NCT01644006

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

July 12, 2012

Last Update Submit

September 21, 2015

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrometelemedicineteleconsultationemergency medical service

Outcome Measures

Primary Outcomes (1)

  • Quality of prehospital care

    Analysis of the quality of the prehospital care on the basis of published guidelines for ACS / STEMI

    average 1 hour

Secondary Outcomes (5)

  • Inhospital time intervals in STEMI

    up to 12 hours

  • Rate of secondary transfer for PCI

    up to 7 days

  • Troponin-Level

    24 hours

  • Conducted procedures and medications (paramedics)

    average 1 hour

  • prehospital time intervals

    average 1 hour

Study Arms (2)

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.

Procedure: Teleconsultation

Historical Matched Pairs

NO INTERVENTION

Historical matched pairs were searched from local protocols. During this phase no teleconsultation system was existent.

Interventions

TeleconsultationPROCEDURE

Teleconsultation of an EMS physician to support the paramedics in acute coronary syndromes

Device: Teleconsultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected acute coronary syndrome
  • Verbal consent for teleconsultation obtained or patient is not able to consent due to the severity of the emergency

You may not qualify if:

  • Patient refuses consent to teleconsultation
  • No suspected acute coronary syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aachen

Aachen, 52074, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27908843DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Remote Consultation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Referral and ConsultationProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • Rolf Rossaint, Prof. Dr.

    University Hospital Aachen, Germany, Department of Anesthesiology

    STUDY CHAIR

  • Jörg C Brokmann, Dr.

    University Hospital Aachen, Germany, Emergency Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 18, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

September 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

DE(1)