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

Hypertension Clinical Trial

— PROSPECT  

Official title:

Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics (PROSPECT): a National, Multicenter, Retrospective-prospective, Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06001073
• Other study ID #: XJTU1AF2023LSK-353
• Status: Not yet recruiting
• Start date: December 30, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Gouliang Li
• Phone: 13759982523
• Email: liguoliang_med[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25000
• Est. completion date: December 31, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 80 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Aortic Dissection
• Arrhythmias, Cardiac
• Brain Neoplasms
• Cardiomyopathies
• Cerebrovascular Disorders
• Coronary Artery Disease
• Heart Valve Diseases
• Hypertension
• Ischemic Cerebrovascular Disease
• Myocarditis
• Neoplasms
• Structural Heart Disease

Intervention

Other:
• Observational; No Interventions were given.
Observational; No Interventions were given.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi

Sponsors (5)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	First Affiliated Hospital of Chongqing Medical University, General Hospital of Ningxia Medical University, Second Affiliated Hospital of Nanchang University, Xi'an Gaoxin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of MACCE	Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke.	Through study completion, up to 5 years.
Secondary	Change of all-cause mortality	Incidence of patients' death from any cause.	Through study completion, up to 5 years.
Secondary	Incidence of myocardial infarction	Changes of serum myocardial zymogram level and ECG were used for diagnosing of myocardial infarction.	Through study completion, up to 5 years.
Secondary	Incidence of coronary revascularization.	Incidence of percutaneous coronary intervention or coronary artery bypass grafting.	Through study completion, up to 5 years.
Secondary	Incidence of stroke	Stroke were assessed by radiologist using CT scan or other imaging test.	Through study completion, up to 5 years.