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Completed

NCT Number: NCT00682526

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Salinas Valley Memorial Healthcare System, Salinas, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SmartLink Wireless Monitoring System (K033642)

Device

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.

Primary outcomes

  1. Door to intervention time - time from emergency department door time until intervention.

    Time frame: time from emergency department door time until intervention.

Secondary outcomes

  1. 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

  2. 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

  3. Hospital mortality - whether the patient was discharged alive.

    Time frame: discharge

  4. No infarct related artery at time of heart catheterization.

    Time frame: catheterization

Sponsors and collaborators

Lead sponsor

Welch Allyn

Industry

Collaborators

  • Duke University

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2010
First posted
May 22, 2008
Registry last updated
Feb 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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