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

Ji Huang

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Intensive statin; Drug: Routine statin

Study type: Interventional

Funder types: Other

Identifiers

NCT01633359

TRAVEL-CAD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Intensive statin

Experimental group

Description:

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.

Treatment:

Drug: Intensive statin

Routine statin

Experimental group

Description:

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.

Treatment:

Drug: Routine statin