The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease

NCT ID: NCT06304233

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-13

Study Completion Date

2038-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Diseases Heart; Functional Disturbance Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diagnosed with Schizophrenia

Patients with a ICD-10 diagnosis of Schizophrenia will undergo investigations to assess cardiac function, cardiovascular disease risk factors and DISC1 mRNA expression. Participants eligible for MRI will be invited to undergo cardiac MRI in addition to echocardiography.

Echocardiography

Intervention Type DIAGNOSTIC_TEST

ultrasound assessment of heart structure, volume and function

Cardiac Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

MRI assessment of heart structure, volume, function and tissue characteristics

Electrocardiography

Intervention Type DIAGNOSTIC_TEST

Assessment of cardiac rhythm and electrical activity

Blood sampling

Intervention Type OTHER

To measure DISC1 mRNA expression and other potential biomarkers

No mental health diagnosis

Participants without a mental health diagnosis will be randomly selected from an existing population registered in the HUNT data and biobank for whom, echocardiographic data and biological samples are available.Those enrolled as controls will be invited to participate in the cardiac MRI portion of the study.

Echocardiography

Intervention Type DIAGNOSTIC_TEST

ultrasound assessment of heart structure, volume and function

Cardiac Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

MRI assessment of heart structure, volume, function and tissue characteristics

Electrocardiography

Intervention Type DIAGNOSTIC_TEST

Assessment of cardiac rhythm and electrical activity

Blood sampling

Intervention Type OTHER

To measure DISC1 mRNA expression and other potential biomarkers

Interventions

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Echocardiography

ultrasound assessment of heart structure, volume and function

Intervention Type DIAGNOSTIC_TEST

Cardiac Magnetic Resonance Imaging

MRI assessment of heart structure, volume, function and tissue characteristics

Intervention Type DIAGNOSTIC_TEST

Electrocardiography

Assessment of cardiac rhythm and electrical activity

Intervention Type DIAGNOSTIC_TEST

Blood sampling

To measure DISC1 mRNA expression and other potential biomarkers

Intervention Type OTHER

Other Intervention Names

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Echo Cardiac MRI CMRI Holter ECG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morten A Høydal, PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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Norwegian University of Science and Technology

Trondheim, , Norway

Site Status

St Olavs Hospital, Trondheim University Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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606103

Identifier Type: -

Identifier Source: org_study_id

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