The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Echocardiography: ultrasound assessment of heart structure, volume and function

Cardiac Magnetic Resonance Imaging: MRI assessment of heart structure, volume, function and tissue characteristics

Electrocardiography: Assessment of cardiac rhythm and electrical activity

Blood sampling: To measure DISC1 mRNA expression and other potential biomarkers

Study summary

To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (2)

More Norwegian University of Science and Technology trials in Norway

Other trials for the same condition