The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease
- Conditions
- SchizophreniaHeart DiseasesHeart; Functional Disturbance
- Interventions
- Diagnostic Test: EchocardiographyDiagnostic Test: Cardiac Magnetic Resonance ImagingDiagnostic Test: ElectrocardiographyOther: Blood sampling
- Registration Number
- NCT06304233
- Lead Sponsor
- Norwegian University of Science and Technology
- Brief Summary
To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia.
- Detailed Description
Potential participants interested in the study will be screened for eligibility. Those who meet the eligibility criteria will be informed about the study, the expected investigations and its potential risks. All participants giving written informed consent will be enrolled into the study. Participants will be interviewed, given questionnaires, have blood and/or skin samples and clinical parameters taken. Cardiac function parameters will be measured using electrocardiography, echocardiography and magnetic resonance imaging.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Patients with ICD-10 schizophrenia, schizotypal or delusional disorders (F20 to F29)
- Both inpatient and outpatient
- Capable of giving informed consent
- Current or previous diagnosis of cancer
- Current or previous treatment with chemotherapy
- Current pregnancy
- Mothers less than 6 months post-partum
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Diagnosed with Schizophrenia Electrocardiography Patients with a ICD-10 diagnosis of Schizophrenia will undergo investigations to assess cardiac function, cardiovascular disease risk factors and DISC1 mRNA expression. Participants eligible for MRI will be invited to undergo cardiac MRI in addition to echocardiography. No mental health diagnosis Cardiac Magnetic Resonance Imaging Participants without a mental health diagnosis will be randomly selected from an existing population registered in the HUNT data and biobank for whom, echocardiographic data and biological samples are available.Those enrolled as controls will be invited to participate in the cardiac MRI portion of the study. No mental health diagnosis Electrocardiography Participants without a mental health diagnosis will be randomly selected from an existing population registered in the HUNT data and biobank for whom, echocardiographic data and biological samples are available.Those enrolled as controls will be invited to participate in the cardiac MRI portion of the study. Diagnosed with Schizophrenia Echocardiography Patients with a ICD-10 diagnosis of Schizophrenia will undergo investigations to assess cardiac function, cardiovascular disease risk factors and DISC1 mRNA expression. Participants eligible for MRI will be invited to undergo cardiac MRI in addition to echocardiography. Diagnosed with Schizophrenia Cardiac Magnetic Resonance Imaging Patients with a ICD-10 diagnosis of Schizophrenia will undergo investigations to assess cardiac function, cardiovascular disease risk factors and DISC1 mRNA expression. Participants eligible for MRI will be invited to undergo cardiac MRI in addition to echocardiography. Diagnosed with Schizophrenia Blood sampling Patients with a ICD-10 diagnosis of Schizophrenia will undergo investigations to assess cardiac function, cardiovascular disease risk factors and DISC1 mRNA expression. Participants eligible for MRI will be invited to undergo cardiac MRI in addition to echocardiography. No mental health diagnosis Echocardiography Participants without a mental health diagnosis will be randomly selected from an existing population registered in the HUNT data and biobank for whom, echocardiographic data and biological samples are available.Those enrolled as controls will be invited to participate in the cardiac MRI portion of the study. No mental health diagnosis Blood sampling Participants without a mental health diagnosis will be randomly selected from an existing population registered in the HUNT data and biobank for whom, echocardiographic data and biological samples are available.Those enrolled as controls will be invited to participate in the cardiac MRI portion of the study.
- Primary Outcome Measures
Name Time Method Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography Baseline Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using Simpson's biplane method from 2D echocardiography.
Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter Baseline RV EDV in mL will be normalized against body surface area (BSA) in m\^2 to report RV EDV normalized by BSA in mL/m\^2.
Fractional shortening measured by echocardiography Baseline Fractional shortening will be reported as a percentage (%)
Global longitudinal strain (GLS), echocardiographic parameter Baseline GLS(%) = (MLs - MLd)/MLd, where MLs is myocardial length at end-systole and MLd is the myocardial length at end-diastole. GLS will be reported in precentage (%)
Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity Baseline TRpV is reported in m/s
Echocardiographic parameter, Indexed LV and RV stroke volumes Baseline Indexed LV stroke volume and Indexed RV stroke volume will be reported in mL/m\^2 by by indexing the volumes (mL) to BSA (m\^2)
Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography Baseline Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using 3D echocardiography
Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography Baseline Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness will be reported in centimeters (cm)
Echocardiography parameter of ratio of E/e' Baseline The E/e' ratio is derived from the E wave velocity to the e' velocity
Levels of NT-proBNP Baseline Levels of NT-proBNP from blood samples will be reported in ng/L
DISC1 mRNA quantification Baseline Measured from blood samples and reported as fold change
Levels of high sensitive-CRP Baseline Levels of HS-CRP mg/L
Levels of CK-MB Baseline Levels of CK-MB is reported in µg/L
Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter Baseline LV EDV in milliliters (mL) will be normalized against body surface area (BSA) in m\^2 to report LV EDV normalized by BSA in mL/m\^2.
