Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading

Study Overview
=================
Brief Summary
-----------------
Pre-treatment with statins decreased the incidence of cardiac enzyme increase after percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI myocardial damage. This study evaluates the effect of high dose atorvastatin pre-treatment on post-procedural index of microcirculatory resistance (IMR) values that are introduced for assessing the status of the microcirculation.

Detailed Description
-----------------
One hundred patients with non-ST elevation acute coronary syndrome will be randomly assigned to either high dose atorvastatin pre-treatment group(80 mg loading within 24 hours plus 40mg busting within 2 hours before PCI) or control group(atorvastatin 10mg administration within 24 hours before PCI). An intracoronary pressure/temperature sensor-tipped guidewire is used. Thermodilution curves are obtained during maximal hyperemia. The IMR was calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time. Creatine kinase-myocardial band(CK-MB) and CRP level will be measured at baseline and at 12 24 hours after PCI.

Official Title
-----------------
Randomized Comparison Multicenter Trial of High Dose Atorvastatin Pre-treatment on Microcirculatory Dysfunction After Drug-ElutIng Stent Implantation in Patients With Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: Pre-procedural High dose atorvastatin loading
* Drug: No pre-procedural high-dose atorvastatin loading


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of Non-ST elevation acute coronary syndrome planed to elective percutaneous coronary intervention Exclusion Criteria: ST elevation myocardial infarction Cardiogenic shock Congestive heart failure with pulmonary edema Severe left ventricular dysfunction (LVEF < 30%) History of previous coronary revascularization therapy chronic total coronary occlusion 3 vessel disease Target lesion at distal segments or branches Ostial lesion Excessive coronary calcification or thrombi Elevated transaminase Renal dysfunction (serum creatinine > 2.0mg/dL History of myopathy Contra-indication to anti-platelet therapy Not indicated for percutaneous coronary intervention Other co-morbidity with life expectancy less than 1 year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose Atorvastatin<br>Arm of pre-procedural high dose atorvastatin loading | Drug: Pre-procedural High dose atorvastatin loading<br>* Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention<br>* Other names: Lipitor (Pfizer);|
| Placebo Comparator: Control<br>No pre-procedural high dose atorvastatin loading | Drug: No pre-procedural high-dose atorvastatin loading<br>* atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention<br>* Other names: Lipitor (Pfizer);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index of microcirculatory resistance (IMR) | After stent implantation and adjunctive balloon dilatation, final angiogram will be taken. If the final angiogram shows successful results, IMR will be measured and the procedure will be finished. | Immediately after percutaneous coronary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure |  | 1 year after index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Index of microcirculatory resistance, atorvastatin, drug-eluting stent, acute coronary syndrome