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

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

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 Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Hypertension; Arrhythmias, Cardiac; Heart Valve Diseases; Brain Neoplasms; Myocarditis; Cardiomyopathies; Aortic Dissection; Structural Heart Disease; Heart Neoplasms; Ischemic Cerebrovascular Disease; Hemorrhagic Cerebrovascular Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 25000

Contacts and Locations

• Study Contact: Name: Gouliang Li; Phone Number: 13759982523; Email: liguoliang_med@163.com
• Study Contact Backup: Name: Yang Yan; Phone Number: 13259882601; Email: yangyan3@xjtu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xian Jiantong University
      • Contact: Guoliang Li; Email: liguoliang_med@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

12

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: General Hospital of Ningxia Medical University; Second Affiliated Hospital of Nanchang University; First Affiliated Hospital of Chongqing Medical University; Xi'an Gaoxin Hospital
• Investigators: Principal Investigator: Gouliang Li, First Affiliated Hospital Xi'an Jiaotong University; Principal Investigator: Yang Yan, First Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Prognosis; Cardiovascular diseases; Multi-omics; Cerebrovascular diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neoplasms by Site; Thoracic Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Coronary Disease; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Neoplasms; Coronary Artery Disease; Arrhythmias, Cardiac; Myocarditis; Brain Neoplasms; Cardiomyopathies; Heart Valve Diseases; Cerebrovascular Disorders; Heart Neoplasms; Aortic Dissection
• Other Study ID Numbers: XJTU1AF2023LSK-353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No