G-CAR: German Cardiac Arrest Registry

Sponsor

Leipzig Heart Science gGmbH (Other)

Overall Status

Recruiting

CT.gov ID

NCT05142124

Collaborator

Leipzig Heart Institute GmbH (Other), Heart Center Leipzig - University Hospital (Other), IHF GmbH - Institut für Herzinfarktforschung (Other), Universitätsklinikum Hamburg-Eppendorf (Other), St. Antonius Hospital (Other), Klinikum Ludwigshafen (Other), University of Magdeburg (Other), Charite University, Berlin, Germany (Other), University Hospital of Cologne (Other)

400

Enrollment

Locations

29.3

Anticipated Duration (Months)

33.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Out-of-hospital Cardiac Arrest

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

400 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

German Cardiac Arrest Registry

Actual Study Start Date :

Jul 21, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

In hospital mortality [until discharge, an average of 2 weeks]

Secondary Outcome Measures

Length of ICU stay [until discharge, an average of 2 weeks]
Length of hospital stay [until discharge, an average of 2 weeks]
Mortality [Day 30]
Mortality [Month 6]
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D) [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'
Post Traumatic Stress Syndrome [Month 6]
PTSS-14
Reintegration [Month 6]
Reintegration to Normal Living Index
Hospital Anxiety and Depression Scale (HADS) [Month 6]
score 0-21; higher value show more severe depression
Mortality [Month 12]
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D) [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'
Post Traumatic Stress Syndrome (PTSS-14) [Month 12]
scor 14-98; higher value indicate more post traumatic stress
Reintegration [Month 12]
Reintegration to Normal Living Index
Hospital Anxiety and Depression Scale (HADS) [Month 12]
score 0-21; higher value indicate more severe depression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

rejection of register participation by patient or legal representative

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHARITE - Universitätsmedizin Berlin - Campus Virchow Klinikum	Berlin	Germany	13353
2	Bremer Institut für Herz- und Kreislaufforschung am Klinikum Links der Weser	Bremen	Germany	28277
3	Herzzentrum Dresden GmbH	Dresden	Germany	01307
4	Universitätsklinikum Düsseldorf - Klinik für Kardiologie, Pneumologie und Angiologie	Düsseldorf	Germany	40225
5	Elisabeth Krankenhaus Essen - Klinik für Akut- und Notfallmedizin	Essen	Germany	45138
6	Universitätsklinikum Halle (Saale)	Halle (Saale)	Germany	06120
7	Universitäres Herz- und Gefäßzentrum Hamburg	Hamburg	Germany	20246
8	Universitätsklinikum des Saarlandes	Homburg	Germany
9	Herzzentrum der Universität zu Köln	Köln	Germany	50937
10	Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology	Leipzig	Germany	04289
11	Klinikum der Stadt Ludwigshafen gGmbH	Ludwigshafen	Germany	67063
12	Herzzentrum Lübeck	Lübeck	Germany