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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06001073

Collaborator

Xi'an Gaoxin Hospital (Other), First Affiliated Hospital of Chongqing Medical University (Other), General Hospital of Ningxia Medical University (Other), Second Affiliated Hospital of Nanchang University (Other)

25,000

Enrollment

Location

62.1

Anticipated Duration (Months)

402.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Arrhythmias, Cardiac Heart Valve Diseases Aortic Dissection Heart Neoplasms Myocarditis Hypertension Cardiomyopathies Structural Heart Disease Ischemic Cerebrovascular Disease Hemorrhagic Cerebrovascular Disease Brain Neoplasms	Other: Observational; No Interventions were given.

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 Design

Study Type:

Observational

Anticipated Enrollment :

25000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 30, 2023

Anticipated Primary Completion Date :

Jun 30, 2028

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Change of all-cause mortality [Through study completion, up to 5 years.]
Incidence of patients' death from any cause.
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.
Incidence of coronary revascularization. [Through study completion, up to 5 years.]
Incidence of percutaneous coronary intervention or coronary artery bypass grafting.
Incidence of stroke [Through study completion, up to 5 years.]
Stroke were assessed by radiologist using CT scan or other imaging test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi	China	710061

Sponsors and Collaborators

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

Investigators

Principal Investigator: Gouliang Li, First Affiliated Hospital Xi'an Jiaotong University
Principal Investigator: Yang Yan, First Affiliated Hospital of Xian Jiaotong University