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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

Page last updated: August 23, 2015

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