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Tele-Electrocardiography in Emergency Cardiac Care

Primary Purpose

Myocardial Infarction, Chest Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Electrocardiogram (ECG) Intervention
Routine Clinical Practice
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring Telemedicine, Emergency Care, Cardiac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All individuals in Santa Cruz County in California who call 911 with symptoms of acute coronary syndrome (chest pain, shortness of breath, anginal equivalent). Exclusion Criteria: Those who don't meet the above inclusion criteria.

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Electrocardiogram (ECG) Intervention

Routine Clinical Practice

Arm Description

Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.

Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.

Outcomes

Primary Outcome Measures

Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI
Time from ED arrival to first drug was determined as recommended by American College of Cardiology/American Heart Association 2007 guidelines for management of patients with unstable angina/non-STEMI
Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)
Mean door-to-balloon time

Secondary Outcome Measures

Rehospitalization and Mortality

Full Information

First Posted
January 2, 2004
Last Updated
May 15, 2015
Sponsor
University of California, San Francisco
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00075088
Brief Title
Tele-Electrocardiography in Emergency Cardiac Care
Official Title
Tele-electrocardiography in Emergency Cardiac Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to see whether individuals who access the "911" emergency medical system with a heart attack or severe chest pain will receive more timely hospital treatment and better outcomes if hospital clinicians are provided with earlier and more complete electrocardiography (ECG) information.
Detailed Description
This is a Phase III study. Patients will be randomized (like tossing a coin) to 1 of 2 groups: Group 1: Patients will have pre-hospital ECG intervention. Group 2: Patients will have routine emergency heart care. Information will be collected about time symptoms started, clinical management, and other measures. All patients will be contacted by telephone 12 months later and interviewed as to whether they experienced any cardiac symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Chest Pain
Keywords
Telemedicine, Emergency Care, Cardiac

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
794 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrocardiogram (ECG) Intervention
Arm Type
Experimental
Arm Description
Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
Arm Title
Routine Clinical Practice
Arm Type
Other
Arm Description
Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
Intervention Type
Device
Intervention Name(s)
Electrocardiogram (ECG) Intervention
Intervention Description
Pre-hospital electrocardiographic (ECG) monitoring with special software to detect myocardial ischemia and to automatically transmit an ECG to the destination hospital emergency department with a voice alarm announcing "Incoming ECG from the field" and print out in the ED.
Intervention Type
Other
Intervention Name(s)
Routine Clinical Practice
Intervention Description
ECG in the ED as part of routine clinical practice.
Primary Outcome Measure Information:
Title
Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI
Description
Time from ED arrival to first drug was determined as recommended by American College of Cardiology/American Heart Association 2007 guidelines for management of patients with unstable angina/non-STEMI
Time Frame
Day 1
Title
Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)
Description
Mean door-to-balloon time
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Rehospitalization and Mortality
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All individuals in Santa Cruz County in California who call 911 with symptoms of acute coronary syndrome (chest pain, shortness of breath, anginal equivalent). Exclusion Criteria: Those who don't meet the above inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J Drew, RN PhD FAAN
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21256997
Citation
Drew BJ, Sommargren CE, Schindler DM, Benedict K, Zegre-Hemsey J, Glancy JP. A simple strategy improves prehospital electrocardiogram utilization and hospital treatment for patients with acute coronary syndrome (from the ST SMART Study). Am J Cardiol. 2011 Feb 1;107(3):347-52. doi: 10.1016/j.amjcard.2010.09.027.
Results Reference
result
PubMed Identifier
22115367
Citation
Zegre Hemsey JK, Dracup K, Fleischmann K, Sommargren CE, Drew BJ. Prehospital 12-lead ST-segment monitoring improves the early diagnosis of acute coronary syndrome. J Electrocardiol. 2012 May-Jun;45(3):266-71. doi: 10.1016/j.jelectrocard.2011.10.004. Epub 2011 Nov 23.
Results Reference
result
PubMed Identifier
21237383
Citation
Zegre-Hemsey J, Sommargren CE, Drew BJ. Initial ECG acquisition within 10 minutes of arrival at the emergency department in persons with chest pain: time and gender differences. J Emerg Nurs. 2011 Jan;37(1):109-12. doi: 10.1016/j.jen.2009.11.004. Epub 2009 Dec 11.
Results Reference
result
PubMed Identifier
15534844
Citation
Drew BJ, Dempsey ED, Joo TH, Sommargren CE, Glancy JP, Benedict K, Krucoff MW. Pre-hospital synthesized 12-lead ECG ischemia monitoring with trans-telephonic transmission in acute coronary syndromes: pilot study results of the ST SMART trial. J Electrocardiol. 2004;37 Suppl:214-21. doi: 10.1016/j.jelectrocard.2004.08.060.
Results Reference
result
PubMed Identifier
17015064
Citation
Drew BJ, Sommargren CE, Schindler DM, Zegre J, Benedict K, Krucoff MW. Novel electrocardiogram configurations and transmission procedures in the prehospital setting: effect on ischemia and arrhythmia determination. J Electrocardiol. 2006 Oct;39(4 Suppl):S157-60. doi: 10.1016/j.jelectrocard.2006.05.033.
Results Reference
result

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Tele-Electrocardiography in Emergency Cardiac Care

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