NCT03132935

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

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

Study Start

First participant enrolled

January 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

April 24, 2017

Last Update Submit

April 24, 2017

Conditions

Acute Coronary Syndrome

Keywords

Non-STEMI Acute Coronary SyndromeST-segment elevation myocardial infarctionTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    respiratory / circulatory insufficiency, allergic reaction, cardiac arrest

    prehospital phase (0.5-2 hours)

Secondary Outcomes (7)

  • Correct use of Aspirin

    prehospital phase (0.5-2 hours)

  • Correct use of unfractionated Heparin (UFH)

    prehospital phase (0.5-2 hours)

  • Correct use of Morphine

    prehospital phase (0.5-2 hours)

  • Use of 12-lead-ECG

    prehospital phase (0.5-2 hours)

  • Correct transport destination

    prehospital phase (0.5-2 hours)

  • +2 more secondary outcomes

Study Arms (2)

Telemedicine group

Telemedical care of acute coronary syndromes in the prehospital phase. Paramedics were supported by a physician in a tele consultation centre.

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.

Interventions

Telemedical supportPROCEDURE

Telemedical support by a physician in a telemedicine centre

Telemedicine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who called the emergency medical service and the paramedics suspect acute coronary syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aachen

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Acute Coronary SyndromeST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2017

First Posted

April 28, 2017

Study Start

January 1, 2014

Primary Completion

July 31, 2015

Study Completion

July 31, 2015

Last Updated

April 28, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)