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The Association Between Very Small Embryonic-like Stem Cells and the Prognosis of Coronary Artery Disease Patients (VSEL-CAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01633359
Recruitment Status : Unknown
Verified July 2012 by Ji Huang, Beijing Anzhen Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 4, 2012
Last Update Posted : July 6, 2012
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Ji Huang, Beijing Anzhen Hospital

Study Description
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Brief Summary:
Hypothesis: Peripheral blood Very Small Embryonic-like Stem Cells (VSELs) are different in coronary artery disease (CAD) patients from those without CAD, which might account for the benefits of Atorvastatin in CAD patients.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Intensive statin Drug: Routine statin Phase 4

Detailed Description:
  1. Hypothesis: The VSELs might be mobilized in the situation of cardiac ischemia in CAD patients. In addition, the benefits derived from Atorvastatin administration in CAD patients may be related to VSELs via sCD40L-SDF1/CXCR4 signal pathway.

  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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Randomly Controlled Clinical Trial of the Association Between Very Small Embryonic-like Stem Cells and the Prognosis of Coronary Artery Disease Patients
Study Start Date : July 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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.
Other Name: Intensive Atorvastatin
Experimental: 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.
 Drug: Routine statin
the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.
Other Name: Routine Atorvastatin.


Outcome Measures
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Primary Outcome Measures :
  1. Number of peripheral blood VSELs [ Time Frame: during 1 year after enrollment ]
    All subject will receive the follow-up for 1 year, and peripheral blood VSELs are counted.


Secondary Outcome Measures :
  1. MACE [ Time Frame: During 1 year in the study period ]
    All subject 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • CAD patients receiving coronary angiography (CAG) as positive subjects, 100 as control who are negative for CAG.

Exclusion Criteria:

  • Infectious diseases, immunologically mediated disease, serious liver diseases, serious kidney diseases, malignant tumor, thrombocytopenia, pregnancy, occluded peripheral arterial diseases, bleeding or blood transfusion in the latest 2 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633359


Contacts
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Contact: Ji Huang, MD 86-10-64456535 salyherry@163.com

Locations
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China, Beijing
Beijing Anzhen Hospital
Beijing, Beijing, China, 100029
Contact: Ji Huang, MD    86-10-64456535    salyherry@163.com   
Principal Investigator: Ji Huang, MD         
Sponsors and Collaborators
Ji Huang
National Natural Science Foundation of China
Investigators
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Study Director: Hai-Yan Qian, MD,PhD Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
More Information
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Publications:

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Responsible Party: Ji Huang, Attending Physician of Cardiology, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT01633359    
Other Study ID Numbers: TRAVEL-CAD
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors