Acute Coronary SyndromeNCT01644006
Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome
A study testing Teleconsultation in people with Acute Coronary Syndrome, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of the study is to investigate the quality of prehospital emergency care in acute coronary syndromes, when paramedics are supported telemedically by an EMS physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Teleconsultation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Sep 2015
- Phase
- Interventional
- 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
Who may be able to join
- Suspected acute coronary syndrome
- Verbal consent for teleconsultation obtained or patient is not able to consent due to the severity of the emergency
Who cannot join
- Patient refuses consent to teleconsultation
- No suspected acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndromes
The aim of the study is to investigate the quality of prehospital emergency care in acute coronary syndromes, when paramedics are supported telemedically by an EMS physician.
Read the detailed description
Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of suspected acute coronary syndrome (including STEMI), the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. Also 12-lead-ECGs can transmitted to the tele-EMS physician. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, ECG diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene.
The quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Teleconsultation
- Keywords
- acute coronary syndrome, telemedicine, teleconsultation, emergency medical service
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleconsultationProcedure or surgery
Teleconsultation of an EMS physician to support the paramedics in acute coronary syndromes
| Study group | Role | What they receive |
|---|---|---|
| Device: Teleconsultation | Experimental | In cases of suspected acute coronary syndrome (including STEMI), if patients give informed consent the paramedics can use this system to contact a so called "tele-EMS physician" with audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. Also 12-lead-ECGs can be transmitted to the tele-EMS physician. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, ECG diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene.
The quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS. Receives: Procedure: Teleconsultation |
| Historical Matched Pairs | No intervention | Historical matched pairs were searched from local protocols. During this phase no teleconsultation system was existent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of prehospital care
Analysis of the quality of the prehospital care on the basis of published guidelines for ACS / STEMI
Measured: average 1 hour
Secondary outcomes (5)
Inhospital time intervals in STEMI
contact to balloon time, arrival to balloon time
Measured: up to 12 hours
Rate of secondary transfer for PCI
Rate of secondary transfer to a different facility for PCI
Measured: up to 7 days
Troponin-Level
Severity of infarction measured with level of Troponin
Measured: 24 hours
Conducted procedures and medications (paramedics)
Amount of guidelines based procedures and medications carried out by paramedics prior to the contact with a physician.
Measured: average 1 hour
prehospital time intervals
on-scene time, contact (EMS) to hospital arrival time, transport time
Measured: average 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolf Rossaint, Prof. Dr., Study chair, University Hospital Aachen, Germany, Department of AnesthesiologyJörg C Brokmann, Dr., Principal investigator, University Hospital Aachen, Germany, Emergency Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644006
- Sponsor's protocol ID
- 005-1003-0034-1
- Other IDs
- PtJ-Az.: z0909im002b
- Status last verified
- Sep 2015
- First submitted
- 12 Jul 2012
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Brokmann JC, Conrad C, Rossaint R, Bergrath S, Beckers SK, Tamm M, Czaplik M, Hirsch F. Treatment of Acute Coronary Syndrome by Telemedically Supported Paramedics Compared With Physician-Based Treatment: A Prospective, Interventional, Multicenter Trial. J Med Internet Res. 2016 Dec 1;18(12):e314. doi: 10.2196/jmir.6358.
PubMed 27908843
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT01644006
- Acronym / sponsor ID
- 005-1003-0034-1
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, telemedicine, teleconsultation, emergency medical service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Jul 2012 (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 investigate the quality of prehospital emergency care in acute coronary syndromes, when paramedics are supported telemedically by an EMS physician.
Detailed description
Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of suspected acute coronary syndrome (including STEMI), the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. Also 12-lead-ECGs can transmitted to the tele-EMS physician. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, ECG diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene.
The quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device: Teleconsultation | Experimental | Procedure: TeleconsultationIn cases of suspected acute coronary syndrome (including STEMI), if patients give informed consent the paramedics can use this system to contact a so called "tele-EMS physician" with audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. Also 12-lead-ECGs can be transmitted to the tele-EMS physician. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, ECG diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS. |
| Historical Matched Pairs | No intervention | –Historical matched pairs were searched from local protocols. During this phase no teleconsultation system was existent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected acute coronary syndrome
- Verbal consent for teleconsultation obtained or patient is not able to consent due to the severity of the emergency
Key exclusion criteria (2 listed)
- Patient refuses consent to teleconsultation
- No suspected acute coronary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleconsultationTeleconsultation of an EMS physician to support the paramedics in acute coronary syndromes | Procedure or surgery | Device: Teleconsultation |
Primary outcome
Quality of prehospital care
Time frame: average 1 hour
Analysis of the quality of the prehospital care on the basis of published guidelines for ACS / STEMI
5 secondary outcomes
Inhospital time intervals in STEMI
Time frame: up to 12 hours
Rate of secondary transfer for PCI
Time frame: up to 7 days
Troponin-Level
Time frame: 24 hours
Conducted procedures and medications (paramedics)
Time frame: average 1 hour
prehospital time intervals
Time frame: average 1 hour
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 22 Sep 2015.
- Derived from this study: PubMed 27908843Brokmann JC, Conrad C, Rossaint R, Bergrath S, Beckers SK, Tamm M, Czaplik M, Hirsch F. Treatment of Acute Coronary Syndrome by Telemedically Supported Paramedics Compared With Physician-Based Treatment: A Prospective, Interventional, Multicenter Trial. J Med Internet Res. 2016 Dec 1;18(12):e314. doi: 10.2196/jmir.6358.
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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.
Rolf Rossaint, Prof. Dr. study chair
University Hospital Aachen, Germany, Department of Anesthesiology
Jörg C Brokmann, Dr. principal investigator
University Hospital Aachen, Germany, Emergency Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconsultation in people with Acute Coronary Syndrome, run by RWTH Aachen University 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 2 inclusion and 2 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 22 Sep 2015. 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?
Quality of prehospital care (time frame: average 1 hour). 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 NCT01644006, which also lists 1 linked publication.
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 22 Sep 2015.