Tele-Electrocardiography in Emergency Cardiac Care - Tabular View

Tracking Information

First Received Date ^ICMJE

January 2, 2004

Last Updated Date

January 21, 2009

Start Date ^ICMJE

September 2003

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hospital time to treatment for patients with acute myocardial infarction [ Time Frame: Varied, monitored over 5 year span ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00075088 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Tele-Electrocardiography in Emergency Cardiac Care

Official Title ^ICMJE

Tele-Electrocardiography in Emergency Cardiac Care

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Myocardial Infarction
Chest Pain

Intervention ^ICMJE

Device: Electrocardiogram (ECG) Intervention
Other: Routine Clinical Practice

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

2468

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00075088

Responsible Party

Barbara J. Drew RN, PhD, FAAN; Professor of Nursing & Clinical Professor of Medicine, University of California San Francisco

Study ID Numbers ^ICMJE

1R01NR007881-01A2

Study Sponsor ^ICMJE

National Institute of Nursing Research (NINR)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Barbara J Drew, RN, PhD, FAAN

University of California, San Francisco

Information Provided By

National Institute of Nursing Research (NINR)

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP