Cardiovascular DiseasesFJCVDNCT02430025
Fujian Province Cardiovascular Diseases Study
An observational study of Cardiovascular Diseases, run by Fujian Provincial Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 8,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
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- Currently take steroids therapy
- Diagnosed with malignant within 5 years
- Severe renal function damage (creatinine clearance rate<30 ml/min)
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, Vascular Diseases, Acute Coronary Syndrome, Chest Pain, Heart Diseases, Myocardial Ischemia, Pathologic Processes
- Medical subject headings
- Cardiovascular Diseases, Vascular Diseases, Acute Coronary Syndrome, Chest Pain, Heart Diseases, Myocardial Ischemia, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To further find some unknown small Metabolic molecules by mass spectrometry
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Principal investigator, Guo Yansong, Fujian Provincial Hospital
- Investigators
- yan so Guo, doctorate, Study director, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430025
- Sponsor's protocol ID
- FJPH20150101
- Acronym
- FJCVD
- Status last verified
- Apr 2015
- First submitted
- 23 Apr 2015
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32481400
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fujian Province Cardiovascular Diseases Study
- ClinicalTrials.gov ID
- NCT02430025
- Acronym / sponsor ID
- FJCVD / FJPH20150101
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, Vascular Diseases, Acute Coronary Syndrome, Chest Pain, Heart Diseases, Myocardial Ischemia, Pathologic Processes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- Jun 2015
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To further find some unknown small Metabolic molecules by mass spectrometry
Time frame: 3-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Derived from this study: PubMed 32481400Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yan so Guo, doctorate study director
Fujian Provincial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Fujian Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yan so Guo, doctorate (+8613509384950, ysguo1234@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To further find some unknown small Metabolic molecules by mass spectrometry (time frame: 3-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02430025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.