Heart Diseases, Heart; Functional Disturbance, Schizophrenia
Conditions
Keywords
Disrupted in Schizophrenia 1, DISC1, Cardiac Biomarker
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.
Interventions
DIAGNOSTIC_TESTEchocardiography
ultrasound assessment of heart structure, volume and function
DIAGNOSTIC_TESTCardiac Magnetic Resonance Imaging
MRI assessment of heart structure, volume, function and tissue characteristics
DIAGNOSTIC_TESTElectrocardiography
Assessment of cardiac rhythm and electrical activity
OTHERBlood sampling
To measure DISC1 mRNA expression and other potential biomarkers
Sponsors
Norwegian University of Science and Technology
St. Olavs Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with ICD-10 schizophrenia, schizotypal or delusional disorders (F20 to F29) * Both inpatient and outpatient * Capable of giving informed consent
Exclusion criteria
* Current or previous diagnosis of cancer * Current or previous treatment with chemotherapy * Current pregnancy * Mothers less than 6 months post-partum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| Levels of Troponin T | Baseline | Levels of Troponin T is reported in ng/L |
| Levels of Troponin I | Baseline | Levels of Troponin I is reported in ng/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. |
| 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. |
| 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 |
| 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) |
| 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 (%) |
| TAPSE echocardiographic parameter of right ventricular longitudinal systolic function | baseline | TAPSE will be reported in millimeters (mm) |
| 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 |
| 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) |
| Echocardiography parameter of ratio of E/e' | Baseline | The E/e' ratio is derived from the E wave velocity to the e' velocity |
| Echocardiographic parameters septal e' and lateral e' velocities | Baseline | Septal e' and lateral e' velocities are reported as cm/s |
| 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 TRpV, Tricuspid Regurgitation peak Velocity | Baseline | TRpV is reported in m/s |
| Echocardiographic parameter, S wave velocity | Baseline | S wave velocity is the peak systolic velocity of the tricuspid annulus and is reported in cm/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) |
| Levels of NT-proBNP | Baseline | Levels of NT-proBNP from blood samples will be reported in ng/L |
| Levels of IGF1 | Baseline | Levels of IGF1 from blood samples will be reported in nmol/L |
| Levels of ANP | Baseline | Levels of ANP from blood samples will be reported in pg/mL |
| Levels of BDNF, brain derived neurotrophic factor | Baseline | Levels of BDNF from blood samples will be reported in ng/mL |
| Levels of Tumor Necrosis Factor alpha | Baseline | Levels of Tumor Necrosis Factor alpha from blood samples will be reported in pg/mL |
| Levels of Transforming Growth Factor Beta | Baseline | Levels of Transforming Growth Factor Beta from blood samples will be reported in ng/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 |
| Interleukin levels | Baseline | Interleukin levels from blood sample will be reported as pg/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| native T1 time, cardiac MRI | Baseline | native myocardial T1 relaxation time is reported in milliseconds (ms) |
| 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) |
| Indexed LV mass, cardiac MRI | Baseline | Indexed LV mass will be reported in g/m\^2 by indexing mass (g) 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) |
| Number of participants with and abnormal ECG | Baseline | Number of participants with an abnormal ECG will be reported in % |
| 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 abnormal thyroid function | Baseline | Number of participants with abnormal thyroid 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 % |
| 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 |
| Triglyceride levels | Baseline | Triglyceride will be reported in mmol/L |
| 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 |
| 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 |
| Heart rate measured on ECG | Baseline | Heart rate measured on 12 lead ECG will be reported in beats per minute. |
| Systolic Blood Pressure | Baseline | Systolic Blood Pressure will be reported as mmHg |
| 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 |
| Potassium levels | Baseline | Potassium levels will be reported as mmol/L |
Countries
Norway
Contacts
STUDY_DIRECTORMorten A Høydal, PhD
Norwegian University of Science and Technology
Outcome results
None listed