive and Negative Syndrome Scale (PANNS) - Clinical psychiatric evaluation 6 years The PANNS measures symptom severity in schizophrenia with focus on two distinct syndromes. The postive syndromes including productive symptoms, and the negative syndrome, including deficit features.
Clinical Global Impression Scale (CGI) - Clinical psychiatric evaluation 6 years The CGI is a measure of symptom severity, therapeutic response and general improvement.
Heart rate variability (HRV) - Clinical objective evaluation 6 years HRV is a non-invasive procedure that detects the function of the autonomic nervous system on the heart rhythm.
Existing psychiatric and somatic diagnosis and treatment - Self-report questionnaire 6 years Measure of illness history with focus on previous diagnosis and treatment
Adipose tissue biopsy - Clinical objective evaluation 6 years Adipose tissue biopsy is an invasive procedure that we use to understand the composition of fat acid for each patient in order to understand the correlation between fat acid and cardiovascular disease.
Trial Locations
- Locations (1)
Aalborg University Hospital, Psychiatric Hospital
🇩🇰Aalborg, Denmark