Tele-Electrocardiography in Emergency Cardiac Care

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00075088

First Posted: January 5, 2004

Last Update Posted: June 17, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Institute of Nursing Research (NINR)

Information provided by (Responsible Party):

University of California, San Francisco

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction Chest Pain	Device: Electrocardiogram (ECG) Intervention Other: Routine Clinical Practice	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic
Official Title:	Tele-electrocardiography in Emergency Cardiac Care

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain Health Facilities Heart Attack

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI [ Time Frame: Day 1 ]
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) [ Time Frame: Day 1 ]
Mean door-to-balloon time

Secondary Outcome Measures:

Rehospitalization and Mortality [ Time Frame: 4 years ]


Enrollment:	794
Study Start Date:	September 2003
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Device: 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.
Routine Clinical Practice Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.	Other: Routine Clinical Practice ECG in the ED as part of routine clinical practice.

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075088

Locations


United States, California
University of California San Francisco
San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

National Institute of Nursing Research (NINR)

Investigators


Principal Investigator:	Barbara J Drew, RN PhD FAAN	University of California, San Francisco

More Information

Publications:

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.

Zègre 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.

Zègre-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.

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.

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.


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00075088 History of Changes
Obsolete Identifiers:	NCT00305318
Other Study ID Numbers:	1R01NR007881-01A2 ( U.S. NIH Grant/Contract ) R01NR007881 ( U.S. NIH Grant/Contract )
First Submitted:	January 2, 2004
First Posted:	January 5, 2004
Results First Submitted:	June 8, 2013
Results First Posted:	August 19, 2013
Last Update Posted:	June 17, 2015
Last Verified:	May 2015

Keywords provided by University of California, San Francisco:


Telemedicine Emergency Care Cardiac

Additional relevant MeSH terms:


Infarction Myocardial Infarction Emergencies Chest Pain Ischemia Pathologic Processes Necrosis Myocardial Ischemia	Heart Diseases Cardiovascular Diseases Vascular Diseases Disease Attributes Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms

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