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

Coronary Artery Disease Clinical Trial

— VSEL-CAD  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01633359
• Other study ID #: TRAVEL-CAD
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 31, 2012
• Last updated: July 4, 2012
• Start date: July 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2012
• Source: Beijing Anzhen Hospital
• Contact: Ji Huang, MD
• Phone: 86-10-64456535
• Email: salyherry[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• Routine statin
the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Ji Huang	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (1)

Wojakowski W, Tendera M, Kucia M, Zuba-Surma E, Paczkowska E, Ciosek J, Halasa M, Król 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of peripheral blood VSELs	All subject will receive the follow-up for 1 year, and peripheral blood VSELs are counted.	during 1 year after enrollment	Yes
Secondary	MACE	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.	During 1 year in the study period	Yes