Risk Prediction Model of Cardiovascular Events in Patients With Schizophrenia

NCT05498571 | Unknown

• 1 other identifier: 2020-YJ13
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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.

  2-10 years

Study Arms (1)

Schizophrenia Patients

We collect relevant information, review cardiovascular events in schizophrenia patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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".

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Shengke Pan, Master

  Shanghai Mental Health Center

  STUDY DIRECTOR

Central Study Contacts

Shengke Pan, Master

CONTACT

8618817314216; psk2012@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: August 12, 2022
• Study Start: December 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-04

Locations

CN (1)