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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: Routine statin; Drug: Intensive statin

• Registration Number: NCT01633359
• Lead Sponsor: Ji Huang

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.

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 Timeline

• Study First Submitted: 2012-05-31
• Status Verified: 2012-07
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-04
• Last Update Submitted: 2012-07-04
• Last Update Posted: 2012-07-06
• Primary Completion: 2012-12
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine statin	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.
Intensive statin	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.

Primary Outcome Measures

Name	Time	Method
Number of peripheral blood VSELs	during 1 year after enrollment	All subject will receive the follow-up for 1 year, and peripheral blood VSELs are counted.

Secondary Outcome Measures

Name	Time	Method
MACE	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.

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China