Hyperlipidemia Therapy in tERtiary Cardiological cEnTer Zabrze Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 25,000
- Locations
- 1
- Primary Endpoint
- Evaluation of the impact of treatment on the lipid profile and long-term prognosis
Study Overview
Brief Summary
A study conducted to evaluate the efficacy of lipid-lowering therapy in patients with high and very high risk treated by interventional cardiology. Study endpoints:
- Achievement of the target LDL-C at 1-year follow-up LDL-C <70 mg / dl in the group of very high-risk and LDL-C <100 mg / dL in high-risk patients
- Assessment of the lipid profile of the severity of coronary artery disease in patients undergoing invasive diagnosis of coronary artery disease
- Evaluation of trends in the treatment of lipid-lowering in patients in different years
Detailed Description
The TERCET Zabrze Registry is an observational study of all patients hospitalized due to the cardiovascular diseases. The date include information on the hyperlipidaemia treatment, clinical characteristics, any treatment modalities and prognosis in this population. Data collection is patient-based (not event-based).
The study population is formed by all-comer patients hospitalized in cardiology wards and intensive cardiac care units with a diagnosis of coronary disease, both stable angina, and acute coronary syndromes (ACS). For the purpose of this study hyperlipidaemia is defined in accordance with European Society of Cardiology guidelines.
Complete patient demographics; medical history, complete hospitalization data (diagnostic and therapeutic), in-hospital and out-hospital results are collected in an electronic form by the attending physician. The patients are under constant follow-up for all cause mortality and major adverse events.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients with coronary artery disease with hyperlipidemia
Exclusion Criteria
- •No coronary artery disease
Outcomes
Primary Outcomes
Evaluation of the impact of treatment on the lipid profile and long-term prognosis
Time Frame: 2006-2025
The registry compares lipid profile values (assayed by the standard laboratory techniques): total cholesterol (TCh), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and TG (triglycerides) with an intense emphasis on the LDL-C value measured during the inclusion to the registry, with MACE (Major Adverse Cardiac Events) and a control lipid profile measurement, depending on the therapy form (revascularization followed by an intensified pharmacological treatment/revascularization only/pharmacological treatment only). The information regarding MACE is acquired from the NFZ (National Health Fund; polish healthcare provider). Using the statistical analysis the influence of an optimised hyperlipidemia treatment on the long-term prognosis will be assessed.
Secondary Outcomes
- Assessment of the lipid profile of the severity of coronary artery disease(2006-2025)
- Evaluation of trends in the treatment of lipid-lowering in patients in different years(2006-2025)
Investigators
Mariusz Gasior
Prof. of Medicine, Head of 3rd Department of Cardiology, SMDZ in Zabrze, Medical University of Silesia, Katowice, Poland
Silesian Centre for Heart Diseases