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

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT03671356
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2067

Inclusion Criteria

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

Exclusion Criteria

• no written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality	30 days	In-hospital mortality will be assessed and primarily reported

Secondary Outcome Measures

Name	Time	Method
Bleeding (according to BARC bleeding definition)	30 days and up to 5 years post procedure	in-hospital and long-term minor and major bleeding up to five years post procedure will be assessed and reported
TIA and Stroke	30 days and up to 5 years post procedure	in-hospital and long-term cerebrovascular events (TIA and stroke) 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 procedure	in-hospital and long-term acute and chronic kidney injury 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 procedure	in-hospital and long-term impact of interventional procedures on quality of life up to five years post procedure will be assessed and reported
Long-term mortality	up to 5 years post procedure	long-term mortality up to five years post procedure will be assessed and report

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Düsseldorf, Germany