Clinical trial NCT01751295: Statin and Post-interventional Coronary Microcirculation Dysfunction
Official title: Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel
timeFrame: within 1 year after PCI
Secondary outcomes:
measure: Post-procedural troponin I
timeFrame: within 1 year after PCI
measure: Post-procedural FFR
timeFrame: within 1 year after PCI
measure: Post-procedural IMR comparison of target vessel with non-target vessel
timeFrame: within 1 year after PCI
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gang nam-Gu, Ilwon-Dong
Study officials:
References: