Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics

Recruiting

• Conditions: Coronary Artery Disease; Heart Valve Diseases; Myocarditis; Cardiomyopathies; Hemorrhagic Cerebrovascular Disease; Aortic Dissection; Hypertension; Arrhythmias, Cardiac; Brain Neoplasms; Heart Neoplasms
• Interventions: Other: Observational; No Interventions were given.

• Registration Number: NCT06001073
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research topics in the study of cardiovascular and cerebrovascular diseases. This study intends to collect clinical data and biological specimen data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and exclusion criteria, and use multi-omics technology to deeply understand the pathogenic mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to construct early predictive prognostic models and provide a basis for effective treatment of clinical practice in patients with cardiovascular and cerebrovascular diseases.

Detailed Description

Cardiovascular and cerebrovascular diseases refer to ischemic and hemorrhagic diseases of the heart, brain and body tissues caused by hyperlipidemia, blood viscosity, atherosclerosis, hypertension, etc. It is one of the major public health problems in the world. The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research topics in the study of cardiovascular and cerebrovascular diseases. This study intends to collect clinical data and biological specimen data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and exclusion criteria, and use multi-omics technology to deeply understand the pathogenic mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to construct early predictive prognostic models and provide a basis for effective treatment of clinical practice in patients with cardiovascular and cerebrovascular diseases.

Study Timeline

• Study Start: 2022-12-05
• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2028-06-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

• Patients who are regularly visited and followed up in the appropriate patient; department.
• All patients met at least one of the following diagnostic criteria for cardiovascular and cerebrovascular diseases:
• coronary artery disease group;
• arrhythmia group;
• heart valve disease group;
• aortic dissection group;
• cardiac masses group;
• myocarditis group;
• hypertension group;
• cardiomyopathy group;
• structural heart disease group;
• ischemic cerebrovascular disease group;
• hemorrhagic cerebrovascular disease group;
• intracranial space occupying lesion group.

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Exclusion Criteria

• Age <3 years or >80 years old;
• Pregnant and lactating women;
• The patient declined to provide informed consent to participate in the study;
• None of the above was met, but the patient was temporarily unable to sign the informed consent form due to coma and other reasons, and no legal representative signed it instead. Depending on the patient's condition, the patient may not be able to regain consciousness and sign the informed consent form.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypertension group	Observational; No Interventions were given.	Diagnosis of hypertension by clinical guidelines.
Structural heart disease group	Observational; No Interventions were given.	Diagnosis of structural heart disease by clinical guidelines.
Coronary artery disease group	Observational; No Interventions were given.	Diagnosis of coronary artery disease by clinical guidelines.
Cardiac masses group	Observational; No Interventions were given.	Diagnosis of cardiac messes by clinical guidelines.
Cardiomyopathy group	Observational; No Interventions were given.	Diagnosis of cardiomyopathy by clinical guidelines.
Intracranial space occupying lesion group	Observational; No Interventions were given.	Diagnosis of intracranial space occupying by clinical guidelines.
Myocarditis group	Observational; No Interventions were given.	Diagnosis of myocarditis by clinical guidelines.
Arrhythmia group	Observational; No Interventions were given.	Diagnosis of arrhythmia by clinical guidelines. by clinical guidelines.
aortic dissection group	Observational; No Interventions were given.	Diagnosis of aortic dissection by clinical guidelines.
Ischemic cerebrovascular disease group	Observational; No Interventions were given.	Diagnosis of ischemic cerebrovascular disease by clinical guidelines.
Heart valve disease group	Observational; No Interventions were given.	Diagnosis of heart valve disease by clinical guidelines.
Hemorrhagic cerebrovascular disease group	Observational; No Interventions were given.	Diagnosis of hemorrhagic cerebrovascular disease by clinical guidelines.

Primary Outcome Measures

Name	Time	Method
Change of MACCE	Through study completion, up to 5 years.	Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke.

Secondary Outcome Measures

Name	Time	Method
Incidence of myocardial infarction	Through study completion, up to 5 years.	Changes of serum myocardial zymogram level and ECG were used for diagnosing of myocardial infarction.
Change of all-cause mortality	Through study completion, up to 5 years.	Incidence of patients' death from any cause.
Incidence of stroke	Through study completion, up to 5 years.	Stroke were assessed by radiologist using CT scan or other imaging test.
Incidence of coronary revascularization.	Through study completion, up to 5 years.	Incidence of percutaneous coronary intervention or coronary artery bypass grafting.

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiantong University; 🇨🇳 Xi'an, Shaanxi, China