Statin and Post-interventional Coronary Microcirculation Dysfunction

Not Applicable

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

• Registration Number: NCT01751295
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-13
• Last Update Submitted: 2012-12-13
• Study First Posted: 2012-12-17
• Last Update Posted: 2012-12-17
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atorvastatin	Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI	PCI with atorvastatin pre-treatment group

Primary Outcome Measures

Name	Time	Method
Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel	within 1 year after PCI

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of