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Chest Pain Unit II Register

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ClinicalTrials.gov Identifier: NCT03091829
Recruitment Status : Active, not recruiting
First Posted : March 27, 2017
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung

Brief 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.

Condition or disease
Chest Pain

Detailed 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


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Study Type : Observational [Patient Registry]
Actual Enrollment : 4829 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Chest Pain Unit II Register - CPU II Register
Actual Study Start Date : January 2016
Actual Primary Completion Date : April 30, 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain




Primary Outcome Measures :
  1. Fulfillment of DGK criteria [ Time Frame: 12 months ]
    Quality assurance: Fulfillment of the recertification criteria of the german society for cardiology

  2. Clinical progress after CPU [ Time Frame: 12 months ]
    Scientific protocol: Documentation of the clinical progress after CPU



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Basic register:

All patients who are admitted to a CPU.

Scientific Protocol:

All patients who are admitted to a CPU and have their consent to participate in a follow-up (in patients with leading cardiac diagnosis).

Criteria

Inclusion Criteria:

  • CPU patient
  • > 18 years
  • Written consent of the patient

Exclusion Criteria:

  • Denied consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091829


Locations
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Germany
Städtisches Klinikum Neuperlach
Munchen, Bayern, Germany, 81737
Klinikum der Johannes-Gutenberg-Universität, 2. Med. Klinik
Mainz, RLP, Germany, 55131
Klinikum Links der Weser Bremen
Bremen, Germany, 28277
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung

Additional Information:

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Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT03091829     History of Changes
Other Study ID Numbers: CPU II Register
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms