Coronary Artery Disease in Patients Suffering From Schizophrenia

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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease; Schizophrenia
• Intervention / Treatment: Other: Illness history; Other: Measure of social conditions; Other: Measure of psychiatric condition; Procedure: Cardiovascular measurement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jørgen Aagaard, MD; Phone Number: 45 97643626; Email: joaa@rn.dk
• Study Contact Backup: Name: Svend E. Jensen, MD; Email: svend.eggert.jensen@rn.dk

Study Locations

• Denmark
  • Aalborg, Denmark, DK-9000
    • Recruiting
    • Aalborg University Hospital, Psychiatric Hospital
    • Contact: Jørgen Aagaard, MD; Phone Number: 45 97643626; Email: joaa@rn.dk
    • Principal Investigator: Svend E. Jensen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Debuting and chronic schizophrenia; 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	Other: Illness history; Existing psychiatric and somatic diagnosis and treatment. Charlson co-morbidity Index.; Other: Measure of social conditions; A self-report questionnaire measuring social isolation, including relations to family and friends.; Other: 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.
Active Comparator: Matched controls; 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	Procedure: Cardiovascular measurement; This procedure is used to detect early identification of cardiovascular disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Existing psychiatric and somatic diagnosis and treatment - Self-report questionnaire	Measure of illness history with focus on previous diagnosis and treatment	6 years
Charlson Co-morbidity index - Self-report questionnaire	Measure of illness history with focus on which additional somatic or psychiatric diagnosis patients have.	6 years
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
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
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
Clinical Global Impression Scale (CGI) - Clinical psychiatric evaluation	The CGI is a measure of symptom severity, therapeutic response and general improvement.	6 years
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
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
Pulmonary function test (PFT) - Clinical objective evaluation	PFT also known as spirometry is a procedure that measures lung function	6 years
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
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
Body Composition analysis (BCA) - Clinical objective evaluation	Using a standard weight to measure body composition for each patient	6 years
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
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
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
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

Collaborators and Investigators

• Sponsor: Aalborg Psychiatric Hospital
• Investigators: Principal Investigator: Svend E. Jensen, MD, Aalborg University Hospital, Psychiatric Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Treatment; Cardiovascular disease; Schizophrenia; Intervention; Arteriosclerosis; Risk factor; Premature mortality; Somatic morbidity
• Additional Relevant MeSH Terms: Mental Disorders; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Schizophrenia
• Other Study ID Numbers: N-20140047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO