Clinical trial NCT05142124: German Cardiac Arrest Registry
Official title: German Cardiac Arrest Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Out-of-hospital Cardiac Arrest
Keywords: Out-of-hospital Cardiac Arrest
OHCA
resuscitation
cardiac arrest center
acute care medicine
intensive care
post-resuscitation care
Lead sponsor: Leipzig Heart Science gGmbH
Sponsor class: OTHER
Collaborators: name: Helios Health Institute GmbH
name: Heart Center Leipzig - University Hospital
name: IHF GmbH - Institut für Herzinfarktforschung
name: Universitätsklinikum Hamburg-Eppendorf
name: St. Antonius Hospital
name: Klinikum Ludwigshafen
name: University of Magdeburg
name: Charite University, Berlin, Germany
name: University Hospital of Cologne
First posted: 2021-12-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with out-of-hospital cardiac arrest with assumed cardiovacular cause

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* rejection of register participation by patient or legal representative

Primary outcomes:
measure: In hospital mortality
timeFrame: until discharge, an average of 2 weeks
Secondary outcomes:
measure: Length of ICU stay
timeFrame: until discharge, an average of 2 weeks
measure: Length of hospital stay
timeFrame: until discharge, an average of 2 weeks
measure: Mortality
timeFrame: Day 30
measure: Mortality
timeFrame: Month 6
measure: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D)
timeFrame: Month 6
measure: Post Traumatic Stress Syndrome
timeFrame: Month 6
measure: Reintegration
timeFrame: Month 6
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Month 6
measure: Mini Montreal Cognitive Assessment (MoCA)
timeFrame: Month 6
measure: Mini Montreal Cognitive Assessment (MoCA)
timeFrame: Month 12
measure: Mortality
timeFrame: Month 12
measure: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D)
timeFrame: Month 12
measure: Post Traumatic Stress Syndrome (PTSS-14)
timeFrame: Month 12
measure: Reintegration
timeFrame: Month 12
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Month 12
Other outcomes:
Locations:
city: Bad Friedrichshall
country: Germany
facility: SLK-Kliniken Heilbronn - Klinikum am Plattenwald
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Deutsches Herzzentrum Berlin
city: Berlin
country: Germany
facility: CHARITE - Universitätsmedizin Berlin - Campus Virchow Klinikum
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Bremen
country: Germany
facility: Bremer Institut für Herz- und Kreislaufforschung am Klinikum Links der Weser
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf - Klinik für Kardiologie, Pneumologie und Angiologie
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen - Klinik für Akut- und Notfallmedizin
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Höchst
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum Hamburg
city: Hamburg
country: Germany
facility: Asklepios Klinik St- Georg Hamburg
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Köln
country: Germany
facility: Herzzentrum der Universität zu Köln
city: Leipzig
country: Germany
facility: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen gGmbH
city: Lübeck
country: Germany
facility: Herzzentrum Lübeck
city: München
country: Germany
facility: Klinikum der Universität München
city: Neustadt
country: Germany
facility: Marienhaus Klinikum Hetzelstift
city: Singen
country: Germany
facility: Hegau-Bodensee Klinikum
city: Singen
country: Germany
facility: Hegau-Bodensee-Klinikum Singen
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum VS
city: Wiesbaden
country: Germany
facility: Dr. Horst Schmidt Kliniken
Study officials:
affiliation: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
name: Janine Pöss, Dr.
role: STUDY_CHAIR
References:
citation: Poss J, Sinning C, Schreiner I, Apfelbacher C, Drewitz KP, Hosler N, Schneider S, Pieske B, Bottiger BW, Ewen S, Wienbergen H, Kelm M, Bock D, Graf T, Adler C, Dutzmann J, Knie W, Orban M, Zeymer U, Michels G, Thiele H; G-CAR Investigators. German Cardiac Arrest Registry: rationale and design of G-CAR. Clin Res Cardiol. 2023 Apr;112(4):455-463. doi: 10.1007/s00392-022-02044-9. Epub 2022 Jun 21.