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

February 21, 2012 updated by: Welch Allyn

Pre-hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-held Device: The TIME Multicenter Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

527

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Salinas, California, United States, 93901
        • Salinas Valley Memorial Healthcare System
    • Florida
      • Gainesville, Florida, United States, 32605
        • Shands @ AGH
      • Miami, Florida, United States, 33143
        • South Miami Heart Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27704
        • Durham Regional Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center - Presbyterian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: SmartLink Wireless Monitoring System (K033642)
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.
Other Names:
  • Wireless transmission of ECG with intention to treat with coronary reperfusion therapy.
Post-study period (Group 1)
Post-study period (Group 1). PH-ECG transmission and a STEMI code system implemented after the pilot study period.
Device: SmartLink Wireless Monitoring System (K033642)
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.
Other Names:
  • Wireless transmission of ECG with intention to treat with coronary reperfusion therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Door to intervention time - time from emergency department door time until intervention.
Time Frame: time from emergency department door time until intervention.
time from emergency department door time until intervention.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: pre hospital ECG - discharge ECG
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.
Time Frame: 2 hours after reperfusion treatment
2 hours after reperfusion treatment
Hospital mortality - whether the patient was discharged alive.
Time Frame: discharge
discharge
No infarct related artery at time of heart catheterization.
Time Frame: catheterization
catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Welch Allyn

Collaborators

Duke University

Investigators

  • Principal Investigator: Galen S Wagner, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 12, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimate)

May 22, 2008

Study Record Updates

Last Update Posted (Estimate)

February 23, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIME Multicenter Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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