Clinical trial NCT00682526: Pre-Hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-Held Device
Official title: Pre-hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-held Device: The TIME Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: EMS patients with intention to treat with coronary reperfusion therapy (PCI or thrombolytics) based on their initial presentation
Lead sponsor: Welch Allyn
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2008-05-22
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* Less than age 18
* No intent to undergo reperfusion therapy (PCI or thrombolytics)

Primary outcomes:
measure: Door to intervention time - time from emergency department door time until intervention.
timeFrame: time from emergency department door time until intervention.
Secondary outcomes:
measure: 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.
timeFrame: pre hospital ECG - discharge ECG
measure: 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.
timeFrame: 2 hours after reperfusion treatment
measure: Hospital mortality - whether the patient was discharged alive.
timeFrame: discharge
measure: No infarct related artery at time of heart catheterization.
timeFrame: catheterization
Other outcomes:
Locations:
city: Salinas
country: United States
facility: Salinas Valley Memorial Healthcare System
state: California
city: Gainesville
country: United States
facility: Shands @ AGH
state: Florida
city: Miami
country: United States
facility: South Miami Heart Center
state: Florida
city: Durham
country: United States
facility: Durham Regional Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Presbyterian
state: Pennsylvania
Study officials:
affiliation: Duke University
name: Galen S Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.