Viewing Study NCT01491256



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Last Modification Date: 2024-10-26 @ 10:44 AM
Study NCT ID: NCT01491256
Status: UNKNOWN
Last Update Posted: 2011-12-13
First Post: 2011-12-01

Brief Title: Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading
Sponsor: The Korean Society of Circulation
Organization: The Korean Society of Circulation

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2011-12
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: RESIST-ACS
Brief 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
Detailed Description: One hundred patients with non-ST elevation acute coronary syndrome will be randomly assigned to either high dose atorvastatin pre-treatment group80 mg loading within 24 hours plus 40mg busting within 2 hours before PCI or control groupatorvastatin 10mg administration within 24 hours before PCI An intracoronary pressuretemperature 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 bandCK-MB and CRP level will be measured at baseline and at 1224 hours after PCI

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None