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Tele-Electrocardiography in Emergency Cardiac Care

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ClinicalTrials.gov Identifier: NCT00075088
Recruitment Status : Completed
First Posted : January 5, 2004
Results First Posted : August 19, 2013
Last Update Posted : June 17, 2015
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of California, San Francisco

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 794 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tele-electrocardiography in Emergency Cardiac Care
Study Start Date : September 2003
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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

  2. Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI) [ Time Frame: Day 1 ]
    Mean door-to-balloon time


Secondary Outcome Measures :
  1. Rehospitalization and Mortality [ Time Frame: 4 years ]


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.

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

Publications:
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 Posted: January 5, 2004    Key Record Dates
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