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Risk Management in Interventional Cardiology - a Quality Management Single-center Registry

Risk Management in Interventional Cardiology - a Quality Management Single-center Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03671356
Acronym
NCDR
Enrollment
2067
Registered
2018-09-14
Start date
2017-09-01
Completion date
2018-12-31
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

risk score, risk management, NCDR, interventional cardiology

Brief summary

The validity and applicability of different clinical risk scoring models in a variety of settings of interventional cardiology is evaluated in a retrospective and continuing prospective single-center registry at University Hospital Düsseldorf. Risk-adapted safety interventions are additionally tested.

Detailed description

Beginning with a retrospective assessment of 2014-2017 and continuing with a prospective registry, clinical outcomes of interventional cardiac catheterization procedures at University Hospital Düsseldorf in a variety of settings (elective and emergency coronary procedures, structural and rhythmologic cardiac interventions etc.), will be evaluated. Different risk scoring models are recommended for risk stratification by cardiovascular societies (e.g. GRACE, CRUSADE, NCDR, ACEF, EUROScore scores) and will be evaluated for their applicability to contemporary and local clinical practice in interventional cardiology. Risk-adapted safety interventions (e.g. intensified monitoring, vascular access closure, renal protective measures) will be applied to all patients and will be evaluated for their impact on clinical outcomes.

Interventions

OTHERrisk score

risk score

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* \>18 yeas of age, written informed consent, cardiac catheterization at university hospital Düsseldorf, Germany

Exclusion criteria

* no written informed consent

Design outcomes

Primary

MeasureTime frameDescription
mortality30 daysIn-hospital mortality will be assessed and primarily reported

Secondary

MeasureTime frameDescription
Long-term mortalityup to 5 years post procedurelong-term mortality up to five years post procedure will be assessed and report
Bleeding (according to BARC bleeding definition)30 days and up to 5 years post procedurein-hospital and long-term minor and major bleeding up to five years post procedure will be assessed and reported
Acute and chronic kidney injury (according to KDIGO definitions)30 days and up to 5 years post procedurein-hospital and long-term acute and chronic kidney injury up to five years post procedure will be assessed and reported
TIA and Stroke30 days and up to 5 years post procedurein-hospital and long-term cerebrovascular events (TIA and stroke) up to five years post procedure will be assessed and reported
Quality of life (assessed by standardized QoL surveys)30 days and up to 5 years post procedurein-hospital and long-term impact of interventional procedures on quality of life up to five years post procedure will be assessed and reported

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026