Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading
Information source: The Korean Society of Circulation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndrome
Intervention: Pre-procedural High dose atorvastatin loading (Drug); No pre-procedural high-dose atorvastatin loading (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: The Korean Society of Circulation Official(s) and/or principal investigator(s): Bong-Ki Lee, MD, PhD, Principal Investigator, Affiliation: KangWon National University Hospital
Overall contact: Bong-Ki Lee, MD, PhD, Phone: +82-10-6373-9290, Email: nicedr@nate.com
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Index of microcirculatory resistance (IMR)
Secondary outcome: Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Bong-Ki Lee, MD, PhD, Phone: +82-10-6373-9290, Email: nicedr@nate.com
Kangwon National University Hospital, Chuncheon 200-722, Korea, Republic of; Recruiting Bong-Ki Lee, MD, PhD, Phone: +82-10-6373-9290, Email: nicedr@nate.com Bon-Kwon Koo, MD, PhD, Principal Investigator Chang-WooK Nam, MD, PhD, Principal Investigator Seung-Woon Rha, MD, PhD, 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, Principal Investigator
Additional Information
Starting date: February 2010
Last updated: December 11, 2011
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