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
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography
研究概览
简要总结
To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ICD-10 schizophrenia, schizotypal or delusional disorders (F20 to F29)
- •Both inpatient and outpatient
- •Capable of giving informed consent
排除标准
- •Current or previous diagnosis of cancer
- •Current or previous treatment with chemotherapy
- •Current pregnancy
- •Mothers less than 6 months post-partum
结局指标
主要结局
Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography
时间窗: 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
时间窗: 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
时间窗: Baseline
Fractional shortening will be reported as a percentage (%)
Global longitudinal strain (GLS), echocardiographic parameter
时间窗: 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
时间窗: Baseline
TRpV is reported in m/s
Echocardiographic parameter, Indexed LV and RV stroke volumes
时间窗: 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
时间窗: 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
时间窗: 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'
时间窗: Baseline
The E/e' ratio is derived from the E wave velocity to the e' velocity
Levels of NT-proBNP
时间窗: Baseline
Levels of NT-proBNP from blood samples will be reported in ng/L
DISC1 mRNA quantification
时间窗: Baseline
Measured from blood samples and reported as fold change
Levels of high sensitive-CRP
时间窗: Baseline
Levels of HS-CRP mg/L
Levels of CK-MB
时间窗: Baseline
Levels of CK-MB is reported in µg/L
Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter
时间窗: 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
时间窗: baseline
TAPSE will be reported in millimeters (mm)
Echocardiographic parameters septal e' and lateral e' velocities
时间窗: Baseline
Septal e' and lateral e' velocities are reported as cm/s
Levels of Troponin I
时间窗: Baseline
Levels of Troponin I is reported in ng/L
Echocardiographic parameter MPI, Myocardial performance index
时间窗: 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
时间窗: Baseline
Mitral E/A ratio is derived from the ratio of the E wave velocity to the A wave velocity
Levels of IGF1
时间窗: Baseline
Levels of IGF1 from blood samples will be reported in nmol/L
Levels of BDNF, brain derived neurotrophic factor
时间窗: Baseline
Levels of BDNF from blood samples will be reported in ng/mL
Levels of Transforming Growth Factor Beta
时间窗: Baseline
Levels of Transforming Growth Factor Beta from blood samples will be reported in ng/mL
Interleukin levels
时间窗: Baseline
Interleukin levels from blood sample will be reported as pg/mL
Levels of Troponin T
时间窗: Baseline
Levels of Troponin T is reported in ng/L
Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline
peak E velocity is reported in cm/s
Echocardiography parameter of E wave deceleration time
时间窗: Baseline
E wave deceleration time is reported in milliseconds (ms)
Levels of Tumor Necrosis Factor alpha
时间窗: Baseline
Levels of Tumor Necrosis Factor alpha from blood samples will be reported in pg/mL
Echocardiographic parameter LAVI, left atrial volume indexed
时间窗: 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
时间窗: Baseline
S wave velocity is the peak systolic velocity of the tricuspid annulus and is reported in cm/s
Levels of ANP
时间窗: Baseline
Levels of ANP from blood samples will be reported in pg/mL
Levels of cardiac Myosin-Binding Protein C
时间窗: Baseline
Levels of cardiac Myosin-Binding Protein C from blood samples will be reported in ng/L
次要结局
- Number of participants with and abnormal ECG(Baseline)
- Incidence of cardiovascular disease or mortality as registered in a health registry on follow up(Within 15 years from start of study)
- Systolic Blood Pressure(Baseline)
- Potassium levels(Baseline)
- Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI(Baseline)
- LV Ejection Fraction, cardiac MRI(Baseline)
- Indexed LV mass, cardiac MRI(Baseline)
- Number of participants with abnormal liver function(Baseline)
- Number of participants with abnormal kidney function(Baseline)
- Number of participants with low Vitamin D levels(Baseline)
- ECG corrected QT interval(Baseline)
- Triglyceride levels(Baseline)
- native T1 time, cardiac MRI(Baseline)
- High-density lipoprotein, HDL-cholesterol levels(Baseline)
- Low-density lipoprotein, LDL-cholesterol levels(Baseline)
- Diastolic Blood Pressure(Baseline)
- Lipoprotein a(Baseline)
- Magnesium levels(Baseline)
- Calcium levels(Baseline)
- Sodium levels(Baseline)
- Heart rate measured on ECG(Baseline)
- Number of participants with abnormal thyroid function(Baseline)
- Fasting glucose levels(Baseline)
- Glycated Hemoglobin (HbA1c) levels(Baseline)
