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

This study is not yet open for participant recruitment.
Verified July 2012 by Beijing Anzhen Hospital
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Ji Huang, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT01633359
First received: May 31, 2012
Last updated: July 4, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Drug: Intensive statin
Drug: Routine statin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Anzhen Hospital:

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


Secondary Outcome Measures:
  • MACE [ Time Frame: During 1 year in the study period ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633359

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

Locations
China, Beijing
Beijing Anzhen Hospital Not yet recruiting
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
Study Director: Hai-Yan Qian, MD,PhD Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  More Information

Publications:

Responsible Party: Ji Huang, Attending Physician of Cardiology, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT01633359     History of Changes
Other Study ID Numbers: TRAVEL-CAD
Study First Received: May 31, 2012
Last Updated: July 4, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
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
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013