Risk Management in Interventional Cardiology - a Quality Management Single-center Registry (NCDR)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: risk score

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 Type: Observational
• Enrollment (Actual): 2067

Contacts and Locations

• Study Contact: Name: Georg Wolff, MD; Phone Number: +492118118800; Email: ctsu@med.uni-duesseldorf.de
• Study Contact Backup: Name: Rabea Wagstaff, MA; Phone Number: +492118118800; Email: ctsu@med.uni-duesseldorf.de

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All consenting adult patients undergoing cardiac catheterization at University Hospital Düsseldorf, Germany

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no written informed consent

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Chair: Malte Kelm, MD, University Hospital Düsseldorf

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: risk score; interventional cardiology; risk management; NCDR
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 18-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No