protocolSection identificationModule nctId: NCT06304233, orgStudyIdInfo id: 606103, briefTitle: The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2038-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Norwegian University of Science and Technology, class: OTHER, collaborators name: St. Olavs Hospital, descriptionModule briefSummary: To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia., conditionsModule conditions: Heart Diseases, conditions: Heart; Functional Disturbance, conditions: Schizophrenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Echocardiography, interventions name: Cardiac Magnetic Resonance Imaging, interventions name: Electrocardiography, interventions name: Blood sampling, outcomesModule primaryOutcomes measure: Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography, primaryOutcomes measure: Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography, primaryOutcomes measure: DISC1 mRNA quantification, primaryOutcomes measure: Levels of high sensitive-CRP, primaryOutcomes measure: Levels of CK-MB, primaryOutcomes measure: Levels of Troponin T, primaryOutcomes measure: Levels of Troponin I, primaryOutcomes measure: Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter, primaryOutcomes measure: Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter, primaryOutcomes measure: Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter, primaryOutcomes measure: Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter, primaryOutcomes measure: Left ventricular mass measured by echocardiography, primaryOutcomes measure: Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography, primaryOutcomes measure: Fractional shortening measured by echocardiography, primaryOutcomes measure: Global longitudinal strain (GLS), echocardiographic parameter, primaryOutcomes measure: TAPSE echocardiographic parameter of right ventricular longitudinal systolic function, primaryOutcomes measure: Echocardiographic parameter MPI, Myocardial performance index, primaryOutcomes measure: Echocardiographic parameter Mitral E/A ratio, primaryOutcomes measure: Echocardiography parameter of peak E velocity, primaryOutcomes measure: Echocardiography parameter of E wave deceleration time, primaryOutcomes measure: Echocardiography parameter of ratio of E/e', primaryOutcomes measure: Echocardiographic parameters septal e' and lateral e' velocities, primaryOutcomes measure: Echocardiographic parameter LAVI, left atrial volume indexed, primaryOutcomes measure: Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity, primaryOutcomes measure: Echocardiographic parameter, S wave velocity, primaryOutcomes measure: Echocardiographic parameter, Indexed LV and RV stroke volumes, primaryOutcomes measure: Levels of NT-proBNP, primaryOutcomes measure: Levels of IGF1, primaryOutcomes measure: Levels of ANP, primaryOutcomes measure: Levels of BDNF, brain derived neurotrophic factor, primaryOutcomes measure: Levels of Tumor Necrosis Factor alpha, primaryOutcomes measure: Levels of Transforming Growth Factor Beta, primaryOutcomes measure: Levels of cardiac Myosin-Binding Protein C, primaryOutcomes measure: Interleukin levels, secondaryOutcomes measure: native T1 time, cardiac MRI, secondaryOutcomes measure: Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI, secondaryOutcomes measure: Indexed LV mass, cardiac MRI, secondaryOutcomes measure: LV Ejection Fraction, cardiac MRI, secondaryOutcomes measure: ECG corrected QT interval, secondaryOutcomes measure: Number of participants with and abnormal ECG, secondaryOutcomes measure: Number of participants with abnormal liver function, secondaryOutcomes measure: Number of participants with abnormal kidney function, secondaryOutcomes measure: Number of participants with abnormal thyroid function, secondaryOutcomes measure: Number of participants with low Vitamin D levels, secondaryOutcomes measure: Incidence of cardiovascular disease or mortality as registered in a health registry on follow up, secondaryOutcomes measure: Triglyceride levels, secondaryOutcomes measure: High-density lipoprotein, HDL-cholesterol levels, secondaryOutcomes measure: Low-density lipoprotein, LDL-cholesterol levels, secondaryOutcomes measure: Fasting glucose levels, secondaryOutcomes measure: Glycated Hemoglobin (HbA1c) levels, secondaryOutcomes measure: Heart rate measured on ECG, secondaryOutcomes measure: Systolic Blood Pressure, secondaryOutcomes measure: Diastolic Blood Pressure, secondaryOutcomes measure: Lipoprotein a, secondaryOutcomes measure: Magnesium levels, secondaryOutcomes measure: Calcium levels, secondaryOutcomes measure: Sodium levels, secondaryOutcomes measure: Potassium levels, otherOutcomes measure: Alcohol intake at baseline using The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaire, otherOutcomes measure: Average length of inpatient stay for schizophrenia related admissions, otherOutcomes measure: Need of Care based on number of total hospital admission for schizophrenia, otherOutcomes measure: Severity scoring of psychiatric symptoms using Clinical Global Impressions (CGI) Scale - Severity, otherOutcomes measure: Schizophrenia symptom severity as scored on the Positive and Negative Syndrome Scale (PANSS), otherOutcomes measure: Duration of schizophrenia, otherOutcomes measure: Length of treatment with an antipsychotic medication, otherOutcomes measure: Antipsychotic dosage in daily equivalent dosage of chlorpromazine, otherOutcomes measure: Smoking status, otherOutcomes measure: Waist Hip Ratio, otherOutcomes measure: Body Mass Index, otherOutcomes measure: Body fat percent, otherOutcomes measure: Physical Activity, otherOutcomes measure: Body muscle composition, otherOutcomes measure: Smoking history, otherOutcomes measure: Age of participant, otherOutcomes measure: Gender of participant, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Norwegian University of Science and Technology, status: RECRUITING, city: Trondheim, country: Norway, contacts name: Morten A Høydal, PhD, role: CONTACT, phone: +47 48134843, email: morten.hoydal@ntnu.no, contacts name: Rita Brekke, MD, MSc, role: CONTACT, phone: +47 45111574, email: rita.brekke@ntnu.no, geoPoint lat: 63.43049, lon: 10.39506, locations facility: St Olavs Hospital, Trondheim University Hospital, status: RECRUITING, city: Trondheim, country: Norway, contacts name: Mette E Tunset, MD, role: CONTACT, email: mette.elise.tunset@stolav.no, contacts name: Morten B Schou, PhD, role: CONTACT, email: morten.brix.schou@stolav.no, geoPoint lat: 63.43049, lon: 10.39506, hasResults: False