AzTrials
AzTrials

SchizophreniaNCT02885792

Coronary Artery Disease in Patients Suffering From Schizophrenia

A study testing Illness history, Measure of social conditions and Measure of psychiatric condition in people with Schizophrenia and Cardiovascular Disease, run by Aalborg Psychiatric Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Schizophrenia, Cardiovascular Disease
What is being tested?
Illness history, Measure of social conditions and Measure of psychiatric condition
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteDenmark
Study dates
Sep 2015to Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with a diagnosis of F20 schizophrenia.
  • Informed statement of consent
  • Age > 18

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jørgen Aagaard, MD contact

97643626 ext. 45

joaa@rn.dk

Svend E. Jensen, MD contact

svend.eggert.jensen@rn.dk

Denmark1 site, 1 recruiting

  • Aalborg University Hospital, Psychiatric Hospital

    Aalborg, DK-9000

    Jørgen Aagaard, MD, 97643626 ext. 45, joaa@rn.dk

    Svend E. Jensen, MD, PhD

    Recruiting

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Illness history, Measure of social conditions, Measure of psychiatric condition, Cardiovascular measurement
Keywords
Schizophrenia, Cardiovascular disease, Premature mortality, Arteriosclerosis, Risk factor, Intervention, Treatment, Somatic morbidity
Medical subject headings
Schizophrenia, Cardiovascular Diseases, Arteriosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Illness historyOther

    Existing psychiatric and somatic diagnosis and treatment. Charlson co-morbidity Index.

  • Measure of social conditionsOther

    A self-report questionnaire measuring social isolation, including relations to family and friends.

  • Measure of psychiatric conditionOther

    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.

  • Cardiovascular measurementProcedure or surgery

    This procedure is used to detect early identification of cardiovascular disease progression.

Study groups in NCT02885792
Study groupRoleWhat they receive
Debuting and chronic schizophreniaExperimentalILLNESS 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
Receives: Other: Illness history; Other: Measure of social conditions; Other: Measure of psychiatric condition; Procedure: Cardiovascular measurement
Matched controlsActive comparatorCARDIOVASCULAR 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
Receives: Procedure: Cardiovascular measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 years

Secondary outcomes (16)

  1. Existing psychiatric and somatic diagnosis and treatment - Self-report questionnaire

    Measure of illness history with focus on previous diagnosis and treatment

    Measured: 6 years

  2. Charlson Co-morbidity index - Self-report questionnaire

    Measure of illness history with focus on which additional somatic or psychiatric diagnosis patients have.

    Measured: 6 years

  3. 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.

    Measured: 6 years

  4. 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.

    Measured: 6 years

  5. 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.

    Measured: 6 years

  6. Clinical Global Impression Scale (CGI) - Clinical psychiatric evaluation

    The CGI is a measure of symptom severity, therapeutic response and general improvement.

    Measured: 6 years

  7. Echocardiography - Clinical objective evaluation

    Echocardiography is a non-invasive procedure that uses ultrasound waves to generate live images of the patient's heart

    Measured: 6 years

  8. 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.

    Measured: 6 years

  9. Pulmonary function test (PFT) - Clinical objective evaluation

    PFT also known as spirometry is a procedure that measures lung function

    Measured: 6 years

  10. 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

    Measured: 6 years

  11. Blood test - Clinical objective evaluation

    Blood test is used to identify biomedical markers. A volume of 20 ml will be needed from each patient.

    Measured: 6 years

  12. Body Composition analysis (BCA) - Clinical objective evaluation

    Using a standard weight to measure body composition for each patient

    Measured: 6 years

  13. CT-scan of upper abdomen (CTUA) - Clinical objective evaluation

    CTUA uses X-rays to produce cross-sectional images of the heart and liver

    Measured: 6 years

  14. Cardiovascular magnetic resonance imaging(CMR) - Clinical objective evaluation

    CMR uses a strong magnetic field including radio waves to generate images of the heart

    Measured: 6 years

  15. 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.

    Measured: 6 years

  16. 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.

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2019 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02885792
Sponsor's protocol ID
N-20140047
Status last verified
Jan 2017
First submitted
1 Jul 2016
Last updated
31 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Jorgensen LR, Hegtmann CL, Straszek SPV, Hoyer C, Polcwiartek C, Petersen LJ, Dalgaard MK, Jensen SE, Nielsen RE. Peripheral artery disease in patients with schizophrenia as compared to controls. BMC Cardiovasc Disord. 2023 Mar 8;23(1):126. doi: 10.1186/s12872-023-03143-9.

    PubMed 36890440

  • 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.

    PubMed 34425769

Questions about this trial

What is this clinical trial studying?

A study testing Illness history, Measure of social conditions and Measure of psychiatric condition in people with Schizophrenia and Cardiovascular Disease, run by Aalborg Psychiatric Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jørgen Aagaard, MD (97643626 ext. 45, joaa@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CT coronary angiography - a quantitative clinical measurement (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02885792, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.

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