Acute Coronary SyndromeNCT03132935
Telemedical vs. Conventional Prehospital Care in Acute Coronary Syndromes
An observational study of Acute Coronary Syndrome, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. Quality outcomes based on current guidelines were researched als well as time requirements in both groups. 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?
- Telemedical support
- Type of treatment
- Surgery or procedure
- How many people
- 221 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2014to 31 Jul 2015
- 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: Patients who called the emergency medical service and the paramedics suspect acute coronary syndrome.
Who may be able to join
- Exclusion Criteria: secondary transfers from hospital to hospital, traumatic chest pain
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality Outcomes in Acute Coronary Syndromes Between Telemedically Supported Paramedics and Conventional On-scene Physician Care
Telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. Quality outcomes based on current guidelines were researched als well as time requirements in both groups.
Read the detailed description
Telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. Quality outcomes based on current guidelines were researched als well as time requirements in both groups. All data was collected prospectively for quality management purposes and analyzed retrospectively after ethical approval by the local ethics committee.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Telemedical support
- Keywords
- Non-STEMI Acute Coronary Syndrome, ST-segment elevation myocardial infarction, Telemedicine
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedical supportProcedure or surgery
Telemedical support by a physician in a telemedicine centre
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine group | Telemedical care of acute coronary syndromes in the prehospital phase. Paramedics were supported by a physician in a tele consultation centre. Receives: Procedure: Telemedical support | |
| Control group | Conventional on-scene care of acute coronary syndromes by a physician. No telemedicine system was available during this control period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
respiratory / circulatory insufficiency, allergic reaction, cardiac arrest
Measured: prehospital phase (0.5-2 hours)
Secondary outcomes (7)
Correct use of Aspirin
Correct use of Aspirin based on current guidelines
Measured: prehospital phase (0.5-2 hours)
Correct use of unfractionated Heparin (UFH)
Correct use of UFH based on current guidelines
Measured: prehospital phase (0.5-2 hours)
Correct use of Morphine
Correct use of Morphine based on current guidelines
Measured: prehospital phase (0.5-2 hours)
Use of 12-lead-ECG
Use of 12-lead-ECG after first medical contact
Measured: prehospital phase (0.5-2 hours)
Correct transport destination
hospital with cath lab in ST-segment elevation myocardial infarction or high-risk Non-STEMI-ACS
Measured: prehospital phase (0.5-2 hours)
Correct use of oxygen
Correct use of Morphine based on current guidelines
Measured: prehospital phase (0.5-2 hours)
Correct use of Glyceroltrinitrate
Correct use of Glyceroltrinitrate based on current guidelines
Measured: prehospital phase (0.5-2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Jan 2014
- Primary completion31 Jul 2015
- Study completion31 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132935
- Sponsor's protocol ID
- TEMS-ACS
- Status last verified
- Apr 2017
- First submitted
- 24 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Outcomes in Acute Coronary Syndromes Between Telemedically Supported Paramedics and Conventional On-scene Physician Care
- ClinicalTrials.gov ID
- NCT03132935
- Acronym / sponsor ID
- TEMS-ACS
- Conditions
- Acute Coronary Syndrome
- Keywords
- Non-STEMI Acute Coronary Syndrome, ST-segment elevation myocardial infarction, Telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 28 Apr 2017 (actual)
- 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.
Telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. Quality outcomes based on current guidelines were researched als well as time requirements in both groups.
Detailed description
Telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. Quality outcomes based on current guidelines were researched als well as time requirements in both groups. All data was collected prospectively for quality management purposes and analyzed retrospectively after ethical approval by the local ethics committee.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine group | – | Procedure: Telemedical supportTelemedical care of acute coronary syndromes in the prehospital phase. Paramedics were supported by a physician in a tele consultation centre. |
| Control group | – | –Conventional on-scene care of acute coronary syndromes by a physician. No telemedicine system was available during this control period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who called the emergency medical service and the paramedics suspect acute coronary syndrome.
Key inclusion criteria (2 listed)
- Exclusion Criteria: secondary transfers from hospital to hospital, traumatic chest pain
- -
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedical supportTelemedical support by a physician in a telemedicine centre | Procedure or surgery | Telemedicine group |
Primary outcome
Adverse events
Time frame: prehospital phase (0.5-2 hours)
respiratory / circulatory insufficiency, allergic reaction, cardiac arrest
7 secondary outcomes
Correct use of Aspirin
Time frame: prehospital phase (0.5-2 hours)
Correct use of unfractionated Heparin (UFH)
Time frame: prehospital phase (0.5-2 hours)
Correct use of Morphine
Time frame: prehospital phase (0.5-2 hours)
Use of 12-lead-ECG
Time frame: prehospital phase (0.5-2 hours)
Correct transport destination
Time frame: prehospital phase (0.5-2 hours)
Correct use of oxygen
Time frame: prehospital phase (0.5-2 hours)
Correct use of Glyceroltrinitrate
Time frame: prehospital phase (0.5-2 hours)
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 28 Apr 2017.
- Individual participant dataSharing planned: No
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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 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 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 28 Apr 2017. 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?
Adverse events (time frame: prehospital phase (0.5-2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2017.