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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by The Korean Society of Circulation.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Bong-Ki Lee, The Korean Society of Circulation Identifier:
First received: December 1, 2011
Last updated: December 11, 2011
Last verified: December 2011
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.

Condition Intervention
Acute Coronary Syndrome
Drug: Pre-procedural High dose atorvastatin loading
Drug: No pre-procedural high-dose atorvastatin loading

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by The Korean Society of Circulation:

Primary Outcome Measures:
  • Index of microcirculatory resistance (IMR) [ Time Frame: Immediately after percutaneous coronary intervention ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Lipitor (Pfizer)

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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01491256

Korea, Republic of
Kangwon National University Hospital
Chuncheon, Korea, Republic of, 200-722
Sponsors and Collaborators
The Korean Society of Circulation
Principal Investigator: Bong-Ki Lee, MD, PhD KangWon National University Hospital
  More Information

Responsible Party: Bong-Ki Lee, Assistance Professor of Medicine, Kangwon National University School of Medicine, The Korean Society of Circulation Identifier: NCT01491256     History of Changes
Other Study ID Numbers: RESIST-ACS 
Study First Received: December 1, 2011
Last Updated: December 11, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by The Korean Society of Circulation:
Index of microcirculatory resistance
drug-eluting stent
acute coronary syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on January 14, 2017