- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05142124
German Cardiac Arrest Registry (G-CAR)
March 6, 2024 updated by: Leipzig Heart Science gGmbH
In Germany, 70.000 to 100.000 patients suffer from out-of-hospital cardiac arrest (OHCA) every year.
More than half of these are due to cardiac causes.
Despite the medical progress over the last decades, rates of survival with good neurological outcome remain low.
For many below-mentioned issues, no adequate evidence from randomized trials is available.
Therefore, a systematic and standardized recording of the pre-clinical, clinical and post-clinical treatment course and of the clinical outcomes of OHCA patients is essential to improve patient care.
Aim of the German Cardiac Arrest Registry (G-CAR) is to achieve a better understanding of the disease entity, leading to an optimized treatment of OHCA patients.
The recorded data include information on demographic and psychosocial aspects, course of the disease, clinical, laboratory and other examinations as well as treatment modalities in patients with OHCA due to a cardiac cause.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Janine Pöss, Dr.
- Phone Number: 1428 +49 341 865
- Email: janine.poess@medizin.uni-leipzig.de
Study Contact Backup
- Name: Holger Thiele, Prof.
- Phone Number: 1428 +49 341 865
- Email: holger.thiele@medizin.uni-leipzig.de
Study Locations
-
-
-
Berlin, Germany, 13353
- Recruiting
- CHARITE - Universitätsmedizin Berlin - Campus Virchow Klinikum
-
Contact:
- Bastian Maroski, Dr.
-
Bonn, Germany
- Recruiting
- Universitätsklinikum Bonn
-
Contact:
- Sebastian Zimmer, Prof. Dr.
-
Contact:
- Philip R Goody, Dr.
-
Bremen, Germany, 28277
- Recruiting
- Bremer Institut für Herz- und Kreislaufforschung am Klinikum Links der Weser
-
Contact:
- Harm Wienbergen, Prof.
-
Contact:
- Jelena Köster, Dr.
-
Dresden, Germany, 01307
- Recruiting
- Herzzentrum Dresden GmbH
-
Contact:
- Julia Fischer
-
Düsseldorf, Germany, 40225
- Recruiting
- Universitätsklinikum Düsseldorf - Klinik für Kardiologie, Pneumologie und Angiologie
-
Contact:
- Malte Kelm, Prof.
-
Contact:
- Ralf Westenfeld, PD Dr.
-
Essen, Germany, 45138
- Recruiting
- Elisabeth Krankenhaus Essen - Klinik für Akut- und Notfallmedizin
-
Contact:
- Ingo Voigt, Dr.
-
Frankfurt, Germany, 65929
- Recruiting
- Klinikum Frankfurt Höchst
-
Contact:
- Daniel Bock, Dr.
-
Halle (Saale), Germany, 06120
- Recruiting
- Universitatsklinikum Halle (Saale)
-
Contact:
- Daniel Sedding, Prof. Dr.
-
Contact:
- Jochen Dutzmann, Dr.
-
Hamburg, Germany, 20246
- Recruiting
- Universitäres Herz- und Gefäßzentrum Hamburg
-
Contact:
- Christoph Sinning, PD Dr.
-
Hamburg, Germany
- Recruiting
- Asklepios Klinik St- Georg Hamburg
-
Contact:
- Eike P Tigges, Dr.
-
Homburg, Germany
- Recruiting
- Universitätsklinikum des Saarlandes
-
Contact:
- Sebastian Ewen, PD Dr.
-
Köln, Germany, 50937
- Recruiting
- Herzzentrum der Universität zu Köln
-
Contact:
- Christoph Adler, PD Dr.
-
Leipzig, Germany, 04289
- Recruiting
- Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
-
Contact:
- Janine Pöss, Dr.
- Phone Number: 1428 +49 341 865
- Email: janine.poess@medizin.uni-leipzig.de
-
Contact:
- Holger Thiele, Prof.
- Email: holger.thiele@medizin.uni-leipzig.de
-
Ludwigshafen, Germany, 67063
- Recruiting
- Klinikum der Stadt Ludwigshafen gGmbH
-
Contact:
- Uwe Zeymer, Prof.
-
Lübeck, Germany
- Recruiting
- Herzzentrum Lübeck
-
Contact:
- Tobias Graf, Dr.
-
Contact:
- Georg Fürnau, PD Dr.
-
München, Germany, 81377
- Recruiting
- Klinikum der Universität München
-
Contact:
- Martin Orban, Prof. Dr.
-
Neustadt, Germany, 67434
- Recruiting
- Marienhaus Klinikum Hetzelstift
-
Contact:
- Patrick Swojanowsky, Dr.
-
Wiesbaden, Germany
- Recruiting
- Dr. Horst Schmidt Kliniken
-
Contact:
- Markus Ferrari, Prof. Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
patients with out-of-hospital cardiac arrest with assumed cardiovacular cause
Description
Inclusion Criteria:
- patients with out-of-hospital cardiac arrest with assumed cardiovascular cause
Exclusion Criteria:
- rejection of register participation by patient or legal representative
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In hospital mortality
Time Frame: until discharge, an average of 2 weeks
|
until discharge, an average of 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: Day 30
|
Day 30
|
|
Mortality
Time Frame: Month 6
|
Month 6
|
|
Length of ICU stay
Time Frame: until discharge, an average of 2 weeks
|
until discharge, an average of 2 weeks
|
|
Length of hospital stay
Time Frame: until discharge, an average of 2 weeks
|
until discharge, an average of 2 weeks
|
|
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D)
Time Frame: Month 6
|
five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to'
|
Month 6
|
Post Traumatic Stress Syndrome
Time Frame: Month 6
|
PTSS-14
|
Month 6
|
Reintegration
Time Frame: Month 6
|
Reintegration to Normal Living Index
|
Month 6
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Month 6
|
score 0-21; higher value show more severe depression
|
Month 6
|
Mortality
Time Frame: Month 12
|
Month 12
|
|
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D)
Time Frame: Month 12
|
five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to'
|
Month 12
|
Post Traumatic Stress Syndrome (PTSS-14)
Time Frame: Month 12
|
scor 14-98; higher value indicate more post traumatic stress
|
Month 12
|
Reintegration
Time Frame: Month 12
|
Reintegration to Normal Living Index
|
Month 12
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Month 12
|
score 0-21; higher value indicate more severe depression
|
Month 12
|
Mini Montreal Cognitive Assessment (MoCA)
Time Frame: Month 6
|
score 0-15; 11 or higher is normal, 10 or less indicate cognitive dysfunction
|
Month 6
|
Mini Montreal Cognitive Assessment (MoCA)
Time Frame: Month 12
|
score 0-15; 11 or higher is normal, 10 or less indicate cognitive dysfunction
|
Month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Janine Pöss, Dr., Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 21, 2021
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
November 8, 2021
First Submitted That Met QC Criteria
November 18, 2021
First Posted (Actual)
December 2, 2021
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0396
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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