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

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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01491256

Acronym

RESIST-ACS

Enrollment

100

Registered

2011-12-13

Start date

2010-02-28

Completion date

2012-02-29

Last updated

2011-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

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

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.

Interventions

DRUGPre-procedural High dose atorvastatin loading

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

DRUGNo pre-procedural high-dose atorvastatin loading

atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Index of microcirculatory resistance (IMR)	Immediately after percutaneous coronary intervention	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

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

Countries

South Korea

Contacts

Primary ContactBong-Ki Lee, MD, PhD

nicedr@nate.com+82-10-6373-9290

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026