跳至主要内容
临床试验/NCT06304233
NCT06304233进行中(未招募)不适用

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

Norwegian University of Science and Technology2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年12月13日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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