Hyperlipidemia Therapy TERCET Zabrze Registry (TERCETZabrze)

Hyperlipidemia Therapy in tERtiary Cardiological cEnTer Zabrze Registry

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

Study Overview

• Status: Recruiting
• Conditions: Hyperlipidemias; Secondary Prevention

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 Type: Observational
• Enrollment (Anticipated): 25000

Contacts and Locations

• Study Contact: Name: Krzysztof Dyrbus, MD, PhD; Phone Number: +48600213030; Email: dyrbusk@gmail.com

Study Locations

• Poland
  • Upper Silesia
    • Zabrze, Upper Silesia, Poland, 41-800
      • Recruiting
      • Silesian Center for Heart Diseases
      • Contact: Krzysztof Dyrbus; Phone Number: +48600213030; Email: dyrbusk@gmail.com
      • Principal Investigator: Mariusz Gasior, Prof,MD,PhD
      • Sub-Investigator: Krzysztof Dyrbus, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• All patients with coronary artery disease with hyperlipidemia

Exclusion Criteria:

• No coronary artery disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the impact of treatment on the lipid profile and long-term prognosis	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.	2006-2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the lipid profile of the severity of coronary artery disease	A comparison of an initial lipid profile values (with an intense emphasis on the LDL-C), assayed by the standard laboratory techniques) and the coronary artery atherosclerosis extensity, and the long-term prognosis in a year after discharge from hospital. 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.	2006-2025
Evaluation of trends in the treatment of lipid-lowering in patients in different years	An observation of TCh, LDL-C, HDL-C and TG serum concentration values (measured by the standard laboratory assay techniques) depending on the period of the Registry function and the date of inclusion to the Registry. This part of the examination will answer how do the physicians adhere to the hyperlipidemia treatment guidelines in Poland and what are the trends in this therapy form.	2006-2025

Collaborators and Investigators

• Sponsor: Silesian Centre for Heart Diseases
• Investigators: Principal Investigator: Mariusz Gasior, prof.MD,PhD, 3rd Department of Cardiology, SMDZ in Zabrze, Medical University of Silesia, Katowice, Poland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2006
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (ACTUAL): February 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Secondary prevention; high risk patients; Hyperlipidemias; very high risk patients
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: III KOK 01/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No