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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose Atorvastatin | Active Comparator | Arm of pre-procedural high dose atorvastatin loading |
|
| Control | Placebo Comparator | No pre-procedural high dose atorvastatin loading |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-procedural High dose atorvastatin loading | Drug | Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure | 1 year after index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bong-Ki Lee, MD, PhD | Contact | +82-10-6373-9290 | nicedr@nate.com |
| Name | Affiliation | Role |
|---|---|---|
| Bong-Ki Lee, MD, PhD | KangWon National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangwon National University Hospital | Recruiting | Chuncheon | 200-722 | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 1, 2015 | |
| Reset | Apr 13, 2015 | |
| Release | Aug 19, 2017 |
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|
| No pre-procedural high-dose atorvastatin loading | Drug | atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention |
|
|
| Reset | Feb 23, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 1, 2015 | Apr 13, 2015 | |||
| Aug 19, 2017 | Feb 23, 2018 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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