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

NCT06001073 | Recruiting

• 1 other identifier: XJTU1AF2023LSK-353
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of all-cause mortality

  Through study completion, up to 5 years.

• Incidence of myocardial infarction

  Through study completion, up to 5 years.

• Incidence of coronary revascularization.

  Through study completion, up to 5 years.

• Incidence of stroke

  Through study completion, up to 5 years.

Study Arms (12)

Coronary artery disease group

Diagnosis of coronary artery disease by clinical guidelines.

Other: Observational; No Interventions were given.

Arrhythmia group

Diagnosis of arrhythmia by clinical guidelines. by clinical guidelines.

Other: Observational; No Interventions were given.

Heart valve disease group

Diagnosis of heart valve disease by clinical guidelines.

Other: Observational; No Interventions were given.

aortic dissection group

Diagnosis of aortic dissection by clinical guidelines.

Other: Observational; No Interventions were given.

Cardiac masses group

Diagnosis of cardiac messes by clinical guidelines.

Other: Observational; No Interventions were given.

Myocarditis group

Diagnosis of myocarditis by clinical guidelines.

Other: Observational; No Interventions were given.

Hypertension group

Diagnosis of hypertension by clinical guidelines.

Other: Observational; No Interventions were given.

Cardiomyopathy group

Diagnosis of cardiomyopathy by clinical guidelines.

Other: Observational; No Interventions were given.

Structural heart disease group

Diagnosis of structural heart disease by clinical guidelines.

Other: Observational; No Interventions were given.

Ischemic cerebrovascular disease group

Diagnosis of ischemic cerebrovascular disease by clinical guidelines.

Other: Observational; No Interventions were given.

Hemorrhagic cerebrovascular disease group

Diagnosis of hemorrhagic cerebrovascular disease by clinical guidelines.

Other: Observational; No Interventions were given.

Intracranial space occupying lesion group

Diagnosis of intracranial space occupying by clinical guidelines.

Other: Observational; No Interventions were given.

Interventions

Observational; No Interventions were given. OTHER

Observational; No Interventions were given.

Arrhythmia group; Cardiac masses group; Cardiomyopathy group; Coronary artery disease group; Heart valve disease group; Hemorrhagic cerebrovascular disease group; Hypertension group; Intracranial space occupying lesion group; Ischemic cerebrovascular disease group; Myocarditis group; Structural heart disease group; aortic dissection group

Eligibility Criteria

• Age: 3 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, feces urine and tissues.

MeSH Terms

Conditions

Coronary Artery Disease; Arrhythmias, Cardiac; Heart Valve Diseases; Aortic Dissection; Heart Neoplasms; Myocarditis; Hypertension; Cardiomyopathies; Brain Neoplasms; Cardiovascular Diseases; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dissection, Blood Vessel; Aneurysm; Acute Aortic Syndrome; Aortic Diseases; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Gouliang Li

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Yang Yan

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gouliang Li

CONTACT

13759982523; liguoliang_med@163.com

Yang Yan

CONTACT

13259882601; yangyan3@xjtu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: December 5, 2022
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)