Clinical trial NCT02885792: Coronary Artery Disease in Patients Suffering From Schizophrenia
Official title: Coronary Artery Disease as a Cause of Morbidity and Mortality in Patients Suffering From Schizophrenia: Epidemiology and Status to Provide Prevention, Interventions and Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Cardiovascular Disease
Keywords: Schizophrenia
Cardiovascular disease
Premature mortality
Arteriosclerosis
Risk factor
Intervention
Treatment
Somatic morbidity
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CT coronary angiography - a quantitative clinical measurement
timeFrame: 6 years
Secondary outcomes:
measure: Existing psychiatric and somatic diagnosis and treatment - Self-report questionnaire
timeFrame: 6 years
measure: Charlson Co-morbidity index - Self-report questionnaire
timeFrame: 6 years
measure: Lubben Social Network Scale-6 (LSNS-6) - Self-report questionnaire
timeFrame: 6 years
measure: Global Assessment of Functioning (GAF) - Clinical evaluation
timeFrame: 6 years
measure: Positive and Negative Syndrome Scale (PANNS) - Clinical psychiatric evaluation
timeFrame: 6 years
measure: Clinical Global Impression Scale (CGI) - Clinical psychiatric evaluation
timeFrame: 6 years
measure: Echocardiography - Clinical objective evaluation
timeFrame: 6 years
measure: Heart rate variability (HRV) - Clinical objective evaluation
timeFrame: 6 years
measure: Pulmonary function test (PFT) - Clinical objective evaluation
timeFrame: 6 years
measure: Toe brachial index (TBI) - Clinical objective evaluation
timeFrame: 6 years
measure: Blood test - Clinical objective evaluation
timeFrame: 6 years
measure: Body Composition analysis (BCA) - Clinical objective evaluation
timeFrame: 6 years
measure: CT-scan of upper abdomen (CTUA) - Clinical objective evaluation
timeFrame: 6 years
measure: Cardiovascular magnetic resonance imaging(CMR) - Clinical objective evaluation
timeFrame: 6 years
measure: Adipose tissue biopsy - Clinical objective evaluation
timeFrame: 6 years
measure: Urine sample - Objective clinical evaluation
timeFrame: 6 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital, Psychiatric Hospital
Study officials:
affiliation: Aalborg University Hospital, Psychiatric Hospital
name: Svend E. Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trab T, Attar R, Jensen SE, Grontved S, Frokjaer JB, Polcwiartek C, Nielsen RE. Coronary artery calcium in patients with schizophrenia. BMC Psychiatry. 2021 Aug 23;21(1):422. doi: 10.1186/s12888-021-03412-x.