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Coronary Artery Disease in Patients Suffering From Schizophrenia

Primary Purpose

Schizophrenia, Cardiovascular Disease

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Illness history
Measure of social conditions
Measure of psychiatric condition
Cardiovascular measurement
Sponsored by
Aalborg Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia, Cardiovascular disease, Premature mortality, Arteriosclerosis, Risk factor, Intervention, Treatment, Somatic morbidity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aalborg University Hospital, Psychiatric HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Debuting and chronic schizophrenia

Matched controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Existing psychiatric and somatic diagnosis and treatment - Self-report questionnaire
Measure of illness history with focus on previous diagnosis and treatment
Charlson Co-morbidity index - Self-report questionnaire
Measure of illness history with focus on which additional somatic or psychiatric diagnosis patients have.
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.
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.
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.
Clinical Global Impression Scale (CGI) - Clinical psychiatric evaluation
The CGI is a measure of symptom severity, therapeutic response and general improvement.
Echocardiography - Clinical objective evaluation
Echocardiography is a non-invasive procedure that uses ultrasound waves to generate live images of the patient's heart
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.
Pulmonary function test (PFT) - Clinical objective evaluation
PFT also known as spirometry is a procedure that measures lung function
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
Blood test - Clinical objective evaluation
Blood test is used to identify biomedical markers. A volume of 20 ml will be needed from each patient.
Body Composition analysis (BCA) - Clinical objective evaluation
Using a standard weight to measure body composition for each patient
CT-scan of upper abdomen (CTUA) - Clinical objective evaluation
CTUA uses X-rays to produce cross-sectional images of the heart and liver
Cardiovascular magnetic resonance imaging(CMR) - Clinical objective evaluation
CMR uses a strong magnetic field including radio waves to generate images of the heart
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.
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.

Full Information

First Posted
July 1, 2016
Last Updated
January 30, 2017
Sponsor
Aalborg Psychiatric Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02885792
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg Psychiatric Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cardiovascular Disease
Keywords
Schizophrenia, Cardiovascular disease, Premature mortality, Arteriosclerosis, Risk factor, Intervention, Treatment, Somatic morbidity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jørgen Aagaard, MD
Phone
97643626
Ext
45
Email
joaa@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Svend E. Jensen, MD
Email
svend.eggert.jensen@rn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svend E. Jensen, MD
Organizational Affiliation
Aalborg University Hospital, Psychiatric Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital, Psychiatric Hospital
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jørgen Aagaard, MD
Phone
97643626
Ext
45
Email
joaa@rn.dk
First Name & Middle Initial & Last Name & Degree
Svend E. Jensen, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34425769
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.
Results Reference
derived

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Coronary Artery Disease in Patients Suffering From Schizophrenia

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