Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Alcohol intake at baseline using The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaire |
The AUDIT-C is a validated 3-item questionnaire for identification of alcohol misuse. Each item has 5 possible responses, each scored from 0 to 4 points. Possible scores range from 0 to 12. The score cut-off for alcohol misuse is 4 points in men and 3 points in women |
Baseline |
|
| Other |
Average length of inpatient stay for schizophrenia related admissions |
The average length of inpatient stays will be reported as number of days and derived from the total number of days spent admitted over the total number of admissions. |
Baseline |
|
| Other |
Need of Care based on number of total hospital admission for schizophrenia |
Number of hospital admissions |
Baseline |
|
| Other |
Severity scoring of psychiatric symptoms using Clinical Global Impressions (CGI) Scale - Severity |
CGI for severity is a validated scale used to assess psychiatric illness severity by a clinician. Possible scores range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients) |
Baseline |
|
| Other |
Schizophrenia symptom severity as scored on the Positive and Negative Syndrome Scale (PANSS) |
PANSS/SCI-PANSS are validated clinician administered scale used to measure symptom severity in schizophrenia and consists of 30 items divided into 3 subscales: Positive Scale, Negative Scale and the General Pathology Scale. Each subscale can be scored from 1 (absent) to 7 (extreme). Possible scores for the Positive and Negative scales range from 7 - 49, and for the General Psychopathology Scale range from 16 - 112. The further developed SCI-PANSS (structured clinical interview - for the Positive and Negative Syndrome Scale). |
Baseline |
|
| Other |
Duration of schizophrenia |
Duration of schizophrenia as determined from self reported year of first episode of diagnosis/ or from date of diagnosis |
Baseline |
|
| Other |
Length of treatment with an antipsychotic medication |
The length of treatment with an antipsychotic medication will be reported in years |
Baseline |
|
| Other |
Antipsychotic dosage in daily equivalent dosage of chlorpromazine |
Antipsychotic dosages will also be converted to daily equivalent dosage of chlorpromazine for comparison across different medication will be reported in mg/day |
Baseline |
|
| Other |
Smoking status |
Number of participants who smoke will be reported in percent (%) |
Baseline |
|
| Other |
Waist Hip Ratio |
Waist Hip measurements will be reported as a ratio |
Baseline |
|
| Other |
Body Mass Index |
Body Mass Index, BMI will be derived from participants weight and height and reported as kg/m^2 |
Baseline |
|
| Other |
Body fat percent |
Body fat percent from body composition analysis will be reported in % |
Baseline |
|
| Other |
Physical Activity |
Baseline physical activity measured using the International Physical Activity Questionnaire (IPAQ) The IPAQ is validated in schizophrenia populations and the IPAQ has been validated in Norwegian populations. It is a self reported scoring system assessing physical activity over the last seven days. Physical activity can be then represented in minutes/week or MET-minutes/week. |
Baseline |
|
| Other |
Body muscle composition |
Body muscle mass will be reported in kg |
Baseline |
|
| Other |
Smoking history |
Smoking will be quantified and reported as pack/years |
Baseline |
|
| Other |
Age of participant |
Age of participant will be reported in years |
Baseline |
|
| Other |
Gender of participant |
Gender of participant will be reported as male or female |
Baseline |
|
| Primary |
Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography |
Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using Simpson's biplane method from 2D echocardiography. |
Baseline |
|
| Primary |
Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography |
Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using 3D echocardiography |
Baseline |
|
| Primary |
DISC1 mRNA quantification |
Measured from blood samples and reported as fold change |
Baseline |
|
| Primary |
Levels of high sensitive-CRP |
Levels of HS-CRP mg/L |
Baseline |
|
| Primary |
Levels of CK-MB |
Levels of CK-MB is reported in µg/L |
Baseline |
|
| Primary |
Levels of Troponin T |
Levels of Troponin T is reported in ng/L |
Baseline |
|
| Primary |
Levels of Troponin I |
Levels of Troponin I is reported in ng/L |
Baseline |
|
| Primary |
Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter |
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. |
Baseline |
|
| Primary |
Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter |
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. |
Baseline |
|
| Primary |
Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter |
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. |
Baseline |
|
| Primary |
Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter |
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. |
Baseline |
|
| Primary |
Left ventricular mass measured by echocardiography |
Left ventricular mass in grams (g) will be normalized against BSA in m^2 and reported as g/m ^2 |
Baseline |
|
| Primary |
Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography |
Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness will be reported in centimeters (cm) |
Baseline |
|
| Primary |
Fractional shortening measured by echocardiography |
Fractional shortening will be reported as a percentage (%) |
Baseline |
|
| Primary |
Global longitudinal strain (GLS), echocardiographic parameter |
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 (%) |
