NCT03671356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,067

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

August 21, 2018

Last Update Submit

March 14, 2024

Conditions

Cardiovascular Diseases

Keywords

risk scorerisk managementNCDRinterventional cardiology

Outcome Measures

Primary Outcomes (1)

  • mortality

    In-hospital mortality will be assessed and primarily reported

    30 days

Secondary Outcomes (5)

  • Bleeding (according to BARC bleeding definition)

    30 days and up to 5 years post procedure

  • Acute and chronic kidney injury (according to KDIGO definitions)

    30 days and up to 5 years post procedure

  • TIA and Stroke

    30 days and up to 5 years post procedure

  • Quality of life (assessed by standardized QoL surveys)

    30 days and up to 5 years post procedure

  • Long-term mortality

    up to 5 years post procedure

Interventions

risk scoreOTHER

risk score

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • no written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Risk Factors

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Malte Kelm, MD

    Heinrich-Heine University, Duesseldorf

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2018

First Posted

September 14, 2018

Study Start

September 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

DE(1)