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

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Welch Allyn
ClinicalTrials.gov Identifier:
NCT00682526
First received: May 12, 2008
Last updated: February 21, 2012
Last verified: February 2012
  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: 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.


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

Study Type: Observational
Study Design: Observational Model: 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 ]

Enrollment: 527
Study Start Date: June 2003
Study Completion Date: May 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Wireless transmission of ECG with intention to treat with coronary reperfusion therapy.

  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:

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Shands @ AGH
Gainesville, Florida, United States, 32605
South Miami Heart Center
Miami, Florida, United States, 33143
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Durham Regional Hospital
Durham, North Carolina, United States, 27704
United States, Ohio
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
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

Publications:
Responsible Party: Welch Allyn
ClinicalTrials.gov Identifier: NCT00682526     History of Changes
Other Study ID Numbers: TIME Multicenter Study
Study First Received: May 12, 2008
Last Updated: February 21, 2012
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

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

ClinicalTrials.gov processed this record on July 22, 2014