HyperlipidemiasTERCETZabrzeNCT03065543
Hyperlipidemia Therapy TERCET Zabrze Registry
An observational study of Hyperlipidemias and Secondary Prevention, run by Silesian Centre for Heart Diseases at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemias, Secondary Prevention
- How many people
- 25,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2006to 31 Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients with coronary artery disease with hyperlipidemia
Who cannot join
- No coronary artery disease
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Silesian Center for Heart Diseases
Zabrze, Upper Silesia, 41-800
Krzysztof Dyrbus, +48600213030, dyrbusk@gmail.com
Mariusz Gasior, Prof,MD,PhD
About this study
Official title: 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:
- 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
Read the 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.
- Conditions
- Hyperlipidemias, Secondary Prevention
- Keywords
- Hyperlipidemias, Secondary prevention, high risk patients, very high risk patients
- Medical subject headings
- Hyperlipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2006-2025
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2006-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 Jan 2006
- Primary completion31 Dec 2016
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Silesian Centre for Heart Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Gasior, Silesian Centre for Heart Diseases
- Investigators
- Mariusz Gasior, prof.MD,PhD, Principal investigator, 3rd Department of Cardiology, SMDZ in Zabrze, Medical University of Silesia, Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065543
- Sponsor's protocol ID
- III KOK 01/2017
- Acronym
- TERCETZabrze
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29258913
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperlipidemia Therapy in tERtiary Cardiological cEnTer Zabrze Registry
- ClinicalTrials.gov ID
- NCT03065543
- Acronym / sponsor ID
- TERCETZabrze / III KOK 01/2017
- Conditions
- Hyperlipidemias, Secondary Prevention
- Keywords
- Hyperlipidemias, Secondary prevention, high risk patients, very high risk patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Silesian Centre for Heart DiseasesUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients with coronary artery disease with hyperlipidemia
Key exclusion criteria (1 listed)
- No coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Assessment of the lipid profile of the severity of coronary artery disease
Time frame: 2006-2025
Evaluation of trends in the treatment of lipid-lowering in patients in different years
Time frame: 2006-2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Derived from this study: PubMed 29258913Dyrbus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariusz Gasior, prof.MD,PhD principal investigator
3rd Department of Cardiology, SMDZ in Zabrze, Medical University of Silesia, Katowice, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemias and Secondary Prevention, run by Silesian Centre for Heart Diseases at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krzysztof Dyrbus, MD, PhD (+48600213030, dyrbusk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of treatment on the lipid profile and long-term prognosis (time frame: 2006-2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03065543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.