Fujian Province Cardiovascular Diseases Study

NCT ID: NCT02430025

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 8000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2020-05-31

Brief Summary

This proposal delineates a research plan to collect blood from the patients with cardiovascular diseases for the purpose of establishing a molecular biological bank registry. The Fujian provincial hospital will enroll 8,000 patients.The blood collected will be processed to create a repository of molecular biological plasma. Along with a sample of blood collected from individual patients, a concise general medical history, demographic data, electrocardiographic data, echocardiographic data, and laboratory data will be collected. A short interview will take place after enrollment during the outpatient visit or hospital stay, or may be conducted via phone call after enrollment. All the clinical data gathered will be compiled in Fujian provincial hospital center database, and would be stored in a format where a culmination of clinical findings, i.e. representing a disease of interest, can be used to search the database to identify the blood samples of all patients with such characteristics for further study.

Detailed Description

The study is to commence on May 1st 2015 and is to be completed within 3-5 years. The targeted number of patients to be enrolled is 8,000. All patients have the history of cardiovascular diseases, will be eligible to be enrolled. Patients inclusion criteria are as follows, once informed consent is obtained:

1. Males or females at least 18 years old.

2. Patient has not been previously enrolled in the molecular biological bank registry of the Fujian provincial hospital.

3. Patient able to give informed consent.

4. Any patient with history of cardiovascular diseases (If a subject reports history of cardiovascular diseases at another facility, outside records will be obtained to confirm the diagnosis.

Conditions

Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

control subjects

people had no clinical history of cardiovascular diseases,no family history of premature cardiovascular diseases.

No interventions assigned to this group

coronary atherosclerosis

Subjects with CAD also had at least one \<50% stenotic lesion on coronary angiography.

No interventions assigned to this group

stable coronary artery disease

Subjects with stable CAD had clinically established atherosclerotic vascular disease but had been stable for ≥3 months.

No interventions assigned to this group

acute coronary syndrome

Subjects with CAD also had at least one ≥50% stenotic lesion on coronary angiography or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting. All subjects with ACS exhibited acute ECG changes consistent with myocardial ischemia or elevated troponin levels. ACS was confirmed with urgent coronary angiography; all subjects had at least one ≥50% stenotic lesion with ruptured plaque or thrombus.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 18-80 year old males and non-child-bearing period females.
• Clinical diagnosed with acute coronary syndrome including NSTE-ACS ,MI and STEMI.
• Patients with STEMI((ST segment elevation myocardial infarction) and NSTEMI(non-ST segment elevation myocardial infarction) will be recruited within 48 hours of symptom onset.
• Patients with cerebrovascular disease was made or confirmed by a board-certified neurologist with fellowship training in cerebrovascular disease and confirmed by standard diagnostic techniques such as head CT, MRI, MR angiography, CT angiography, carotid ultrasound, etc.
• Sign the ICF(inform consent form)

Exclusion Criteria

• child-bearing women
• hypothyroidism,
• active liver disease or dysfunction including agnogenic serum transaminase sustained elevation or higher than 3 times ULN(upper limit of normal)
• severe anemia (hemoglobin,hematocrit < 28%)
• A history of psychiatric disorders
• A history of jejunoileal bypass or gastric bypass surgery
• Currently take steroids therapy
• Diagnosed with malignant within 5 years
• Severe renal function damage (creatinine clearance rate<30 ml/min)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University

OTHER

Sponsor Role: collaborator

Fujian Provincial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guo Yansong

Director of the cardiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yan so Guo, doctorate

Role: STUDY_DIRECTOR

Fujian Provincial Hospital

Central Contacts

yan so Guo, doctorate

Role: CONTACT

ysguo1234@hotmail.com

+8613509384950

xin ji Chen, doctorate

Role: CONTACT

3319326@163.com

+8613405927173

References

Chen X, Guo Y, Lai L, Zhang S, Li Z. Intracoronary and peripheral blood levels of TNF-like Cytokine 1A (TL1A) in patients with acute coronary syndrome. Medicine (Baltimore). 2020 May 29;99(22):e20305. doi: 10.1097/MD.0000000000020305.

Reference Type: DERIVED

PMID: 32481400 (View on PubMed)

Other Identifiers

FJPH20150101

Identifier Type: -

Identifier Source: org_study_id