SchizophreniaNCT05498571
Risk Prediction Model of Cardiovascular Events in Patients With Schizophrenia
An observational study of Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Schizophrenia is a serious mental illness that has a great impact on social function. Studies have evidenced that schizophrenia patients live 10-20 years less than general population.It mainly dues to high cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized before July 1, 2020；and hospitalized between July 1 2020-June 30, 2022.The patients' diagnoses meet ICD-10 diagnostic criteria for "schizophrenia, schizophrenia, delusional disorder" or ICD-11 for "schizophrenia and other primary mental disorders".
Who may be able to join
- Patients hospitalized before July 1, 2020；and hospitalized between July 1 2020-June 30, 2022；
- Meeting the ICD-10 diagnostic criteria for "Schizophrenia, Schizotypy, delusional disorder"or ICD-11 diagnostic criteria for "Schizophrenia and other Primary Mental Disorders";
- At least 2 doctors in charge of ward make definitive diagnoses;
- Age ≥18 years old, male and female are not limited.
Who cannot join
- Researchers consider patients unsuitable for the study;
- past history of cardiovascular disease (fatal and nonfatal cardiovascular events defined as myocardial infarction, Angina, coronary heart disease, coronary artery surgery, cerebrovascular accident and transient ischemic attack, peripheral arterial disease or revascularization) prior to antipsychotic therapy ;
- use of lipid lowering drugs or antiplatelet drugs, such as aspirin、statins ，prior to antipsychotic therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Shengke Pan, Master, 8618817314216, psk2012@126.com
About this study
Schizophrenia is a serious mental illness that has a great impact on social function. Studies have evidenced that schizophrenia patients live 10-20 years less than general population.It mainly dues to high cardiovascular risk. How to improve patients' survival rates? At present, there is an objective model to assess cardiovascular risk among schizoprenia patients in England - PRIMROSE.But there is a lack of model for schizophrenia patients in china. In order to better guide clinical practice, we are now exploring a domestic cardiovascular risk prediction model to raise people's awareness.
Read the detailed description
Schizophrenia is a common severe mental disorder with high rate of disability, which seriously affects patients' life.It is necessary to take long-term therapy to control symptoms or prevent recurrence. Studies have found that schizophrenia patients live on average ten to twenty-five years less than others. The main reason for high rates of mortality and disability is the high risk of cardiovascular events.There are few domestic large-scale studys on the risk of cardiovascular events in schizophrenia, thus they have not formed objective tools to assess cardiovascular risk. If this risk can be objectively assessed and predicted at an early stage, it is expected to reduce the risk of cardiovascular events and thus reduce mortality.At present, there are mature tools for assessing the risk of cardiovascular events in patients, such as Framingham, PRIMROSE, etc.The latter is the new tool for assessing cardiovascular events in patients with severe mental disorders. This study used a retrospective cohort design to collect the history of hospitalized schizophrenia patients within 2 years, collect relevant informations about cardiovascular events. The investigators validate the PRIMROSE model in China and explore the risk prediction model of cardiovascular events in schizophrenia patients.
- Conditions
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia Patients | We collect relevant information, review cardiovascular events in schizophrenia patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular events
Cardiovascular events end points were defined as the first occurrence of fatal or non-fatal cardiovascular events.They were collected and individually validated using data from the clinical diagnosis items, including data from emergency room visits, cardiology consultations, and tests (MRI,CT,ECG,Troponin I,Troponin T,coronary angiography etc). Fatal and non-fatal cardiovascular events are defined as myocardial infarction, Angina, coronary heart disease, coronary artery surgery, cerebrovascular accident and transient ischemic attack, peripheral artery disease or revascularization;cardiovascular and all-cause mortality.We need to record the time of the first cardiovascular events and diagnosis items.
Measured: 2-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shengke Pan, Master, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498571
- Sponsor's protocol ID
- 2020-YJ13
- Status last verified
- Apr 2022
- First submitted
- 21 Nov 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Prediction Model of Cardiovascular Events in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT05498571
- Acronym / sponsor ID
- 2020-YJ13
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schizophrenia is a serious mental illness that has a great impact on social function. Studies have evidenced that schizophrenia patients live 10-20 years less than general population.It mainly dues to high cardiovascular risk. How to improve patients' survival rates? At present, there is an objective model to assess cardiovascular risk among schizoprenia patients in England - PRIMROSE.But there is a lack of model for schizophrenia patients in china. In order to better guide clinical practice, we are now exploring a domestic cardiovascular risk prediction model to raise people's awareness.
Detailed description
Schizophrenia is a common severe mental disorder with high rate of disability, which seriously affects patients' life.It is necessary to take long-term therapy to control symptoms or prevent recurrence. Studies have found that schizophrenia patients live on average ten to twenty-five years less than others. The main reason for high rates of mortality and disability is the high risk of cardiovascular events.There are few domestic large-scale studys on the risk of cardiovascular events in schizophrenia, thus they have not formed objective tools to assess cardiovascular risk. If this risk can be objectively assessed and predicted at an early stage, it is expected to reduce the risk of cardiovascular events and thus reduce mortality.At present, there are mature tools for assessing the risk of cardiovascular events in patients, such as Framingham, PRIMROSE, etc.The latter is the new tool for assessing cardiovascular events in patients with severe mental disorders. This study used a retrospective cohort design to collect the history of hospitalized schizophrenia patients within 2 years, collect relevant informations about cardiovascular events. The investigators validate the PRIMROSE model in China and explore the risk prediction model of cardiovascular events in schizophrenia patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia Patients | – | –We collect relevant information, review cardiovascular events in schizophrenia patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized before July 1, 2020；and hospitalized between July 1 2020-June 30, 2022.The patients' diagnoses meet ICD-10 diagnostic criteria for "schizophrenia, schizophrenia, delusional disorder" or ICD-11 for "schizophrenia and other primary mental disorders".
Key inclusion criteria (4 listed)
- Patients hospitalized before July 1, 2020；and hospitalized between July 1 2020-June 30, 2022；
- Meeting the ICD-10 diagnostic criteria for "Schizophrenia, Schizotypy, delusional disorder"or ICD-11 diagnostic criteria for "Schizophrenia and other Primary Mental Disorders";
- At least 2 doctors in charge of ward make definitive diagnoses;
- Age ≥18 years old, male and female are not limited.
Key exclusion criteria (3 listed)
- Researchers consider patients unsuitable for the study;
- past history of cardiovascular disease (fatal and nonfatal cardiovascular events defined as myocardial infarction, Angina, coronary heart disease, coronary artery surgery, cerebrovascular accident and transient ischemic attack, peripheral arterial disease or revascularization) prior to antipsychotic therapy ;
- use of lipid lowering drugs or antiplatelet drugs, such as aspirin、statins ，prior to antipsychotic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiovascular events
Time frame: 2-10 years
Cardiovascular events end points were defined as the first occurrence of fatal or non-fatal cardiovascular events.They were collected and individually validated using data from the clinical diagnosis items, including data from emergency room visits, cardiology consultations, and tests (MRI,CT,ECG,Troponin I,Troponin T,coronary angiography etc). Fatal and non-fatal cardiovascular events are defined as myocardial infarction, Angina, coronary heart disease, coronary artery surgery, cerebrovascular accident and transient ischemic attack, peripheral artery disease or revascularization;cardiovascular and all-cause mortality.We need to record the time of the first cardiovascular events and diagnosis items.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengke Pan, Master study director
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengke Pan, Master (8618817314216, psk2012@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular events (time frame: 2-10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.