Coronary Artery Disease in Patients Suffering From Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02885792
• Other study ID #: N-20140047
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2016
• Last updated: January 30, 2017
• Start date: September 2015
• Est. completion date: September 2020

Study information

• Verified date: January 2017
• Source: Aalborg Universitetshospital
• Contact: Jørgen Aagaard, MD
• Phone: 97643626
• Email: joaa[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Schizophrenia

Intervention

Other:
• Illness history
Existing psychiatric and somatic diagnosis and treatment. Charlson co-morbidity Index.
• Measure of social conditions
A self-report questionnaire measuring social isolation, including relations to family and friends.
• Measure of psychiatric condition
This method measures symptom severity, therapeutic response and general improvement, suicidal ideation, cognitive insight and awareness of illness and need for treatment and the ability to relabel symptoms.

Procedure:
• Cardiovascular measurement
This procedure is used to detect early identification of cardiovascular disease progression.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital, Psychiatric Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Psychiatric Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT coronary angiography - a quantitative clinical measurement	CT coronary angiography is a non-invasive procedure that uses simple CT-scan without contrast to measure coronary calcifications	6 years
Secondary	Existing psychiatric and somatic diagnosis and treatment - Self-report questionnaire	Measure of illness history with focus on previous diagnosis and treatment	6 years
Secondary	Charlson Co-morbidity index - Self-report questionnaire	Measure of illness history with focus on which additional somatic or psychiatric diagnosis patients have.	6 years
Secondary	Lubben Social Network Scale-6 (LSNS-6) - Self-report questionnaire	The LSNS-6 is a self-report questionnaire measuring social isolation, including relations to family and friends.	6 years
Secondary	Global Assessment of Functioning (GAF) - Clinical evaluation	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.	6 years
Secondary	Positive and Negative Syndrome Scale (PANNS) - Clinical psychiatric evaluation	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.	6 years
Secondary	Clinical Global Impression Scale (CGI) - Clinical psychiatric evaluation	The CGI is a measure of symptom severity, therapeutic response and general improvement.	6 years
Secondary	Echocardiography - Clinical objective evaluation	Echocardiography is a non-invasive procedure that uses ultrasound waves to generate live images of the patient's heart	6 years
Secondary	Heart rate variability (HRV) - Clinical objective evaluation	HRV is a non-invasive procedure that detects the function of the autonomic nervous system on the heart rhythm.	6 years
Secondary	Pulmonary function test (PFT) - Clinical objective evaluation	PFT also known as spirometry is a procedure that measures lung function	6 years
Secondary	Toe brachial index (TBI) - Clinical objective evaluation	TBP is a procedure that measures the relationship between the systolic blood pressure at the toe and the arm	6 years
Secondary	Blood test - Clinical objective evaluation	Blood test is used to identify biomedical markers. A volume of 20 ml will be needed from each patient.	6 years
Secondary	Body Composition analysis (BCA) - Clinical objective evaluation	Using a standard weight to measure body composition for each patient	6 years
Secondary	CT-scan of upper abdomen (CTUA) - Clinical objective evaluation	CTUA uses X-rays to produce cross-sectional images of the heart and liver	6 years
Secondary	Cardiovascular magnetic resonance imaging(CMR) - Clinical objective evaluation	CMR uses a strong magnetic field including radio waves to generate images of the heart	6 years
Secondary	Adipose tissue biopsy - Clinical objective evaluation	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.	6 years
Secondary	Urine sample - Objective clinical evaluation	Urine sample measures the content of melatonin, which is a hormone that controls the natural cycle of sleeping and waking hours.	6 years