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

Primary Purpose

Acute Coronary Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Pre-procedural High dose atorvastatin loading

No pre-procedural high-dose atorvastatin loading

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Index of microcirculatory resistance, atorvastatin, drug-eluting stent, acute coronary syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kangwon National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

High dose Atorvastatin

Control

Arm Description

Arm of pre-procedural high dose atorvastatin loading

No pre-procedural high dose atorvastatin loading

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure

Full Information

NCT ID

NCT01491256

First Posted

December 1, 2011

Last Updated

December 11, 2011

Sponsor

The Korean Society of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT01491256

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

February 2010 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

February 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Korean Society of Circulation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Index of microcirculatory resistance, atorvastatin, drug-eluting stent, acute coronary syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High dose Atorvastatin

Arm Type

Active Comparator

Arm Description

Arm of pre-procedural high dose atorvastatin loading

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

No pre-procedural high dose atorvastatin loading

Intervention Type

Drug

Intervention Name(s)

Pre-procedural High dose atorvastatin loading

Other Intervention Name(s)

Lipitor (Pfizer)

Intervention Description

Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention

Intervention Type

Drug

Intervention Name(s)

No pre-procedural high-dose atorvastatin loading

Other Intervention Name(s)

Lipitor (Pfizer)

Intervention Description

atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention

Primary Outcome Measure Information:

Title

Index of microcirculatory resistance (IMR)

Description

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.

Time Frame

Immediately after percutaneous coronary intervention

Secondary Outcome Measure Information:

Title

Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure

Time Frame

1 year after index procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bong-Ki Lee, MD, PhD

Phone

+82-10-6373-9290

nicedr@nate.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bong-Ki Lee, MD, PhD

Organizational Affiliation

KangWon National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kangwon National University Hospital

City

Chuncheon

ZIP/Postal Code

200-722

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bong-Ki Lee, MD, PhD

Phone

+82-10-6373-9290

nicedr@nate.com

First Name & Middle Initial & Last Name & Degree

Bon-Kwon Koo, MD, PhD

First Name & Middle Initial & Last Name & Degree

Chang-WooK Nam, MD, PhD

First Name & Middle Initial & Last Name & Degree

Seung-Woon Rha, MD, PhD

First Name & Middle Initial & Last Name & Degree

Joon-Hyung Doh, MD, PhD

First Name & Middle Initial & Last Name & Degree

Woo-Young Chung, MD, PhD

First Name & Middle Initial & Last Name & Degree

Seung-Jae Tahk, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jin-Bae Lee, MD, PhD

First Name & Middle Initial & Last Name & Degree

Ki-Dong Yoo, MD, PhD

12. IPD Sharing Statement

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

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