Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Clinical Trial
Official title:
Observational Prospective Study to esTIMAte the Rates of Outcomes in Patients Undergoing PCI (Percutaneuos Coronary Intervention) With Drug Eluting Stent (DES) Implantation Who Take Statins (OPTIMA II) - Follow-up
The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA study. In addition, the long-term effects of statins on LDL-cholesterol and different biomarkers in patients after drug-eluting stents implantation will be assessed. In addition, such project implementation will allow to clarify the treatment options used by Russian patients with CAD (Coronary Artery Disease) after drug-eluting stent implantation. The information received in this study will help to optimize management of Russian patients with CAD after PCI in order to improve prognosis and quality of life of these patients.
This project is 3-years follow-up of OPTIMA study. This is an observational
retro-prospective study based on the data collected during one visit: 4-year after PCI
performed at the Russian Cardiological Research Center (РКНПК). From the date of the study
start and until the end of the study investigators will enroll those patients participated
in OPTIMA study. Only patients, who consent to participate in the study and sign the
informed consent form after being informed by a physician on the objectives and methods of
the study, will be enrolled into this project.
This study is an observational one, and there is no intervention into routine clinical
practice either in terms of therapy, or special examinations. The main point of this project
is the data collection using the out-patient medical records or disease history of a
patient, as well as collection of data received during patient routine examination. Data
collection will be performed only once during single routine patient visit to treating
physician or hospitalized patient examination. Study participation will be finished after
this visit. Data collection will be performed at the visit 4 years after PCI and will
include medical history, current medications, physical examination, ECG (electrocardiogram)
and laboratory assessments.
The study will be conducted in Russian Federation. It is planned that 80-90% of patients
participated in OPTIMA study will be enrolled into current project. One clinical site -
Russian Cardiological Research Center (РКНПК) - is supposed to participate in this study.
The total period of the study is anticipated to be about 18 months.
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Observational Model: Cohort, Time Perspective: Prospective