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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Pre-procedural High dose atorvastatin loading; Drug: No pre-procedural high-dose atorvastatin loading

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bong-Ki Lee, MD, PhD; Phone Number: +82-10-6373-9290; Email: nicedr@nate.com

Study Locations

• Korea, Republic of
  • Chuncheon, Korea, Republic of, 200-722
    • Recruiting
    • Kangwon National University Hospital
    • Principal Investigator: Chang-Wook Nam, MD, PhD
    • Principal Investigator: Seung-Woon Rha, MD, PhD
    • Contact: Bong-Ki Lee, MD, PhD; Phone Number: +82-10-6373-9290; Email: nicedr@nate.com
    • Principal Investigator: Joon-Hyung Doh, MD, PhD
    • Principal Investigator: Woo-Young Chung, MD, PhD
    • Principal Investigator: Seung-Jae Tahk, MD, PhD
    • Principal Investigator: Jin-Bae Lee, MD, PhD
    • Principal Investigator: Ki-Dong Yoo, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High dose Atorvastatin; Arm of pre-procedural high dose atorvastatin loading	Drug: Pre-procedural High dose atorvastatin loading; Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention; Other Names: Lipitor (Pfizer)
Placebo Comparator: Control; No pre-procedural high dose atorvastatin loading	Drug: No pre-procedural high-dose atorvastatin loading; atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention; 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	Time Frame
Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure	1 year after index procedure

Collaborators and Investigators

• Sponsor: The Korean Society of Circulation

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Anticipated): February 1, 2012

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: December 11, 2011
• First Posted (Estimate): December 13, 2011

Study Record Updates

• Last Update Posted (Estimate): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 11, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: acute coronary syndrome; drug-eluting stent; atorvastatin; Index of microcirculatory resistance
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: RESIST-ACS