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

Cardiovascular Diseases Clinical Trial

— NCDR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671356
• Other study ID #: 18-007
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2024
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2067
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• no written informed consent

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• risk score
risk score

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	In-hospital mortality will be assessed and primarily reported	30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Long-term mortality	long-term mortality up to five years post procedure will be assessed and report	up to 5 years post procedure