South East (Zuid Oost) Netherlands Heart Registry (ZON-HR)

July 24, 2024 updated by: Radboud University Medical Center

South East (Zuid Oost) Netherlands Heart Registry (ZON-HR)

Rationale: Patients undergoing percutaneous coronary intervention (PCI) for chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) have a residual risk of ischemic events after PCI due to the progression of atherosclerosis in and outside the stented segments. The residual risk is affected by thrombotic, lipid, inflammation and diabetic risk factors. Secondary prevention after PCI is therefore of major importance to reduce complications and improve the patients' prognosis.

Objective: To provide an extensive overview on the quality of secondary prevention and personalized medicine, a consortium in the South East Netherlands has created a PCI registry, the "Zuid Oost Nederland Hart Registratie" (ZON-HR).

Study Overview

Status

Recruiting

Conditions

Detailed Description

Rationale: Patients undergoing percutaneous coronary intervention (PCI) for chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) have a residual risk of ischemic events after PCI due to the progression of atherosclerosis in and outside the stented segments. The residual risk is affected by thrombotic, lipid, inflammation and diabetic risk factors. Secondary prevention after PCI is therefore of major importance to reduce complications and improve the patients' prognosis. Antithrombotic treatment plays a major role in the reduction of thromboembolic events and is therefore key in secondary prevention. However, this treatment increases the risk of bleeding complications. Therefore, a personalized antiplatelet strategy is recommended by the guidelines. Together with the antithrombotic treatment, lipid management is the cornerstone of secondary prevention. As low density lipoproteins cholesterol (LDL-C) increases the risk for atherosclerotic cardiovascular disease, the current ESC guidelines recommend a LDL-C value <1.4mmol/L in patients undergoing PCI. Personalized medicine in which the treatment and lifestyle advice after PCI is adjusted on the patients' risk factors such as high bleeding- or thromboembolic risk, high LDL cholesterol levels, hypertension or the presence of diabetes mellitus (DM) is of major importance to lower the residual risk of complications and revascularisation. However, due to the large amount of risk factors that should be considered, personalized medicine is challenging which can lead to under treatment.

Objective: To maintain and improve quality of care throughout the Netherlands, all interventional centres deliver data regarding patient- and procedural characteristics and follow-up after PCI to the Netherland Heart Registry (NHR). The NHR processes the data and provides these centres with feedback. (16) However, the registration of baseline-, procedural- and follow-up parameters by the NHR is concise and mainly focuses on mortality and (ischemia driven) revascularisation. To enhance the potency of this PCI registry, a consortium in the South East region of the Netherlands has created an extended version: The "Zuid Oost Nederland Hart Registratie" (ZON-HR). With this comprehensive registry, the ZON-HR provides a more extensive overview on the quality of secondary prevention and personalized medicine. Furthermore, the ZON-HR consortium aims to improve secondary prevention post-PCI by stimulating a personalized approach. Also, it will provide a platform for research regarding secondary prevention.

Study Type

Observational

Enrollment (Estimated)

99999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419PC
        • Recruiting
        • ZuyderlandMC
        • Contact:
          • Arnoud van 't Hof, Prof.
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • MaastrichtUMC+
        • Contact:
          • Arnoud van 't Hof, prof
      • Venlo, Limburg, Netherlands, 5912 BL
        • Recruiting
        • VieCuri
        • Contact:
          • Wouter Remkes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

All patients undergoing PCI are included in the registry. In line with the NHR, failed PCI attempts are considered as a performed PCI as long as a coronary wire has been inserted in the target vessel.

Description

No in- or exclusion criteria are applied to gain 100% registration in order to prevent bias.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with
Time Frame: 1 or 2 years
  • all- cause mortality
  • Myocardial infarction
  • Stent thrombosis
  • Stroke
  • Revascularisation
  • All bleeding events requiring medical evaluation
1 or 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

VieCuri Medical Centre
Zuyderland Medisch Centrum
Maastricht Universitair Medisch Centrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Estimated)

January 1, 2050

Study Completion (Estimated)

January 1, 2050

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METCZ20200185

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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