German Cardiac Arrest Registry

Out-of-hospital Cardiac Arrest Clinical Trial

— G-CAR  

Official title:

German Cardiac Arrest Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142124
• Other study ID #: 2020-0396
• Status: Recruiting
• Start date: July 21, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Leipzig Heart Science gGmbH
• Contact: Janine Pöss, Dr.
• Phone: +49 341 865
• Email: janine.poess[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with out-of-hospital cardiac arrest with assumed cardiovascular cause

Exclusion Criteria:

• rejection of register participation by patient or legal representative

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Locations

Country	Name	City	State
Germany	CHARITE - Universitätsmedizin Berlin - Campus Virchow Klinikum	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Bremer Institut für Herz- und Kreislaufforschung am Klinikum Links der Weser	Bremen
Germany	Herzzentrum Dresden GmbH	Dresden
Germany	Universitätsklinikum Düsseldorf - Klinik für Kardiologie, Pneumologie und Angiologie	Düsseldorf
Germany	Elisabeth Krankenhaus Essen - Klinik für Akut- und Notfallmedizin	Essen
Germany	Klinikum Frankfurt Höchst	Frankfurt
Germany	Universitätsklinikum Halle (Saale)	Halle (Saale)
Germany	Asklepios Klinik St- Georg Hamburg	Hamburg
Germany	Universitäres Herz- und Gefäßzentrum Hamburg	Hamburg
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Herzzentrum der Universität zu Köln	Köln
Germany	Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology	Leipzig
Germany	Herzzentrum Lübeck	Lübeck
Germany	Klinikum der Stadt Ludwigshafen gGmbH	Ludwigshafen
Germany	Klinikum der Universität München	München
Germany	Marienhaus Klinikum Hetzelstift	Neustadt
Germany	Dr. Horst Schmidt Kliniken	Wiesbaden

Sponsors (10)

Lead Sponsor	Collaborator
Leipzig Heart Science gGmbH	Charite University, Berlin, Germany, Heart Center Leipzig - University Hospital, Helios Health Institute GmbH, IHF GmbH - Institut für Herzinfarktforschung, Klinikum Ludwigshafen, St. Antonius Hospital, Universitätsklinikum Hamburg-Eppendorf, University Hospital of Cologne, University of Magdeburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In hospital mortality		until discharge, an average of 2 weeks
Secondary	Length of ICU stay		until discharge, an average of 2 weeks
Secondary	Length of hospital stay		until discharge, an average of 2 weeks
Secondary	Mortality		Day 30
Secondary	Mortality		Month 6
Secondary	European Quality of Life 5 Dimensions 5 Level Version (EQ-5D)	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
Secondary	Post Traumatic Stress Syndrome	PTSS-14	Month 6
Secondary	Reintegration	Reintegration to Normal Living Index	Month 6
Secondary	Hospital Anxiety and Depression Scale (HADS)	score 0-21; higher value show more severe depression	Month 6
Secondary	Mini Montreal Cognitive Assessment (MoCA)	score 0-15; 11 or higher is normal, 10 or less indicate cognitive dysfunction	Month 6
Secondary	Mini Montreal Cognitive Assessment (MoCA)	score 0-15; 11 or higher is normal, 10 or less indicate cognitive dysfunction	Month 12
Secondary	Mortality		Month 12
Secondary	European Quality of Life 5 Dimensions 5 Level Version (EQ-5D)	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
Secondary	Post Traumatic Stress Syndrome (PTSS-14)	scor 14-98; higher value indicate more post traumatic stress	Month 12
Secondary	Reintegration	Reintegration to Normal Living Index	Month 12
Secondary	Hospital Anxiety and Depression Scale (HADS)	score 0-21; higher value indicate more severe depression	Month 12