Effects of Atorvastatin 10 mg Versus 40 mg in Eight Months Follow-up Coronary Flow Reserve and Bone Marrow Stem Cell Mobilization in Patients With Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Many data indicate that statins increase mobilization of bone marrow-derived stem cells, and
      circulating bone marrow-derived stem cells are capable of homing to sites of myocardial
      infarction and endothelial disruption, thereby restoring myocardial function and
      microvascular integrity after acute myocardial infarction. Atorvastatin is widely used in the
      treatment of hyperlipidemia, especially after acute myocardial infarction. High-dose
      atorvastatin has been known to stop the progression of atherosclerosis and to decrease the
      levels of inflammatory markers.

      The purpose of this prospective, randomized, single-blinded trial is to compare the effect of
      atorvastatin 10 mg versus 40 mg in restoring coronary flow reserve (CFR) and in serial bone
      marrow stem cell mobilization during the 8 months follow-up in patients with acute myocardial
      infarction.
    

Detailed description: 
      Percutaneous coronary intervention is considered as the gold standard for primary treatment
      after acute myocardial infarction, and clinical outcome and recovery of myocardial
      contractility after successful coronary intervention are influenced by the extent of
      microvascular damage. The use of intracoronary Doppler evaluation of infarct-related coronary
      artery allows direct assessment of microvascular integrity after acute myocardial infarction.
      The assessment of coronary flow reserve should be performed at least 24 hours after acute
      myocardial infarction, and we will evaluate coronary flow reserve 5 days after acute
      myocardial infarction. Intracoronary Doppler wire will be placed just distal to the stent,
      and intracoronary Doppler assessment is repeated 8 months after coronary stenting at the same
      point.

        1. Primary end point: Comparison of atorvastatin 10 mg versus 40 mg on 8 months follow-up
           coronary flow reserve (CFR) and on the serial changes in stem cell mobilization (CD34,
           CD117, CD133, CXCR4+, C-met) after acute myocardial infarction.

        2. Secondary end point: Comparison of atorvastatin 10 mg versus 40 mg on the changes in the
           levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin) and on the clinical
           events such as cardiac death, myocardial infarction, target vessel revascularization
           during the 8 months of follow-up.

      1) Study design

        -  Prospective, randomized, single-blinded study.

        -  Patients enrollment: 100 patients (50 patients in each group) considering 20% drop-out
           rate.

        -  After informed consent, patients will be randomly assigned to the Atorvastatin 10 mg
           Group or the Atorvastatin 40 mg Group.

           2) Study protocol

        -  After IRB approval, we will enroll within 10 months 100 acute myocardial infarction
           patients requiring stent implantation.

        -  Study follow-up period will be 8 months.

        -  Baseline clinical, laboratory, and angiographic parameters will be obtained at baseline
           and at 8 months follow-up. Out-patients follow-up will be scheduled at 4 weeks, 16
           weeks, 32 weeks after sirolimus-eluting stent implantation.

        -  We will compare atorvastatin 10 mg versus atorvastatin 40 mg on the changes in coronary
           flow reserve during the 8 months of follow-up. The serial changes (baseline, 24 hours,
           48 hours, 5 days, 8 months) in stem cell mobilization (CD34, CD117, CD133, CXCR4+,
           C-met) will be compared in addition to major adverse cardiac events (cardiac death,
           myocardial infarction, target vessel revascularization) and inflammatory markers (hsCRP,
           IL-6, TNF-α, adiponectin).
    

Intervention name(s): atorvastatin
Intervention type(s): Drug
Intervention description(s): atorvastatin 10 mg versus 40 mg during the 8 months of follow-up
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment