Tele-Electrocardiography in Emergency Cardiac Care

NCT ID: NCT00075088

Last Updated: 2015-06-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

794 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction Chest Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Electrocardiogram (ECG) Intervention

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.

Group Type EXPERIMENTAL

Electrocardiogram (ECG) Intervention

Intervention Type DEVICE

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.

Routine Clinical Practice

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

Group Type OTHER

Routine Clinical Practice

Intervention Type OTHER

ECG in the ED as part of routine clinical practice.

Interventions

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Electrocardiogram (ECG) Intervention

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 DEVICE

Routine Clinical Practice

ECG in the ED as part of routine clinical practice.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara J Drew, RN PhD FAAN

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21256997 (View on PubMed)

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.

Reference Type RESULT
PMID: 22115367 (View on PubMed)

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.

Reference Type RESULT
PMID: 21237383 (View on PubMed)

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.

Reference Type RESULT
PMID: 15534844 (View on PubMed)

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.

Reference Type RESULT
PMID: 17015064 (View on PubMed)

Other Identifiers

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R01NR007881

Identifier Type: NIH

Identifier Source: secondary_id

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1R01NR007881-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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NCT00305318

Identifier Type: -

Identifier Source: nct_alias

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