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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: risk score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 yeas of age, written informed consent, cardiac catheterization at university hospital Düsseldorf, Germany Exclusion Criteria: no written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: risk score|risk score|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | In-hospital mortality will be assessed and primarily reported | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding (according to BARC bleeding definition) | in-hospital and long-term minor and major bleeding up to five years post procedure will be assessed and reported | 30 days and up to 5 years post procedure | 
| Acute and chronic kidney injury (according to KDIGO definitions) | in-hospital and long-term acute and chronic kidney injury up to five years post procedure will be assessed and reported | 30 days and up to 5 years post procedure | 
| TIA and Stroke | in-hospital and long-term cerebrovascular events (TIA and stroke) up to five years post procedure will be assessed and reported | 30 days and up to 5 years post procedure | 
| Quality of life (assessed by standardized QoL surveys) | in-hospital and long-term impact of interventional procedures on quality of life up to five years post procedure will be assessed and reported | 30 days and up to 5 years post procedure | 
| Long-term mortality | long-term mortality up to five years post procedure will be assessed and report | up to 5 years post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risk score, risk management, NCDR, interventional cardiology