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Clinical Trials/NCT02885792
NCT02885792
Unknown
Not Applicable

Coronary Artery Disease as a Cause of Morbidity and Mortality in Patients Suffering From Schizophrenia: Epidemiology and Status to Provide Prevention, Interventions and Treatment

Aalborg Psychiatric Hospital1 site in 1 country300 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Aalborg Psychiatric Hospital
Enrollment
300
Locations
1
Primary Endpoint
CT coronary angiography - a quantitative clinical measurement
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
September 2020
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aalborg Psychiatric Hospital
Responsible Party
Principal Investigator
Principal Investigator

Jørgen Aagaard

Chief consultant, Professor, Dr.Med.Sci.

Aalborg University Hospital

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.

Outcomes

Primary Outcomes

CT coronary angiography - a quantitative clinical measurement

Time Frame: 6 years

CT coronary angiography is a non-invasive procedure that uses simple CT-scan without contrast to measure coronary calcifications

Secondary Outcomes

  • 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)

Study Sites (1)

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