TAPSE echocardiographic parameter of right ventricular longitudinal systolic function baseline TAPSE will be reported in millimeters (mm)
Echocardiographic parameters septal e' and lateral e' velocities Baseline Septal e' and lateral e' velocities are reported as cm/s
Levels of Troponin I Baseline Levels of Troponin I is reported in ng/L
Echocardiographic parameter MPI, Myocardial performance index Baseline MPI is a unitless index derived from the sum of the isovolumic relaxation time (IVRT) and the isovolumic contraction time (IVCT) in milliseconds (ms) divided by the ejection time interval in (ms).
Echocardiographic parameter Mitral E/A ratio Baseline Mitral E/A ratio is derived from the ratio of the E wave velocity to the A wave velocity
Levels of IGF1 Baseline Levels of IGF1 from blood samples will be reported in nmol/L
Levels of BDNF, brain derived neurotrophic factor Baseline Levels of BDNF from blood samples will be reported in ng/mL
Levels of Transforming Growth Factor Beta Baseline Levels of Transforming Growth Factor Beta from blood samples will be reported in ng/mL
Interleukin levels Baseline Interleukin levels from blood sample will be reported as pg/mL
Levels of Troponin T Baseline Levels of Troponin T is reported in ng/L
Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter Baseline LV ESV in mL will be normalized against body surface area (BSA) in m\^2 to report LV ESV normalized by BSA in mL/m\^2.
Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter Baseline RV ESV in mL will be normalized against body surface area (BSA) in m\^2 to report RV ESV normalized by BSA in mL/m\^2.
Left ventricular mass measured by echocardiography Baseline Left ventricular mass in grams (g) will be normalized against BSA in m\^2 and reported as g/m \^2
Echocardiography parameter of peak E velocity Baseline peak E velocity is reported in cm/s
Echocardiography parameter of E wave deceleration time Baseline E wave deceleration time is reported in milliseconds (ms)
Levels of Tumor Necrosis Factor alpha Baseline Levels of Tumor Necrosis Factor alpha from blood samples will be reported in pg/mL
Echocardiographic parameter LAVI, left atrial volume indexed Baseline LAVI is reported in mL/m\^2 and is the volume (mL) of the left atrium indexed against the BSA in m\^2.
Echocardiographic parameter, S wave velocity Baseline S wave velocity is the peak systolic velocity of the tricuspid annulus and is reported in cm/s
Levels of ANP Baseline Levels of ANP from blood samples will be reported in pg/mL
Levels of cardiac Myosin-Binding Protein C Baseline Levels of cardiac Myosin-Binding Protein C from blood samples will be reported in ng/L
- Secondary Outcome Measures
Name Time Method Number of participants with and abnormal ECG Baseline Number of participants with an abnormal ECG will be reported in %
Incidence of cardiovascular disease or mortality as registered in a health registry on follow up Within 15 years from start of study Extraction of information from the cardiovascular disease registry and deaths registry between 10 - 15 years from the start of the study to determine incidence of cardiovascular disease outcomes for the study cohort
Systolic Blood Pressure Baseline Systolic Blood Pressure will be reported as mmHg
Potassium levels Baseline Potassium levels will be reported as mmol/L
Indexed LV mass, cardiac MRI Baseline Indexed LV mass will be reported in g/m\^2 by indexing mass (g) to BSA (m\^2)
Number of participants with abnormal liver function Baseline Number of participants with abnormal liver function will be reported as %
Number of participants with abnormal kidney function Baseline Number of participants with abnormal kidney function will be reported as %
Number of participants with low Vitamin D levels Baseline Number of participants with low Vitamin D levels will be reported as %
native T1 time, cardiac MRI Baseline native myocardial T1 relaxation time is reported in milliseconds (ms)
High-density lipoprotein, HDL-cholesterol levels Baseline HDL-cholesterol levels will be reported in mmol/L
Low-density lipoprotein, LDL-cholesterol levels Baseline LDL-cholesterol levels will be reported in mmol/L
Diastolic Blood Pressure Baseline Diastolic Blood Pressure will be reported as mmHg
Lipoprotein a Baseline Lipoprotein a levels will be reported in mg/L
Magnesium levels Baseline Magnesium levels will be reported as mmol/L
Calcium levels Baseline Calcium levels will be reported as mmol/L
Sodium levels Baseline Sodium levels will be reported as mmol/L
Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI Baseline Indexed LV and RV end-diastolic, end-systolic and stroke volumes will be reported in mL/m\^2, by indexing the volumes (mL) to BSA (m\^2)
LV Ejection Fraction, cardiac MRI Baseline LVEF will be reported in percent (%)
ECG corrected QT interval Baseline corrected QT interval will be reported in milliseconds (ms)
Triglyceride levels Baseline Triglyceride will be reported in mmol/L
Heart rate measured on ECG Baseline Heart rate measured on 12 lead ECG will be reported in beats per minute.
Number of participants with abnormal thyroid function Baseline Number of participants with abnormal thyroid function will be reported as %
Fasting glucose levels Baseline Fasting glucose levels will be reported in mmol/L
Glycated Hemoglobin (HbA1c) levels Baseline HbA1C will be reported in mmol/mol
Trial Locations
- Locations (2)
Norwegian University of Science and Technology
🇳🇴Trondheim, Norway
St Olavs Hospital, Trondheim University Hospital
🇳🇴Trondheim, Norway