Statin and Post-interventional Coronary Microcirculation Dysfunction

Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction

The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI

Detailed Description

Development of peri-procedural myocardial infarction following percutaneous coronary intervention (PCI) is not uncommon and affects long-term prognosis. Clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. The mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. However the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet.

In this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. At the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. Percutaneous coronary intervention (PCI) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. When PCI is performed, fractional flow reserve (FFR) and index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 year.

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gang nam-Gu, Ilwon-Dong
    • Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of, 135-710
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A. Finished informed consent
• B. Stable angina with clinical indication of coronary angiography
• C. Age ≥ 21 year and ≤ 80 year

Exclusion Criteria:

• A.Without informed consent
• B.PCI target lesion is not adequate or not indicated for FFR/IMR study
• C.Prior myocardial infarction or interventional procedure for PCI target vessel
• D.Myocardial infarction within 30 days
• E.Usage of statin, current or within 1 month
• F.Prior bypass surgery
• G.Impaired renal function (Creatinine > 2.0 mg/dL)
• H.Impaired left ventricular function (ejection fraction < 40%)
• I.Active hepatitis or abnormal hepatic transaminase level (> 3 ULN)
• J.Contraindication for long-term antiplatelet agent or statin
• K.Planning or potential of pregnancy
• L.Neoplastic disease without evidence of treatment completion
• M.Impaired general condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: atorvastatin; PCI with atorvastatin pre-treatment group	Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI; Other Names: lipinon
No Intervention: control; PCI without atorvastatin pre-treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel	within 1 year after PCI

Secondary Outcome Measures

Outcome Measure	Time Frame
Post-procedural troponin I	within 1 year after PCI
Post-procedural FFR	within 1 year after PCI
Post-procedural IMR comparison of target vessel with non-target vessel	within 1 year after PCI

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 13, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 2012-08-052