Autonomic Nervous System ActivityPREDICT-ERNCT01486589
Cardiac Autonomic Function For Risk Stratification in the Emergency Room
An observational study of Autonomic Nervous System Activity, run by Thebiosignals.com at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autonomic Nervous System Activity
- How many people
- 6,521 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients presenting at the emergency department of the University Hospital of Tübingen
Who may be able to join
- presenting at the emergency department of the University Hospital of Tübingen
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Universitätsklinik Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Risk Stratification in the Emergency Room by Cardiac Autonomic Function
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.
- Conditions
- Autonomic Nervous System Activity
- Keywords
- emergency care, cardiac autonomic function, deceleration capacity
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: 10 days
Secondary outcomes (6)
Cardiac mortality
Measured: 10 days
transfer to intensive care unit
Measured: 10 days
hospital discharge
Measured: 48 hours
duration of hospital stay
Measured: within 30 days
costs of health care
Measured: 30 days
180 day mortality
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startOct 2010
- Primary completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autonomic Nervous System ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thebiosignals.com
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Bauer, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486589
- Sponsor's protocol ID
- 577/2011BO1
- Acronym
- PREDICT-ER
- Status last verified
- Feb 2014
- First submitted
- 2 Dec 2011
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
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 28331988Eick 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification in the Emergency Room by Cardiac Autonomic Function
- ClinicalTrials.gov ID
- NCT01486589
- Acronym / sponsor ID
- PREDICT-ER / 577/2011BO1
- Conditions
- Autonomic Nervous System Activity
- Keywords
- emergency care, cardiac autonomic function, deceleration capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,521 participants (actual)
- Lead sponsor
- Thebiosignals.comUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2013 (actual)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients presenting at the emergency department of the University Hospital of Tübingen
Key inclusion criteria (1 listed)
- presenting at the emergency department of the University Hospital of Tübingen
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality
Time frame: 10 days
6 secondary outcomes
Cardiac mortality
Time frame: 10 days
transfer to intensive care unit
Time frame: 10 days
hospital discharge
Time frame: 48 hours
duration of hospital stay
Time frame: within 30 days
costs of health care
Time frame: 30 days
180 day mortality
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Derived from this study: PubMed 28331988Eick 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.
- Derived from this study: PubMed 25738854Eick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Nervous System Activity, run by Thebiosignals.com at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01486589, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.