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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01047176

Acronym

OPTIMA

Enrollment

602

Registered

2010-01-12

Start date

2009-12-31

Completion date

2011-12-31

Last updated

2012-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Dyslipidemia

Keywords

Statins, Coronary Heart Disease, Percutaneous coronary intervention (PCI)

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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 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 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
To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI.	3 visits for 12 months

Countries

Russia

Outcome results