Fujian Province Cardiovascular Diseases Study
FJCVD
1 other identifier
observational
8,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedApril 29, 2015
April 1, 2015
4.9 years
April 23, 2015
April 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To further find some unknown small Metabolic molecules by mass spectrometry
3-5 years
Study Arms (4)
control subjects
people had no clinical history of cardiovascular diseases,no family history of premature cardiovascular diseases.
coronary atherosclerosis
Subjects with CAD also had at least one \<50% stenotic lesion on coronary angiography.
stable coronary artery disease
Subjects with stable CAD had clinically established atherosclerotic vascular disease but had been stable for ≥3 months.
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.
Eligibility Criteria
The control subjects had no clinical history of cardiovascular diseases, no family history of premature cardiovascular diseases.Subjects had all arteries\<50% stenotic lesion on cardiocerebral vascular angiography. Subjects with stable CAD had clinically established atherosclerotic vascular disease but had been stable for ≥3 months. 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. ACS was confirmed with urgent coronary angiography; all subjects had at least one ≥50% stenotic lesion with ruptured plaque or thrombus.
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fujian Provincial Hospitallead
- Peking Universitycollaborator
Related Publications (1)
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.
PMID: 32481400DERIVED
Biospecimen
Approximately 30 mls of blood will be dispensed as follows : 3 x 10 mls EDTA Tube (Blood was collected from overnight-fasted subjects into ice-cold tubes containing EDTA) (6 mmol/L final concentration).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
yan so Guo, doctorate
Fujian Provincial Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the cardiology department
Study Record Dates
First Submitted
April 23, 2015
First Posted
April 29, 2015
Study Start
June 1, 2015
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
April 29, 2015
Record last verified: 2015-04