- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02430025
Fujian Province Cardiovascular Diseases Study (FJCVD)
April 28, 2015 updated by: Guo Yansong, Fujian Provincial Hospital
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.
Study Overview
Status
Unknown
Conditions
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:
- Males or females at least 18 years old.
- Patient has not been previously enrolled in the molecular biological bank registry of the Fujian provincial hospital.
- Patient able to give informed consent.
- 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.
Study Type
Observational
Enrollment (Anticipated)
8000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: yan so Guo, doctorate
- Phone Number: +8613509384950
- Email: ysguo1234@hotmail.com
Study Contact Backup
- Name: xin ji Chen, doctorate
- Phone Number: +8613405927173
- Email: 3319326@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To further find some unknown small Metabolic molecules by mass spectrometry
Time Frame: 3-5 years
|
3-5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: yan so Guo, doctorate, Fujian Provincial Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (ANTICIPATED)
May 1, 2020
Study Completion (ANTICIPATED)
May 1, 2020
Study Registration Dates
First Submitted
April 23, 2015
First Submitted That Met QC Criteria
April 28, 2015
First Posted (ESTIMATE)
April 29, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
April 29, 2015
Last Update Submitted That Met QC Criteria
April 28, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FJPH20150101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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