Coronary artery disease as a cause of morbidity and mortality in patients suffering from schizophrenia: protocol for a prospective cohort study with long-term follow-up

Background: Schizophrenia is associated with excess mortality primarily due to cardiovascular disease. Unhealthy lifestyle and sideeffects from pharmacologic treatment are among the risk factors that highly contribute to somatic disease in patients with schizophrenia. While the number of cardiac deaths is declining in the general population, the cardiac mortality in patients with schizophrenia remains high. No other studies have so far investigated the presence and progression of arteriosclerosis in patients diagnosed with schizophrenia. The primary aim of this clinical study is to reduce the high rate of cardiac mortality in patients with schizophrenia. Methods/Design: The present clinical trial involves 300 patients with schizophrenia, including 100 patients with debut schizophrenia and 200 patients with chronic schizophrenia with a clinical follow-up every third year from first examination. Patients are recruited from the North Denmark Region with a minimum age of 18 years and with the requirement of having an ICD-10 diagnosis of F20 or F25. The primary outcome is the presence and progression of atherosclerosis measured by CT coronary angiography at baseline and follow-up periods. The secondary outcomes are cardiovascular measurements, illness history, social conditions as well as psychiatric conditions measured at baseline and some measured again during follow-up. Discussion: Routine screening of cardiovascular risk factors in patients with schizophrenia are necessary to detect early signs of cardiovascular disease in order to reduce the excess cardiac mortality. The end result of this study may contribute to prolonging lifeexpectancy for patients with schizophrenia and providing modifications in the clinical guidelines for treatment of coronary artery disease in patients with schizophrenia. Trial registration: ClinicalTrials.gov identifier NCT02885792; registered on July 1, 2016.