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Pre-Hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-Held Device
This study is enrolling participants by invitation only.
First Received: May 12, 2008   Last Updated: May 20, 2008   History of Changes
Sponsors and Collaborators: Welch Allyn
Duke University
Information provided by: Welch Allyn
ClinicalTrials.gov Identifier: NCT00682526
  Purpose

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: Time to reperfusion data will be analyzed on an individual site basis, whereas clinical outcomes data will be pooled from all sites. Statistical analysis will include the Wilcoxon Rank Sum Test and the two-sample t-test (if normally distributed) for continuous variables. The Chi-square test will be used to analyze categorical variables.


Condition Intervention
Myocardial Infarction
Device: SmartLink Wireless Monitoring System (K033642)

Study Type: Observational
Study Design: Case Control
Official Title: Pre-Hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-Held Device: The TIME Multicenter Study

Resource links provided by NLM:


Further study details as provided by Welch Allyn:

Primary Outcome Measures:
  • Door to intervention time - time from emergency department door time until intervention. [ Time Frame: time from emergency department door time until intervention. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Hospital mortality - whether the patient was discharged alive. [ Time Frame: discharge ] [ Designated as safety issue: No ]
  • No infarct related artery at time of heart catheterization. [ Time Frame: catheterization ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 527
Study Start Date: May 2001
Estimated Study Completion Date: December 2008
Groups/Cohorts Assigned Interventions
Phase I

Consecutive Control:

All EMS or self transported patients age 18 or over with the intention to treat with coronary reperfusion therapy (PCI or thrombolytics) based on their initial presentation.

Phase II - I

Intervention Group:

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. This group contains two subgroups:

  1. Patients with successful transmission of their electrocardiogram.
  2. Patients with attempted but failed transmission of their electrocardiogram.
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.
Phase II - C

Concurrent Control:

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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Age 18 or over
  • EMS transported or self transported patients with the intention to undergo reperfusion therapy (PCI or thrombolytics).

Exclusion Criteria:

  • Less than age 18
  • No intent to undergo reperfusion therapy (PCI or thrombolytics)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682526

Locations
United States, California
Salinas Valley Memorial Healthcare System
Salinas, California, United States, 93901
United States, Florida
South Miami Heart Center
Miami, Florida, United States, 33143
Shands @ AGH
Gainesville, Florida, United States, 32605
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Durham Regional Hospital
Durham, North Carolina, United States, 27704
Northeast Medical Center
Concord, North Carolina, United States, 28025
United States, Ohio
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
University of Pittsburgh Medical Center - Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Welch Allyn
Duke University
Investigators
Principal Investigator: Galen S Wagner, MD Duke University
  More Information

No publications provided

Responsible Party: Welch Allyn ( John Seller, RN )
Study ID Numbers: TIME Multicenter Study
Study First Received: May 12, 2008
Last Updated: May 20, 2008
ClinicalTrials.gov Identifier: NCT00682526     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Welch Allyn:
EMS patients with intention to treat with coronary reperfusion therapy (PCI or thrombolytics) based on their initial presentation

Study placed in the following topic categories:
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Fibrinolytic Agents
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on September 10, 2009