Echocardiography
Diagnostic Testultrasound assessment of heart structure, volume and function
Other names: Echo
NCT Number: NCT06304233
To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
All sexes
Observational
Norwegian University of Science and Technology, Trondheim, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ultrasound assessment of heart structure, volume and function
Other names: Echo
MRI assessment of heart structure, volume, function and tissue characteristics
Other names: Cardiac MRI, CMRI
Assessment of cardiac rhythm and electrical activity
Other names: Holter, ECG
To measure DISC1 mRNA expression and other potential biomarkers
Time frame: Baseline
Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using Simpson's biplane method from 2D echocardiography.
Time frame: Baseline
Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using 3D echocardiography
Time frame: Baseline
Measured from blood samples and reported as fold change
Time frame: Baseline
Levels of HS-CRP mg/L
Time frame: Baseline
Levels of CK-MB is reported in µg/L
Time frame: Baseline
Levels of Troponin T is reported in ng/L
Time frame: Baseline
Levels of Troponin I is reported in ng/L
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Left ventricular mass in grams (g) will be normalized against BSA in m^2 and reported as g/m ^2
Time frame: Baseline
Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness will be reported in centimeters (cm)
Time frame: Baseline
Fractional shortening will be reported as a percentage (%)
Time frame: 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 (%)
Time frame: baseline
TAPSE will be reported in millimeters (mm)
Time frame: 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).
Time frame: Baseline
Mitral E/A ratio is derived from the ratio of the E wave velocity to the A wave velocity
Time frame: Baseline
peak E velocity is reported in cm/s
Time frame: Baseline
E wave deceleration time is reported in milliseconds (ms)
Time frame: Baseline
The E/e' ratio is derived from the E wave velocity to the e' velocity
Time frame: Baseline
Septal e' and lateral e' velocities are reported as cm/s
Time frame: Baseline
LAVI is reported in mL/m^2 and is the volume (mL) of the left atrium indexed against the BSA in m^2.
Time frame: Baseline
TRpV is reported in m/s
Time frame: Baseline
S wave velocity is the peak systolic velocity of the tricuspid annulus and is reported in cm/s
Time frame: 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)
Time frame: Baseline
Levels of NT-proBNP from blood samples will be reported in ng/L
Time frame: Baseline
Levels of IGF1 from blood samples will be reported in nmol/L
Time frame: Baseline
Levels of ANP from blood samples will be reported in pg/mL
Time frame: Baseline
Levels of BDNF from blood samples will be reported in ng/mL
Time frame: Baseline
Levels of Tumor Necrosis Factor alpha from blood samples will be reported in pg/mL
Time frame: Baseline
Levels of Transforming Growth Factor Beta from blood samples will be reported in ng/mL
Time frame: Baseline
Levels of cardiac Myosin-Binding Protein C from blood samples will be reported in ng/L
Time frame: Baseline
Interleukin levels from blood sample will be reported as pg/mL
Time frame: Baseline
native myocardial T1 relaxation time is reported in milliseconds (ms)
Time frame: 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)
Time frame: Baseline
Indexed LV mass will be reported in g/m^2 by indexing mass (g) to BSA (m^2)
Time frame: Baseline
LVEF will be reported in percent (%)
Time frame: Baseline
corrected QT interval will be reported in milliseconds (ms)
Time frame: Baseline
Number of participants with an abnormal ECG will be reported in %
Time frame: Baseline
Number of participants with abnormal liver function will be reported as %
Time frame: Baseline
Number of participants with abnormal kidney function will be reported as %
Time frame: Baseline
Number of participants with abnormal thyroid function will be reported as %
Time frame: Baseline
Number of participants with low Vitamin D levels will be reported as %
Time frame: 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
Time frame: Baseline
Triglyceride will be reported in mmol/L
Time frame: Baseline
HDL-cholesterol levels will be reported in mmol/L
Time frame: Baseline
LDL-cholesterol levels will be reported in mmol/L
Time frame: Baseline
Fasting glucose levels will be reported in mmol/L
Time frame: Baseline
HbA1C will be reported in mmol/mol
Time frame: Baseline
Heart rate measured on 12 lead ECG will be reported in beats per minute.
Time frame: Baseline
Systolic Blood Pressure will be reported as mmHg
Time frame: Baseline
Diastolic Blood Pressure will be reported as mmHg
Time frame: Baseline
Lipoprotein a levels will be reported in mg/L
Time frame: Baseline
Magnesium levels will be reported as mmol/L
Time frame: Baseline
Calcium levels will be reported as mmol/L
Time frame: Baseline
Sodium levels will be reported as mmol/L
Time frame: Baseline
Potassium levels will be reported as mmol/L
Time frame: Baseline
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
Time frame: Baseline
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.
Time frame: Baseline
Number of hospital admissions
Time frame: Baseline
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)
Time frame: Baseline
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).
Time frame: Baseline
Duration of schizophrenia as determined from self reported year of first episode of diagnosis/ or from date of diagnosis
Time frame: Baseline
The length of treatment with an antipsychotic medication will be reported in years
Time frame: Baseline
Antipsychotic dosages will also be converted to daily equivalent dosage of chlorpromazine for comparison across different medication will be reported in mg/day
Time frame: Baseline
Number of participants who smoke will be reported in percent (%)
Time frame: Baseline
Waist Hip measurements will be reported as a ratio
Time frame: Baseline
Body Mass Index, BMI will be derived from participants weight and height and reported as kg/m^2
Time frame: Baseline
Body fat percent from body composition analysis will be reported in %
Time frame: Baseline
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.
Time frame: Baseline
Body muscle mass will be reported in kg
Time frame: Baseline
Smoking will be quantified and reported as pack/years
Time frame: Baseline
Age of participant will be reported in years
Time frame: Baseline
Gender of participant will be reported as male or female
Norwegian University of Science and Technology
Other
The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease - The Link Between DISC1 and Cardiac Function in Patients With Schizophrenia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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