Pre-Hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-Held Device
Pre-hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-held Device: The TIME Multicenter Study
1 other identifier
observational
527
1 country
7
Brief Summary
Aim: To determine the impact of wireless transmission of prehospital ECGs to a hand-held computer on time to treatment and myocardial salvage in acute MI patients. Background: The TIME-1 investigators documented a 27% (109 to 80 minutes) reduction of time from EMT arrival at the scene to successful primary PCI implementing pre-hospital ECG transmission to the ED. ECG transmission directly to a physician's cellular phone/PDA through a wireless modem has only recently become an option. The recently completed TIME-NorthEast (NE) study tested the Welch Allyn version of this system and the results show a reduction in time to reperfusion for acute MI patients by 66 minutes (116 to 50). Methods: This study will involve approximately 20 sites around the country. The study will be divided into two phases: a consecutive control data collection phase (Phase I) and an intervention with concurrent control phase (Phase II). Phase II will begin after installation of Welch Allyn ECG transmission equipment. The primary end-point will be time to reperfusion and secondary end-points will include myocardial salvage, aborted infarction and hospital mortality. ECG measurements will be made at a central ECG core lab by a blinded investigator. Data Analysis: Patient characteristics for the three periods were compared with the chi-square statistic for categorical variables and one-way analysis of variance for age. The Wilcoxon rank-sum statistic was used to compare time-to-reperfusion in the pre-study and study periods as well as in the Group 1 post-study period. Comparisons were performed separately for EMS and self-transport groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2003
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 12, 2008
CompletedFirst Posted
Study publicly available on registry
May 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFebruary 23, 2012
February 1, 2012
5.3 years
May 12, 2008
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Door to intervention time - time from emergency department door time until intervention.
time from emergency department door time until intervention.
Secondary Outcomes (4)
Salvaged myocardial tissue - pre-hospital ECGs will be read using the Aldrich final MI size prediction to calculate the size of infarct that would be expected to result without reperfusion treatment.
pre hospital ECG - discharge ECG
Aborted infarction-defined as combined ECG and cardiac biomarkers criteria:1.subsiding of ST deviation greater than or equal to 50% within 2 hours after reperfusion treatment. 2.rise in cardiac enzymes less than or equal to 2 times upper value of normal.
2 hours after reperfusion treatment
Hospital mortality - whether the patient was discharged alive.
discharge
No infarct related artery at time of heart catheterization.
catheterization
Study Arms (3)
Pre-study Period (Group 1 and Group 2).
The TIME-MC study was conducted from June 2003 to June 2008 at NEMC (Figure 1) and from May 2005 to September 2008 at the six larger medical centers (Figure 2). Two groups were studied. Group 1 included patients at NEMC and Group 2 included patients at the other six medical sites. The study was divided into three periods: Pre-study period (Group 1 and Group 2). No PH-ECG transmission system was available.
Study Period (Group 1 and Group 2)
Study period (Group 1 and Group 2). PH-ECG transmission to a cardiologist's hand-held device was attempted through pre-assigned EMS ambulances equipped with a wireless ECG transmission device in addition to a STEMI code system. In Group 1, this referred to the pilot study at NEMC from June 2003 to May 2005.
Post-study period (Group 1)
Post-study period (Group 1). PH-ECG transmission and a STEMI code system implemented after the pilot study period.
Interventions
All EMS transported patients age 18 or over who have their ECG attempted to be wirelessly transmitted and with the intention to treat with coronary reperfusion therapy (PCI or thrombolytics)based on their initial presentation.
Eligibility Criteria
EMS transported patients age 18 or over who have their ECG attempted to be wirelessly transmitted and with the intention to treat with coronary reperfusion therapy (PCI or thrombolytics) based on their initial presentation All self transported and EMS transported patients age 18 or over with the intention to undergo reperfusion therapy (PCI or thrombolytics)based on their initial presentation who do not qualify for the intervention group.
You may qualify if:
- All patients with a diagnosis of acute STEMI defined as 1 mm ST segment elevation in two spatially contiguous leads were included. There were two major subgroups: emergency medical services (EMS) and self-transport patients. Self-transport patients, who did not have PH-ECG transmission, served as a comparison group.
You may not qualify if:
- Less than age 18
- No intent to undergo reperfusion therapy (PCI or thrombolytics)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Welch Allynlead
- Duke Universitycollaborator
Study Sites (7)
Salinas Valley Memorial Healthcare System
Salinas, California, 93901, United States
Shands @ AGH
Gainesville, Florida, 32605, United States
South Miami Heart Center
Miami, Florida, 33143, United States
Durham Regional Hospital
Durham, North Carolina, 27704, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
University of Pittsburgh Medical Center - Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Adams G, Abusaid G, Lee B, Maynard C, Campbell P, Wagner G, Barbagelata A. From theory to practice: implementation of pre-hospital electrocardiogram transmission in ST-elevation myocardial infarction - a multicenter experience. J Invasive Cardiol. 2010 Nov;22(11):520-5.
PMID: 21041847RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Galen S Wagner, MD
Duke University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2008
First Posted
May 22, 2008
Study Start
June 1, 2003
Primary Completion
September 1, 2008
Study Completion
May 1, 2010
Last Updated
February 23, 2012
Record last verified: 2012-02