Hyperlipidemia Therapy TERCET Zabrze Registry

Hyperlipidemias Clinical Trial

— TERCETZabrze  

Official title:

Hyperlipidemia Therapy in tERtiary Cardiological cEnTer Zabrze Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03065543
• Other study ID #: III KOK 01/2017
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2017
• Last updated: February 22, 2017
• Start date: January 1, 2006
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2017
• Source: Silesian Centre for Heart Diseases
• Contact: Krzysztof Dyrbus, MD, PhD
• Phone: +48600213030
• Email: dyrbusk[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with coronary artery disease with hyperlipidemia

Exclusion Criteria:

• No coronary artery disease

Related Conditions & MeSH terms

• Hyperlipidemias
• Secondary Prevention

Locations

Country	Name	City	State
Poland	Silesian Center for Heart Diseases	Zabrze	Upper Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Silesian Centre for Heart Diseases

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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