Statin and Post-interventional Coronary Microcirculation Dysfunction

Coronary Artery Disease Clinical Trial

Official title:

Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01751295
• Other study ID #: 2012-08-052
• Status: Active, not recruiting
• Phase: N/A
• First received: December 13, 2012
• Last updated: December 13, 2012
• Start date: December 2012
• Est. completion date: August 2014

Study information

• Verified date: December 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gang nam-Gu, Ilwon-Dong

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel		within 1 year after PCI	No
Secondary	Post-procedural troponin I		within 1 year after PCI	No
Secondary	Post-procedural FFR		within 1 year after PCI	No
Secondary	Post-procedural IMR comparison of target vessel with non-target vessel		within 1 year after PCI	No