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NCT03091829 Clinical Trial

Chest Pain Unit II Register

Chest Pain Clinical Trial

Official title:
Chest Pain Unit II Register - CPU II Register

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03091829
Other study ID # CPU II Register
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2016
Est. completion date December 2019

Study information
Verified date September 2019
Source Stiftung Institut fuer Herzinfarktforschung
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Multicentric, prospective, non-interventional observational study with two parts:

1. A register of quality assurance within the recertification of clinics

2. An extended register with scientific protocol.

Description:

1. Quality assurance

As a quality-assuring basic register, the CPU II register checks the extent to which certified Chest Pain Units fulfill the criteria published by the DGK. In particular, the following quality dimensions are evaluated:

- Indication quality

- Diagnostic quality

- Therapeutic quality

- Structural quality / networking

2. Platform for projects with a scientific focus

The CPU II register and the infrastructure provided are a platform for further projects with scientific questions (scientific protocol = WP):

WP: Clinical history after CPU (PCI data / discharge / 12-month FUP) in patients with leading cardiac diagnosis

Recruitment information / eligibility
Status Completed
Enrollment 4829
Est. completion date December 2019
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- CPU patient

- > 18 years

- Written consent of the patient

Exclusion Criteria:

- Denied consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Klinikum Links der Weser Bremen Bremen
Germany Klinikum der Johannes-Gutenberg-Universität, 2. Med. Klinik Mainz RLP
Germany Städtisches Klinikum Neuperlach Munchen Bayern

Sponsors (1)
Lead Sponsor Collaborator
Stiftung Institut fuer Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fulfillment of DGK criteria Quality assurance: Fulfillment of the recertification criteria of the german society for cardiology 12 months
Primary Clinical progress after CPU Scientific protocol: Documentation of the clinical progress after CPU 12 months
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