Tele-Electrocardiography in Emergency Cardiac Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00075088
First received: January 2, 2004
Last updated: August 16, 2013
Last verified: August 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Tele-electrocardiography in Emergency Cardiac Care

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Mean door-to-balloon time


Secondary Outcome Measures:
  • Rehospitalization and Mortality [ Time Frame: 4 years ] [ Designated as safety issue: No ]

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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: 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
Results First Received: June 8, 2013
Last Updated: August 16, 2013
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 August 18, 2014