Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-03-07 @ 9:30 PM
Study NCT ID:
NCT02885792
Status:
UNKNOWN
Last Update Posted:
2017-01-31
First Post:
2016-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary Artery Disease in Patients Suffering From Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2016-07-01', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CT coronary angiography - a quantitative clinical measurement', 'timeFrame': '6 years', 'description': 'CT coronary angiography is a non-invasive procedure that uses simple CT-scan without contrast to measure coronary calcifications'}], 'secondaryOutcomes': [{'measure': 'Existing psychiatric and somatic diagnosis and treatment - Self-report questionnaire', 'timeFrame': '6 years', 'description': 'Measure of illness history with focus on previous diagnosis and treatment'}, {'measure': 'Charlson Co-morbidity index - Self-report questionnaire', 'timeFrame': '6 years', 'description': 'Measure of illness history with focus on which additional somatic or psychiatric diagnosis patients have.'}, {'measure': 'Lubben Social Network Scale-6 (LSNS-6) - Self-report questionnaire', 'timeFrame': '6 years', 'description': 'The LSNS-6 is a self-report questionnaire measuring social isolation, including relations to family and friends.'}, {'measure': 'Global Assessment of Functioning (GAF) - Clinical evaluation', 'timeFrame': '6 years', '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."}, {'measure': 'Positive and Negative Syndrome Scale (PANNS) - Clinical psychiatric evaluation', 'timeFrame': '6 years', '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.'}, {'measure': 'Clinical Global Impression Scale (CGI) - Clinical psychiatric evaluation', 'timeFrame': '6 years', 'description': 'The CGI is a measure of symptom severity, therapeutic response and general improvement.'}, {'measure': 'Echocardiography - Clinical objective evaluation', 'timeFrame': '6 years', 'description': "Echocardiography is a non-invasive procedure that uses ultrasound waves to generate live images of the patient's heart"}, {'measure': 'Heart rate variability (HRV) - Clinical objective evaluation', 'timeFrame': '6 years', 'description': 'HRV is a non-invasive procedure that detects the function of the autonomic nervous system on the heart rhythm.'}, {'measure': 'Pulmonary function test (PFT) - Clinical objective evaluation', 'timeFrame': '6 years', 'description': 'PFT also known as spirometry is a procedure that measures lung function'}, {'measure': 'Toe brachial index (TBI) - Clinical objective evaluation', 'timeFrame': '6 years', 'description': 'TBP is a procedure that measures the relationship between the systolic blood pressure at the toe and the arm'}, {'measure': 'Blood test - Clinical objective evaluation', 'timeFrame': '6 years', 'description': 'Blood test is used to identify biomedical markers. A volume of 20 ml will be needed from each patient.'}, {'measure': 'Body Composition analysis (BCA) - Clinical objective evaluation', 'timeFrame': '6 years', 'description': 'Using a standard weight to measure body composition for each patient'}, {'measure': 'CT-scan of upper abdomen (CTUA) - Clinical objective evaluation', 'timeFrame': '6 years', 'description': 'CTUA uses X-rays to produce cross-sectional images of the heart and liver'}, {'measure': 'Cardiovascular magnetic resonance imaging(CMR) - Clinical objective evaluation', 'timeFrame': '6 years', 'description': 'CMR uses a strong magnetic field including radio waves to generate images of the heart'}, {'measure': 'Adipose tissue biopsy - Clinical objective evaluation', 'timeFrame': '6 years', '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.'}, {'measure': 'Urine sample - Objective clinical evaluation', 'timeFrame': '6 years', 'description': 'Urine sample measures the content of melatonin, which is a hormone that controls the natural cycle of sleeping and waking hours.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Cardiovascular disease', 'Premature mortality', 'Arteriosclerosis', 'Risk factor', 'Intervention', 'Treatment', 'Somatic morbidity'], 'conditions': ['Schizophrenia', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '36890440', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34425769', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with a diagnosis of F20 schizophrenia.