Clinical trial NCT06304233: The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Diseases
Heart; Functional Disturbance
Schizophrenia
Keywords: Disrupted in Schizophrenia 1
DISC1
Cardiac Biomarker
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2024-03-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort with schizophrenia will be recruited from outpatient and inpatient population from a single centre.

The cohort without mental health diagnosis will be selected from an existing population registered in the HUNT data and biobank and be matched for age (± 2 years) and sex of the patients.

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with ICD-10 schizophrenia, schizotypal or delusional disorders (F20 to F29)
* Both inpatient and outpatient
* Capable of giving informed consent

Exclusion Criteria:

* Current or previous diagnosis of cancer
* Current or previous treatment with chemotherapy
* Current pregnancy
* Mothers less than 6 months post-partum

Primary outcomes:
measure: Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography
timeFrame: Baseline
measure: Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography
timeFrame: Baseline
measure: DISC1 mRNA quantification
timeFrame: Baseline
measure: Levels of high sensitive-CRP
timeFrame: Baseline
measure: Levels of CK-MB
timeFrame: Baseline
measure: Levels of Troponin T
timeFrame: Baseline
measure: Levels of Troponin I
timeFrame: Baseline
measure: Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter
timeFrame: Baseline
measure: Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter
timeFrame: Baseline
measure: Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter
timeFrame: Baseline
measure: Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter
timeFrame: Baseline
measure: Left ventricular mass measured by echocardiography
timeFrame: Baseline
measure: Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography
timeFrame: Baseline
measure: Fractional shortening measured by echocardiography
timeFrame: Baseline
measure: Global longitudinal strain (GLS), echocardiographic parameter
timeFrame: Baseline
measure: TAPSE echocardiographic parameter of right ventricular longitudinal systolic function
timeFrame: baseline
measure: Echocardiographic parameter MPI, Myocardial performance index
timeFrame: Baseline
measure: Echocardiographic parameter Mitral E/A ratio
timeFrame: Baseline
measure: Echocardiography parameter of peak E velocity
timeFrame: Baseline
measure: Echocardiography parameter of E wave deceleration time
timeFrame: Baseline
measure: Echocardiography parameter of ratio of E/e'
timeFrame: Baseline
measure: Echocardiographic parameters septal e' and lateral e' velocities
timeFrame: Baseline
measure: Echocardiographic parameter LAVI, left atrial volume indexed
timeFrame: Baseline
measure: Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity
timeFrame: Baseline
measure: Echocardiographic parameter, S wave velocity
timeFrame: Baseline
measure: Echocardiographic parameter, Indexed LV and RV stroke volumes
timeFrame: Baseline
measure: Levels of NT-proBNP
timeFrame: Baseline
measure: Levels of IGF1
timeFrame: Baseline
measure: Levels of ANP
timeFrame: Baseline
measure: Levels of BDNF, brain derived neurotrophic factor
timeFrame: Baseline
measure: Levels of Tumor Necrosis Factor alpha
timeFrame: Baseline
measure: Levels of Transforming Growth Factor Beta
timeFrame: Baseline
measure: Levels of cardiac Myosin-Binding Protein C
timeFrame: Baseline
measure: Interleukin levels
timeFrame: Baseline
Secondary outcomes:
measure: native T1 time, cardiac MRI
timeFrame: Baseline
measure: Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI
timeFrame: Baseline
measure: Indexed LV mass, cardiac MRI
timeFrame: Baseline
measure: LV Ejection Fraction, cardiac MRI
timeFrame: Baseline
measure: ECG corrected QT interval
timeFrame: Baseline
measure: Number of participants with and abnormal ECG
timeFrame: Baseline
measure: Number of participants with abnormal liver function
timeFrame: Baseline
measure: Number of participants with abnormal kidney function
timeFrame: Baseline
measure: Number of participants with abnormal thyroid function
timeFrame: Baseline
measure: Number of participants with low Vitamin D levels
timeFrame: Baseline
measure: Incidence of cardiovascular disease or mortality as registered in a health registry on follow up
timeFrame: Within 15 years from start of study
measure: Triglyceride levels
timeFrame: Baseline
measure: High-density lipoprotein, HDL-cholesterol levels
timeFrame: Baseline
measure: Low-density lipoprotein, LDL-cholesterol levels
timeFrame: Baseline
measure: Fasting glucose levels
timeFrame: Baseline
measure: Glycated Hemoglobin (HbA1c) levels
timeFrame: Baseline
measure: Heart rate measured on ECG
timeFrame: Baseline
measure: Systolic Blood Pressure
timeFrame: Baseline
measure: Diastolic Blood Pressure
timeFrame: Baseline
measure: Lipoprotein a
timeFrame: Baseline
measure: Magnesium levels
timeFrame: Baseline
measure: Calcium levels
timeFrame: Baseline
measure: Sodium levels
timeFrame: Baseline
measure: Potassium levels
timeFrame: Baseline
Other outcomes:
measure: Alcohol intake at baseline using The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaire
timeFrame: Baseline
measure: Average length of inpatient stay for schizophrenia related admissions
timeFrame: Baseline
measure: Need of Care based on number of total hospital admission for schizophrenia
timeFrame: Baseline
measure: Severity scoring of psychiatric symptoms using Clinical Global Impressions (CGI) Scale - Severity
timeFrame: Baseline
measure: Schizophrenia symptom severity as scored on the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline
measure: Duration of schizophrenia
timeFrame: Baseline
measure: Length of treatment with an antipsychotic medication
timeFrame: Baseline
measure: Antipsychotic dosage in daily equivalent dosage of chlorpromazine
timeFrame: Baseline
measure: Smoking status
timeFrame: Baseline
measure: Waist Hip Ratio
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: Body fat percent
timeFrame: Baseline
measure: Physical Activity
timeFrame: Baseline
measure: Body muscle composition
timeFrame: Baseline
measure: Smoking history
timeFrame: Baseline
measure: Age of participant
timeFrame: Baseline
measure: Gender of participant
timeFrame: Baseline
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
city: Trondheim
country: Norway
facility: St Olavs Hospital, Trondheim University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Morten A Høydal, PhD
role: STUDY_DIRECTOR
References: