Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading (RESIST-ACS)

The Korean Society of Circulation

Status: Unknown

Conditions: Acute Coronary Syndrome

Treatments: Drug: No pre-procedural high-dose atorvastatin loading; Drug: Pre-procedural High dose atorvastatin loading

Study type: Interventional

Funder types: Other

Identifiers

NCT01491256

RESIST-ACS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

High dose Atorvastatin

Active Comparator group

Description:

Arm of pre-procedural high dose atorvastatin loading

Treatment:

Drug: Pre-procedural High dose atorvastatin loading

Control

Placebo Comparator group

Description:

No pre-procedural high dose atorvastatin loading

Treatment:

Drug: No pre-procedural high-dose atorvastatin loading