NCT03065543

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. 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. 2.Assessment of the lipid profile of the severity of coronary artery disease in patients undergoing invasive diagnosis of coronary artery disease
  3. 3.Evaluation of trends in the treatment of lipid-lowering in patients in different years

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

11 years

First QC Date

February 7, 2017

Last Update Submit

February 22, 2017

Conditions

HyperlipidemiasSecondary Prevention

Keywords

HyperlipidemiasSecondary preventionhigh risk patientsvery high risk patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients with coronary artery disease with hyperlipidemia

You may not qualify if:

  • No coronary artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silesian Center for Heart Diseases

Zabrze, Upper Silesia, 41-800, Poland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29258913DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mariusz Gasior, prof.MD,PhD

    3rd Department of Cardiology, SMDZ in Zabrze, Medical University of Silesia, Katowice, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Krzysztof Dyrbus, MD, PhD

CONTACT

+48600213030dyrbusk@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. of Medicine, Head of 3rd Department of Cardiology, SMDZ in Zabrze, Medical University of Silesia, Katowice, Poland

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 28, 2017

Study Start

January 1, 2006

Primary Completion

December 31, 2016

Study Completion

December 31, 2025

Last Updated

February 28, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)