Statin and Post-interventional Coronary Microcirculation Dysfunction

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.

Detailed Description
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Development of peri-procedural myocardial infarction following percutaneous coronary intervention (PCI) is not uncommon and affects long-term prognosis. Clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. The mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. However the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet. In this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. At the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. Percutaneous coronary intervention (PCI) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. When PCI is performed, fractional flow reserve (FFR) and index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 year.

Official Title
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Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. Finished informed consent B. Stable angina with clinical indication of coronary angiography C. Age ≥ 21 year and ≤ 80 year Exclusion Criteria: A.Without informed consent B.PCI target lesion is not adequate or not indicated for FFR/IMR study C.Prior myocardial infarction or interventional procedure for PCI target vessel D.Myocardial infarction within 30 days E.Usage of statin, current or within 1 month F.Prior bypass surgery G.Impaired renal function (Creatinine > 2.0 mg/dL) H.Impaired left ventricular function (ejection fraction < 40%) I.Active hepatitis or abnormal hepatic transaminase level (> 3 ULN) J.Contraindication for long-term antiplatelet agent or statin K.Planning or potential of pregnancy L.Neoplastic disease without evidence of treatment completion M.Impaired general condition

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: atorvastatin<br>PCI with atorvastatin pre-treatment group | Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI<br> <br> * Other names: lipinon;|
| No Intervention: control<br>PCI without atorvastatin pre-treatment group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel |  | within 1 year after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-procedural troponin I |  | within 1 year after PCI | 
| Post-procedural FFR |  | within 1 year after PCI | 
| Post-procedural IMR comparison of target vessel with non-target vessel |  | within 1 year after PCI |