Coronary Artery Disease in Patients Suffering From Schizophrenia

Aalborg Psychiatric Hospital

Status: Unknown

Conditions: Schizophrenia; Cardiovascular Disease

Treatments: Other: Measure of psychiatric condition; Other: Measure of social conditions; Procedure: Cardiovascular measurement; Other: Illness history

Study type: Interventional

Funder types: Other

Identifiers

NCT02885792

N-20140047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with a diagnosis of F20 schizophrenia.
• Informed statement of consent
• Age > 18

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Debuting and chronic schizophrenia

Experimental group

Description:

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

Treatment:

Other: Measure of psychiatric condition

Procedure: Cardiovascular measurement

Other: Illness history

Other: Measure of social conditions

Matched controls

Active Comparator group

Description:

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

Treatment:

Procedure: Cardiovascular measurement