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RecruitingNCT06001073PROSPECTUpdated Jul 12, 2024

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

An observational study in Coronary Artery Disease, Arrhythmias, Cardiac and Heart Valve Diseases, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 3 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
25,000
Ages
3 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
3 Years to 80 Years
Sexes eligible
All
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
25,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherObservational; No Interventions were given.

    Observational; No Interventions were given.

05

What researchers measure

Primary outcomes

  1. Change of MACCE

    Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke.

    Time frame: Through study completion, up to 5 years.

Secondary outcomes

  1. Change of all-cause mortality

    Incidence of patients' death from any cause.

    Time frame: Through study completion, up to 5 years.

  2. Incidence of myocardial infarction

    Changes of serum myocardial zymogram level and ECG were used for diagnosing of myocardial infarction.

    Time frame: Through study completion, up to 5 years.

  3. Incidence of coronary revascularization.

    Incidence of percutaneous coronary intervention or coronary artery bypass grafting.

    Time frame: Through study completion, up to 5 years.

  4. Incidence of stroke

    Stroke were assessed by radiologist using CT scan or other imaging test.

    Time frame: Through study completion, up to 5 years.

06

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Xian Jiantong University
    Xi'an, Shaanxi 710061, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06001073
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Xi'an Gaoxin Hospital, First Affiliated Hospital of Chongqing Medical University, General Hospital of Ningxia Medical University, Second Affiliated Hospital of Nanchang University
Responsible party
Sponsor
First posted
Aug 21, 2023
Start date
Dec 5, 2022
Primary completion
Jun 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jul 12, 2024

Study contacts

Gouliang Li
Contact
liguoliang_med@163.com
13759982523
Yang Yan
Contact
yangyan3@xjtu.edu.cn
13259882601
Gouliang Li
principal investigator · First Affiliated Hospital Xi'an Jiaotong University
Yang Yan
principal investigator · First Affiliated Hospital of Xian Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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