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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by The Korean Society of Circulation.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Bong-Ki Lee, The Korean Society of Circulation
ClinicalTrials.gov Identifier:
NCT01491256
First received: December 1, 2011
Last updated: December 11, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Drug: Pre-procedural High dose atorvastatin loading
Drug: No pre-procedural high-dose atorvastatin loading

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The Korean Society of Circulation:

Primary Outcome Measures:
  • Index of microcirculatory resistance (IMR) [ Time Frame: Immediately after percutaneous coronary intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High dose Atorvastatin
Arm of pre-procedural high dose atorvastatin loading
Drug: Pre-procedural High dose atorvastatin loading
Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention
Other Name: Lipitor (Pfizer)
Placebo Comparator: Control
No pre-procedural high dose atorvastatin loading
Drug: No pre-procedural high-dose atorvastatin loading
atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention
Other Name: Lipitor (Pfizer)

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491256

Contacts
Contact: Bong-Ki Lee, MD, PhD +82-10-6373-9290 nicedr@nate.com

Locations
Korea, Republic of
Kangwon National University Hospital Recruiting
Chuncheon, Korea, Republic of, 200-722
Contact: Bong-Ki Lee, MD, PhD    +82-10-6373-9290    nicedr@nate.com   
Principal Investigator: 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         
Sponsors and Collaborators
The Korean Society of Circulation
Investigators
Principal Investigator: Bong-Ki Lee, MD, PhD KangWon National University Hospital
  More Information

No publications provided

Responsible Party: Bong-Ki Lee, Assistance Professor of Medicine, Kangwon National University School of Medicine, The Korean Society of Circulation
ClinicalTrials.gov Identifier: NCT01491256     History of Changes
Other Study ID Numbers: RESIST-ACS
Study First Received: December 1, 2011
Last Updated: December 11, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by The Korean Society of Circulation:
Index of microcirculatory resistance
atorvastatin
drug-eluting stent
acute coronary syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014