South East (Zuid Oost) Netherlands Heart Registry

NCT ID: NCT06512493

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 99999 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2050-01-01

Brief Summary

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).

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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Chronic Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht Universitair Medisch Centrum

UNKNOWN

Sponsor Role: collaborator

Zuyderland Medisch Centrum

OTHER

Sponsor Role: collaborator

VieCuri Medical Centre

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ZuyderlandMC

Heerlen, Limburg, Netherlands

Site Status: RECRUITING

MaastrichtUMC+

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

VieCuri

Venlo, Limburg, Netherlands

Site Status: RECRUITING

Radboud University Medical Centre

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

van Geuns

Role: CONTACT

robertjan.vangeuns@radboudumc.nl

(024) 3614153

Van 't Hof

Role: CONTACT

arnoud.vant.hof@mumc.nl

043 3872727

Facility Contacts

Arnoud van 't Hof, Prof.

Role: primary

Arnoud van 't Hof, prof

Role: primary

Wouter Remkes

Role: primary

Robert Jan M van Geuns, Prof. dr.

Role: primary

RobertJan.vanGeuns@radboudumc.nl

Other Identifiers

METCZ20200185

Identifier Type: -

Identifier Source: org_study_id