The Association Between Very Small Embryonic-like Stem Cells and the Prognosis of Coronary Artery Disease Patients
NCT ID: NCT01633359
Last Updated: 2012-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
300 participants
INTERVENTIONAL
2012-07-31
2013-05-31
Brief Summary
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Detailed Description
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2. The number and function of peripheral blood VSELs in CAD patients compared with the controls.
1. Included patients: including 200 CAD patients receiving coronary angiography (CAG) as positive subjects, 100 as control who are negative for CAG.
2. The IRB approve and all subjects sign the informed consent.
3. All subjects will receive the detection and analysis of the peripheral blood VSELs, including VSEL number, immigration capability after sCD40L administration.
4. All subjects will receive the follow-up for 1 year, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
5. the association between VSELs and MACE in CAD patients will be statistically analyzed.
3. Atorvastatin administration improves the prognosis of CAD patients through exerting impacts on VSELs
1. Included patients: including 200 CAD patients receiving coronary angiography as positive subjects, 100 as control who are negative for coronary angiography.
2. The IRB approve and all subjects sign the informed consent.
3. Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls.
4. All subject will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
5. the Intensive Atorvastatin protocol indicates that 80mg Atorvastatin will be administrated before CAG, and then are followed with 20mg Atorvastatin during the entire study period.
6. the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intensive statin
1. Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls.
2. All subjects will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
3. the Intensive Atorvastatin protocol indicates that 80mg Atorvastatin will be administrated before CAG, and then are followed with 20mg Atorvastatin during the entire study period.
Intensive statin
the Intensive Atorvastatin protocol indicates that once 80mg Atorvastatin will be administrated before CAG, and then will be followed with 20mg Atorvastatin daily during the entire study period.
Routine statin
1. Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls.
2. All subjects will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
3. the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.
Routine statin
the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.
Interventions
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Intensive statin
the Intensive Atorvastatin protocol indicates that once 80mg Atorvastatin will be administrated before CAG, and then will be followed with 20mg Atorvastatin daily during the entire study period.
Routine statin
the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
Yes
Sponsors
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National Natural Science Foundation of China
OTHER_GOV
Ji Huang
OTHER
Responsible Party
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Ji Huang
Attending Physician of Cardiology
Principal Investigators
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Hai-Yan Qian, MD,PhD
Role: STUDY_DIRECTOR
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Locations
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Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Ji Huang, MD
Role: primary
References
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Wojakowski W, Tendera M, Kucia M, Zuba-Surma E, Paczkowska E, Ciosek J, Halasa M, Krol M, Kazmierski M, Buszman P, Ochala A, Ratajczak J, Machalinski B, Ratajczak MZ. Mobilization of bone marrow-derived Oct-4+ SSEA-4+ very small embryonic-like stem cells in patients with acute myocardial infarction. J Am Coll Cardiol. 2009 Jan 6;53(1):1-9. doi: 10.1016/j.jacc.2008.09.029.
Other Identifiers
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TRAVEL-CAD
Identifier Type: -
Identifier Source: org_study_id