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Statin and Post-interventional Coronary Microcirculation Dysfunction

NCT ID: NCT01751295

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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atorvastatin

PCI with atorvastatin pre-treatment group

Group Type ACTIVE_COMPARATOR

Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI

Intervention Type DRUG

control

PCI without atorvastatin pre-treatment group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI

Intervention Type DRUG

Other Intervention Names

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lipinon

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin-Ho Choi

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, Gang nam-Gu, Ilwon-Dong, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2012-08-052

Identifier Type: -

Identifier Source: org_study_id