Clinical trial NCT06001073: Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics
Official title: Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics (PROSPECT): a National, Multicenter, Retrospective-prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: Cardiovascular diseases
Cerebrovascular diseases
Prognosis
Multi-omics
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Xi'an Gaoxin Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: General Hospital of Ningxia Medical University
name: Second Affiliated Hospital of Nanchang University
First posted: 2023-08-21
Enrollment: 25000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cardiovascular and cerebrovascular diseases will be recruited, including coronary artery disease, arrhythmia, heart valve disease, aortic dissection, cardiac masses, myocarditis, hypertension, cardiomyopathy, structural heart disease, ischemic cerebrovascular disease, hemorrhagic cerebrovascular disease, and intracranial space occupying lesion.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of MACCE
timeFrame: Through study completion, up to 5 years.
Secondary outcomes:
measure: Change of all-cause mortality
timeFrame: Through study completion, up to 5 years.
measure: Incidence of myocardial infarction
timeFrame: Through study completion, up to 5 years.
measure: Incidence of coronary revascularization.
timeFrame: Through study completion, up to 5 years.
measure: Incidence of stroke
timeFrame: Through study completion, up to 5 years.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Gouliang Li
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
References: