Tele-Electrocardiography in Emergency Cardiac Care - Full Text View

Sponsor:	University of California, San Francisco
Collaborator:	National Institute of Nursing Research (NINR)
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00075088

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Tele-electrocardiography in Emergency Cardiac Care

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain 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 acute myocardial infarction [ Time Frame: Varied, monitored over 5 year span ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rehospitalization and Mortality [ Time Frame: over 5 year span ] [ Designated as safety issue: No ]

Estimated Enrollment:	2468
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: 1	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.
Active Comparator: 2	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

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

Criteria

Inclusion Criteria:

All individuals in Santa Cruz County in California who call 911 and are judged to have a heart attack or severe chest pain.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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.

Responsible Party:	Barbara J. Drew RN, PhD, FAAN; Professor of Nursing & Clinical Professor of Medicine, University of California San Francisco
ClinicalTrials.gov Identifier:	NCT00075088 History of Changes
Obsolete Identifiers:	NCT00305318
Other Study ID Numbers:	1R01NR007881-01A2, R01NR007881
Study First Received:	January 2, 2004
Last Updated:	August 5, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:

Telemedicine
Emergency Care
Cardiac

Additional relevant MeSH terms:

Chest Pain
Emergencies
Infarction
Myocardial Infarction
Pain
Signs and Symptoms
Disease Attributes

Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 12, 2012