German Chest Pain Unit (CPU)-Register

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01197716
First received: September 7, 2010
Last updated: June 23, 2016
Last verified: June 2016
  Purpose
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.

Condition
Chest Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Deutsches CPU-Register. Unterstützt Durch Die Deutsche Gesellschaft für Kardiologie.

Resource links provided by NLM:


Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • Internal and external validation of the medical care quality in the field of Chest Pain Units [ Time Frame: hospital stay ] [ Designated as safety issue: No ]
    including benchmark reports and risk adjusted comparisons.


Secondary Outcome Measures:
  • Documentation of CPU complications [ Time Frame: up to 30 hours on average ] [ Designated as safety issue: No ]
    including mortality, serious but non-fatal complications (e.g. stroke, heavy and moderate bleedings) as well as documentation of the medication at hospital discharge

  • Documentation of long-term mortality and serious but non-fatal complications [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
    as well as additional hospital admissions and medication


Enrollment: 34470
Study Start Date: December 2008
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to a chest pain unit in a primary care clinic
Criteria

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197716

Locations
Germany
Bethanien Krankenhaus
Frankfurt/Main, Germany
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Investigators
Study Chair: Harald Darius, MD Vivantes Klinikum Neukölln
  More Information

Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01197716     History of Changes
Other Study ID Numbers: German CPU-Register 
Study First Received: September 7, 2010
Last Updated: June 23, 2016
Health Authority: Germany: Ethics Commission
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Chest Pain Unit
Myocardial infarction
Register
Admission to a Chest Pain Unit for any reason

Additional relevant MeSH terms:
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2016