- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03132935
Telemedical vs. Conventional Prehospital Care in Acute Coronary Syndromes
April 24, 2017 updated by: RWTH Aachen University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
221
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aachen, Germany, 52074
- University Hospital Aachen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who called the emergency medical service and the paramedics suspect acute coronary syndrome.
Description
Inclusion Criteria: symptoms of acute coronary syndrome -
Exclusion Criteria: secondary transfers from hospital to hospital, traumatic chest pain
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Telemedicine group
Telemedical care of acute coronary syndromes in the prehospital phase.
Paramedics were supported by a physician in a tele consultation centre.
|
Telemedical support by a physician in a telemedicine centre
|
Control group
Conventional on-scene care of acute coronary syndromes by a physician.
No telemedicine system was available during this control period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: prehospital phase (0.5-2 hours)
|
respiratory / circulatory insufficiency, allergic reaction, cardiac arrest
|
prehospital phase (0.5-2 hours)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correct use of Aspirin
Time Frame: prehospital phase (0.5-2 hours)
|
Correct use of Aspirin based on current guidelines
|
prehospital phase (0.5-2 hours)
|
Correct use of unfractionated Heparin (UFH)
Time Frame: prehospital phase (0.5-2 hours)
|
Correct use of UFH based on current guidelines
|
prehospital phase (0.5-2 hours)
|
Correct use of Morphine
Time Frame: prehospital phase (0.5-2 hours)
|
Correct use of Morphine based on current guidelines
|
prehospital phase (0.5-2 hours)
|
Use of 12-lead-ECG
Time Frame: prehospital phase (0.5-2 hours)
|
Use of 12-lead-ECG after first medical contact
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prehospital phase (0.5-2 hours)
|
Correct transport destination
Time Frame: prehospital phase (0.5-2 hours)
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hospital with cath lab in ST-segment elevation myocardial infarction or high-risk Non-STEMI-ACS
|
prehospital phase (0.5-2 hours)
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Correct use of oxygen
Time Frame: prehospital phase (0.5-2 hours)
|
Correct use of Morphine based on current guidelines
|
prehospital phase (0.5-2 hours)
|
Correct use of Glyceroltrinitrate
Time Frame: prehospital phase (0.5-2 hours)
|
Correct use of Glyceroltrinitrate based on current guidelines
|
prehospital phase (0.5-2 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
July 31, 2015
Study Completion (Actual)
July 31, 2015
Study Registration Dates
First Submitted
April 24, 2017
First Submitted That Met QC Criteria
April 24, 2017
First Posted (Actual)
April 28, 2017
Study Record Updates
Last Update Posted (Actual)
April 28, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEMS-ACS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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