NCT06512493

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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
99,999

participants targeted

Target at P75+ for all trials

Timeline
288mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

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 Progress19%
Nov 2020Jan 2050

Study Start

First participant enrolled

November 1, 2020

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
25.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2050

Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

29.2 years

First QC Date

July 16, 2024

Last Update Submit

July 24, 2024

Conditions

Keywords

percutaneous coronary interventionsecondary preventionchronic coronary syndromeacute coronary syndromepersonalized medicine

Outcome Measures

Primary Outcomes (1)

  • Number of patients with

    * all- cause mortality * Myocardial infarction * Stent thrombosis * Stroke * Revascularisation * All bleeding events requiring medical evaluation

    1 or 2 years

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

ZuyderlandMC

Heerlen, Limburg, 6419PC, Netherlands

RECRUITING

MaastrichtUMC+

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

VieCuri

Venlo, Limburg, 5912 BL, Netherlands

RECRUITING

Radboud University Medical Centre

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 22, 2024

Study Start

November 1, 2020

Primary Completion (Estimated)

January 1, 2050

Study Completion (Estimated)

January 1, 2050

Last Updated

July 25, 2024

Record last verified: 2024-07

Locations