Fujian Province Cardiovascular Diseases Study

Cardiovascular Diseases Clinical Trial

— FJCVD  

Official title:

Fujian Province Cardiovascular Diseases Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02430025
• Other study ID #: FJPH20150101
• Status: Not yet recruiting
• Phase: N/A
• First received: April 23, 2015
• Last updated: April 28, 2015
• Start date: June 2015
• Est. completion date: May 2020

Study information

• Verified date: April 2015
• Source: Fujian Provincial Hospital
• Contact: yan so Guo, doctorate
• Phone: +8613509384950
• Email: ysguo1234[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Fujian Province
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8000
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fujian Provincial Hospital	Peking University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To further find some unknown small Metabolic molecules by mass spectrometry		3-5 years	No