German Chest Pain Unit (CPU)-Register

Chest Pain Clinical Trial

Official title:

Deutsches CPU-Register. Unterstützt Durch Die Deutsche Gesellschaft für Kardiologie.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197716
• Other study ID #: German CPU-Register
• Status: Completed
• Phase: N/A
• First received: September 7, 2010
• Last updated: June 23, 2016
• Start date: December 2008
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The Chest Pain Unit (CPU) register is a nationwide scientific investigation, in which data concerning the hospital-stay within the Chest Pain Unit are documented. Furthermore, a Follow-up via telephone is conducted after 3 months.

Description:

The aim of a Chest Pain Unit (CPU) is to clarify unclear chest pain quickly and specifically. Present data from Germany, the USA and England prove that the organisation models of a CPU lead beside a drastic reduction of mortality also to a cost reduction as well as a shortening of the average inpatient hospital stays.

Therefore it seems reasonable to assign a minimum standard to CPUs. Although there are internationally already standards for CPUs up to complete certification programmes, it is an explicit wish of the German society for cardiology (DGK) to create an own standard which considers on the national circumstances.

The aim of the CPU register is the internal and external validation of the care quality of CPU including Benchmark reports and risk-adjusted comparisons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34470
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

All patients that are admitted to a Chest Pain Unit are included in this register.

Exclusion Criteria:

Missing informed consent (informed consent can NOT be given in the acute phase of the disease, if consciousness is limited at that time; instead the patient will be asked for his consent at a later point of time, when he is fully conscious).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chest Pain

Locations

Country	Name	City	State
Germany	Bethanien Krankenhaus	Frankfurt/Main

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	Internal and external validation of the medical care quality in the field of Chest Pain Units	including benchmark reports and risk adjusted comparisons.	hospital stay	No
Secondary	Documentation of CPU complications	including mortality, serious but non-fatal complications (e.g. stroke, heavy and moderate bleedings) as well as documentation of the medication at hospital discharge	up to 30 hours on average	No
Secondary	Documentation of long-term mortality and serious but non-fatal complications	as well as additional hospital admissions and medication	3 months after discharge	No