Clinical trial NCT03065543: Hyperlipidemia Therapy TERCET Zabrze Registry
Official title: Hyperlipidemia Therapy in tERtiary Cardiological cEnTer Zabrze Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperlipidemias
Secondary Prevention
Keywords: Hyperlipidemias
Secondary prevention
high risk patients
very high risk patients
Lead sponsor: Silesian Centre for Heart Diseases
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is formed by all patients hospitalized in the 3-Dept of Cardiology Zabrze, Poland due to cardiovascular diseases and hyperlipidemia from 1st January 2006.

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:

1. 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
2. Assessment of the lipid profile of the severity of coronary artery disease in patients undergoing invasive diagnosis of coronary artery disease
3. 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.

Eligibility criteria: Inclusion Criteria:

* All patients with coronary artery disease with hyperlipidemia

Exclusion Criteria:

* No coronary artery disease

Primary outcomes:
measure: Evaluation of the impact of treatment on the lipid profile and long-term prognosis
timeFrame: 2006-2025
Secondary outcomes:
measure: Assessment of the lipid profile of the severity of coronary artery disease
timeFrame: 2006-2025
measure: Evaluation of trends in the treatment of lipid-lowering in patients in different years
timeFrame: 2006-2025
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Silesian Center for Heart Diseases
state: Upper Silesia
Study officials:
affiliation: 3rd Department of Cardiology, SMDZ in Zabrze, Medical University of Silesia, Katowice, Poland
name: Mariusz Gasior, prof.MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dyrbus K, Osadnik T, Desperak P, Desperak A, Gasior M, Banach M. Evaluation of dyslipidaemia and the impact of hypolipidemic therapy on prognosis in high and very high risk patients through the Hyperlipidaemia Therapy in tERtiary Cardiological cEnTer (TERCET) Registry. Pharmacol Res. 2018 Jun;132:204-210. doi: 10.1016/j.phrs.2017.12.015. Epub 2017 Dec 16.