Baseline |
|
| Primary |
TAPSE echocardiographic parameter of right ventricular longitudinal systolic function |
TAPSE will be reported in millimeters (mm) |
baseline |
|
| Primary |
Echocardiographic parameter MPI, Myocardial performance index |
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). |
Baseline |
|
| Primary |
Echocardiographic parameter Mitral E/A ratio |
Mitral E/A ratio is derived from the ratio of the E wave velocity to the A wave velocity |
Baseline |
|
| Primary |
Echocardiography parameter of peak E velocity |
peak E velocity is reported in cm/s |
Baseline |
|
| Primary |
Echocardiography parameter of E wave deceleration time |
E wave deceleration time is reported in milliseconds (ms) |
Baseline |
|
| Primary |
Echocardiography parameter of ratio of E/e' |
The E/e' ratio is derived from the E wave velocity to the e' velocity |
Baseline |
|
| Primary |
Echocardiographic parameters septal e' and lateral e' velocities |
Septal e' and lateral e' velocities are reported as cm/s |
Baseline |
|
| Primary |
Echocardiographic parameter LAVI, left atrial volume indexed |
LAVI is reported in mL/m^2 and is the volume (mL) of the left atrium indexed against the BSA in m^2. |
Baseline |
|
| Primary |
Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity |
TRpV is reported in m/s |
Baseline |
|
| Primary |
Echocardiographic parameter, S wave velocity |
S wave velocity is the peak systolic velocity of the tricuspid annulus and is reported in cm/s |
Baseline |
|
| Primary |
Echocardiographic parameter, Indexed LV and RV stroke volumes |
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) |
Baseline |
|
| Primary |
Levels of NT-proBNP |
Levels of NT-proBNP from blood samples will be reported in ng/L |
Baseline |
|
| Primary |
Levels of IGF1 |
Levels of IGF1 from blood samples will be reported in nmol/L |
Baseline |
|
| Primary |
Levels of ANP |
Levels of ANP from blood samples will be reported in pg/mL |
Baseline |
|
| Primary |
Levels of BDNF, brain derived neurotrophic factor |
Levels of BDNF from blood samples will be reported in ng/mL |
Baseline |
|
| Primary |
Levels of Tumor Necrosis Factor alpha |
Levels of Tumor Necrosis Factor alpha from blood samples will be reported in pg/mL |
Baseline |
|
| Primary |
Levels of Transforming Growth Factor Beta |
Levels of Transforming Growth Factor Beta from blood samples will be reported in ng/mL |
Baseline |
|
| Primary |
Levels of cardiac Myosin-Binding Protein C |
Levels of cardiac Myosin-Binding Protein C from blood samples will be reported in ng/L |
Baseline |
|
| Primary |
Interleukin levels |
Interleukin levels from blood sample will be reported as pg/mL |
Baseline |
|
| Secondary |
native T1 time, cardiac MRI |
native myocardial T1 relaxation time is reported in milliseconds (ms) |
Baseline |
|
| Secondary |
Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI |
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) |
Baseline |
|
| Secondary |
Indexed LV mass, cardiac MRI |
Indexed LV mass will be reported in g/m^2 by indexing mass (g) to BSA (m^2) |
Baseline |
|
| Secondary |
LV Ejection Fraction, cardiac MRI |
LVEF will be reported in percent (%) |
Baseline |
|
| Secondary |
ECG corrected QT interval |
corrected QT interval will be reported in milliseconds (ms) |
Baseline |
|
| Secondary |
Number of participants with and abnormal ECG |
Number of participants with an abnormal ECG will be reported in % |
Baseline |
|
| Secondary |
Number of participants with abnormal liver function |
Number of participants with abnormal liver function will be reported as % |
Baseline |
|
| Secondary |
Number of participants with abnormal kidney function |
Number of participants with abnormal kidney function will be reported as % |
Baseline |
|
| Secondary |
Number of participants with abnormal thyroid function |
Number of participants with abnormal thyroid function will be reported as % |
Baseline |
|
| Secondary |
Number of participants with low Vitamin D levels |
Number of participants with low Vitamin D levels will be reported as % |
Baseline |
|
| Secondary |
Incidence of cardiovascular disease or mortality as registered in a health registry on follow up |
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 |
Within 15 years from start of study |
|
| Secondary |
Triglyceride levels |
Triglyceride will be reported in mmol/L |
Baseline |
|
| Secondary |
High-density lipoprotein, HDL-cholesterol levels |
HDL-cholesterol levels will be reported in mmol/L |
Baseline |
|
| Secondary |
Low-density lipoprotein, LDL-cholesterol levels |
LDL-cholesterol levels will be reported in mmol/L |
Baseline |
|
| Secondary |
Fasting glucose levels |
Fasting glucose levels will be reported in mmol/L |
Baseline |
|
| Secondary |
Glycated Hemoglobin (HbA1c) levels |
HbA1C will be reported in mmol/mol |
Baseline |
|
| Secondary |
Heart rate measured on ECG |
Heart rate measured on 12 lead ECG will be reported in beats per minute. |
Baseline |
|
| Secondary |
Systolic Blood Pressure |
Systolic Blood Pressure will be reported as mmHg |
Baseline |
|
| Secondary |
Diastolic Blood Pressure |
Diastolic Blood Pressure will be reported as mmHg |
Baseline |
|
| Secondary |
Lipoprotein a |
Lipoprotein a levels will be reported in mg/L |
Baseline |
|
| Secondary |
Magnesium levels |
Magnesium levels will be reported as mmol/L |
Baseline |
|
| Secondary |
Calcium levels |
Calcium levels will be reported as mmol/L |
Baseline |
|
| Secondary |
Sodium levels |
Sodium levels will be reported as mmol/L |
Baseline |
|
| Secondary |
Potassium levels |
Potassium levels will be reported as mmol/L |
Baseline |
|
