Observational Study to Estimate the Rates of Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI) With Drug Eluting Stent (DES) Implantation Who Take Statins

Study Overview
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Brief Summary
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To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.

Official Title
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Observational Prospective Study to esTIMAte the Rates of Outcomes in Patients Undergoing PCI With Drug Eluting Stent (DES) Implantation Who Take Statins

Conditions
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Dyslipidemia, Coronary Heart Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable angina with indication to PCI Hospitalization to Russian Cardiological Research Center (РКНПК) for PCI procedure with drug-eluting stents implantation Statin therapy initiated for at least one month prior to PCI Written informed consent provided prior the start of participation in the study. Exclusion Criteria: Subjects who are unwilling or unable to provide informed consent. Presence of ACS during the current hospitalization Severe CHF (NYHA III/IV) or LVEF<40 % Stroke within 6 months before PCI Acute or chronic inflammatory disease Anti-inflammatory medications intake, with the exception of aspirin Severe liver or muscle disease Severe kidney disease / renal failure with creatinine > 3 mg/dl History of oncologic disease Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Male or female > 18 year of age with indication to PCI | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins. |  | 3 visits for 12 month (before and after PCI) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate prognostic factors (demographic, co-morbidity, smoking, LDL-C, inflammatory and cardiac markers) in patients undergoing PCI with drug eluting stent (DES) implantation who take statins and their association with PCI (MACCE) outcomes |  | 3 visits for 12 month | 
| To estimate Low Density Lipoprotein Cholesterol (LDL-C) target level achievement and lipid-lowering therapy details in patients taking standard lipid lowering therapy prior the PCI. |  | 3 visits for 12 months | 
| To estimate inflammatory markers (C-reactive protein (CRP) and Leukocytes) in patients prior and after PCI. |  | 3 visits for 12 months | 
| To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI. |  | 3 visits for 12 months | 
| To study lipoprotein associated phospholipase A2 (Lp PLA2) in patients before PCI and its' association with PCI outcome. |  | 3 visits for 12 months | 
| To study the rate of early and late stent thrombosis according to ARC classification |  | 3 visits for 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Statins, Coronary Heart Disease, Percutaneous coronary intervention (PCI)