\n* Informed statement of consent\n* Age \\> 18\n\nExclusion Criteria:\n\n* Incompetency to create stabile relation or make agreements\n* Pregnancy and also breastfeeding women\n* Participants with severe claustrophobia\n* Participants with lack of ability to cooperate with the planned study program.'}, 'identificationModule': {'nctId': 'NCT02885792', 'briefTitle': 'Coronary Artery Disease in Patients Suffering From Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Coronary Artery Disease as a Cause of Morbidity and Mortality in Patients Suffering From Schizophrenia: Epidemiology and Status to Provide Prevention, Interventions and Treatment', 'orgStudyIdInfo': {'id': 'N-20140047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Debuting and chronic schizophrenia', 'description': 'ILLNESS HISTORY:\n\n* Existing psychiatric and somatic diagnosis and treatment\n* Charlson co-morbidity\n\nMEASURE OF SOCIAL CONDITIONS\n\n\\- For example Lubben Social Network Scale-6 and Brief Trauma Questionnaire.\n\nMEASURE OF PSYCHIATRIC CONDITION::\n\n* Positive and Negative Syndrome Scale (PANSS)\n* Clinical Global Impression Scale (CGI)\n* Columbia Suicide Severity Rating Scale (C-SSRS)\n* Beck Cognitive Insight Scale\n* Birchwood Insight Scale\n\nCARDIOVASCULAR MEASUREMENT:\n\nCT Coronary angiography (CT-CAG)\n\n* Echocardiography\n* Heart rate variability (HRV)\n* Pulmonary function test (PFT)\n* Toe blood pressure (TBP)\n* Blood test\n* Body composition analysis\n* CT scan of upper abdomen\n* Cardiovascular magnetic resonance imaging (CMR)\n* Adipose tissue biopsy', 'interventionNames': ['Other: Illness history', 'Other: Measure of social conditions', 'Other: Measure of psychiatric condition', 'Procedure: Cardiovascular measurement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Matched controls', 'description': 'CARDIOVASCULAR MEASUREMENT:\n\n* CT Coronary angiography (CT-CAG)\n* Echocardiography\n* Heart rate variability (HRV)\n* Pulmonary function test (PFT)\n* Toe blood pressure (TBP)\n* Blood test\n* Body composition analysis\n* CT scan of upper abdomen\n* Cardiovascular magnetic resonance imaging (CMR)\n* Adipose tissue biopsy', 'interventionNames': ['Procedure: Cardiovascular measurement']}], 'interventions': [{'name': 'Illness history', 'type': 'OTHER', 'description': 'Existing psychiatric and somatic diagnosis and treatment. Charlson co-morbidity Index.', 'armGroupLabels': ['Debuting and chronic schizophrenia']}, {'name': 'Measure of social conditions', 'type': 'OTHER', 'description': 'A self-report questionnaire measuring social isolation, including relations to family and friends.', 'armGroupLabels': ['Debuting and chronic schizophrenia']}, {'name': 'Measure of psychiatric condition', 'type': 'OTHER', '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.', 'armGroupLabels': ['Debuting and chronic schizophrenia']}, {'name': 'Cardiovascular measurement', 'type': 'PROCEDURE', 'description': 'This procedure is used to detect early identification of cardiovascular disease progression.', 'armGroupLabels': ['Debuting and chronic schizophrenia', 'Matched controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-9000', 'city': 'Aalborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jørgen Aagaard, MD', 'role': 'CONTACT', 'email': 'joaa@rn.dk', 'phone': '97643626', 'phoneExt': '45'}, {'name': 'Svend E. Jensen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aalborg University Hospital, Psychiatric Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'centralContacts': [{'name': 'Jørgen Aagaard, MD', 'role': 'CONTACT', 'email': 'joaa@rn.dk', 'phone': '97643626', 'phoneExt': '45'}, {'name': 'Svend E. Jensen, MD', 'role': 'CONTACT', 'email': 'svend.eggert.jensen@rn.dk'}], 'overallOfficials': [{'name': 'Svend E. Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital, Psychiatric Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg Psychiatric Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief consultant, Professor, Dr.Med.Sci.', 'investigatorFullName': 'Jørgen Aagaard', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}