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OpenTrials
Completed

NCT Number: NCT03671356

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

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no written informed consent

Treatment and study plan

risk score

Other

risk score

Primary outcomes

  1. mortality

    Time frame: 30 days

    In-hospital mortality will be assessed and primarily reported

Secondary outcomes

  1. Bleeding (according to BARC bleeding definition)

    Time frame: 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

  2. Acute and chronic kidney injury (according to KDIGO definitions)

    Time frame: 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

  3. TIA and Stroke

    Time frame: 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

  4. Quality of life (assessed by standardized QoL surveys)

    Time frame: 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

  5. Long-term mortality

    Time frame: up to 5 years post procedure

    long-term mortality up to five years post procedure will be assessed and report

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Acronym: NCDR

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2018
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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