Chest Pain Unit II Register

Chest Pain Unit II Register - CPU II Register

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.

Study Overview

• Status: Completed
• Conditions: 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

• Study Type: Observational
• Enrollment (Actual): 4829

Contacts and Locations

Study Locations

• Germany
  • Bremen, Germany, 28277
    • Klinikum Links der Weser Bremen
  • Bayern
    • Munchen, Bayern, Germany, 81737
      • Städtisches Klinikum Neuperlach
  • RLP
    • Mainz, RLP, Germany, 55131
      • Klinikum der Johannes-Gutenberg-Universität, 2. Med. Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Denied consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stiftung Institut fuer Herzinfarktforschung

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: CPU II Register

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No