Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading

Acute Coronary Syndrome Clinical Trial

— RESIST-ACS  

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01491256
• Other study ID #: RESIST-ACS
• Status: Unknown status
• Phase: N/A
• First received: December 1, 2011
• Last updated: December 11, 2011
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: December 2011
• Source: The Korean Society of Circulation
• Contact: Bong-Ki Lee, MD, PhD
• Phone: +82-10-6373-9290
• Email: nicedr[@]nate.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Pre-procedural High dose atorvastatin loading
Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention
• No pre-procedural high-dose atorvastatin loading
atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention

Locations

Country	Name	City	State
Korea, Republic of	Kangwon National University Hospital	Chuncheon

Sponsors (1)

Lead Sponsor	Collaborator
The Korean Society of Circulation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure		1 year after index procedure