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CompletedNCT01486589PREDICT-ERUpdated Feb 6, 2014

Cardiac Autonomic Function For Risk Stratification in the Emergency Room

An observational study in Autonomic Nervous System Activity, sponsored by Thebiosignals.com. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-06.

Sponsored by Thebiosignals.com · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,521
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to test the hypothesis that impaired cardiac autonomic function predicts adverse outcome in unselected patients presenting in the emergency ward.

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Conditions studied

  • Autonomic Nervous System Activity

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Keywords

  • emergency care
  • cardiac autonomic function
  • deceleration capacity
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 6,521 is above the median of 353 across 714 observational studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Thebiosignals.com is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive patients presenting at the emergency department of the University Hospital of Tübingen

Eligibility criteria

Inclusion Criteria:

  • presenting at the emergency department of the University Hospital of Tübingen
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,521 participants (actual)
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What researchers measure

Primary outcomes

  1. In-hospital mortality

    Time frame: 10 days

Secondary outcomes

  1. Cardiac mortality

    Time frame: 10 days

  2. transfer to intensive care unit

    Time frame: 10 days

  3. hospital discharge

    Time frame: 48 hours

  4. duration of hospital stay

    Time frame: within 30 days

  5. costs of health care

    Time frame: 30 days

  6. 180 day mortality

    Time frame: 180 days

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Study locations

1 site
  • Medizinische Universitätsklinik Tübingen
    Tübingen, Baden-Württemberg 72076, Germany
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References and documents

Publications

  • Eick C, Duckheim M, Groga-Bada P, Klumpp N, Mannes S, Zuern CS, Gawaz M, Rizas KD, Bauer A. Point-of-care testing of cardiac autonomic function for risk assessment in patients with suspected acute coronary syndromes. Clin Res Cardiol. 2017 Sep;106(9):686-694. doi: 10.1007/s00392-017-1104-3. Epub 2017 Mar 22. PubMed 28331988 ↗
  • Eick C, Rizas KD, Meyer-Zurn CS, Groga-Bada P, Hamm W, Kreth F, Overkamp D, Weyrich P, Gawaz M, Bauer A. Autonomic nervous system activity as risk predictor in the medical emergency department: a prospective cohort study. Crit Care Med. 2015 May;43(5):1079-86. doi: 10.1097/CCM.0000000000000922. PubMed 25738854 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01486589
Lead sponsor
Thebiosignals.com
Responsible party
Axel Bauer (Prof. Dr. Axel Bauer, University Hospital Tuebingen) — Principal investigator
First posted
Dec 6, 2011
Start date
Oct 2010
Primary completion
Jun 2013
Last update
Feb 6, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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