Pre-Hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-Held Device

Welch Allyn

Status: Completed

Conditions: Myocardial Infarction

Treatments: Device: SmartLink Wireless Monitoring System (K033642)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00682526

TIME Multicenter Study

Details and patient eligibility

About

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.

Enrollment: 527 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

527 participants in 3 patient groups

Pre-study Period (Group 1 and Group 2).

Description:

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)

Description:

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.

Treatment:

Device: SmartLink Wireless Monitoring System (K033642)

Post-study period (Group 1)

Description:

Post-study period (Group 1). PH-ECG transmission and a STEMI code system implemented after the pilot study period.

Treatment:

Device: SmartLink Wireless Monitoring System (K033642)