NCT00075088

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
794

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2004

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

August 19, 2013

Completed
Last Updated

June 17, 2015

Status Verified

May 1, 2015

Enrollment Period

5.8 years

First QC Date

January 2, 2004

Results QC Date

June 8, 2013

Last Update Submit

May 15, 2015

Conditions

Keywords

TelemedicineEmergency CareCardiac

Outcome Measures

Primary Outcomes (2)

  • Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI

    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

    Day 1

  • Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)

    Mean door-to-balloon time

    Day 1

Secondary Outcomes (1)

  • Rehospitalization and Mortality

    4 years

Study Arms (2)

Electrocardiogram (ECG) Intervention

EXPERIMENTAL

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

Routine Clinical Practice

OTHER

Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.

Other: Routine Clinical Practice

Interventions

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.

Electrocardiogram (ECG) Intervention

ECG in the ED as part of routine clinical practice.

Routine Clinical Practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All individuals in Santa Cruz County in California who call 911 with symptoms of acute coronary syndrome (chest pain, shortness of breath, anginal equivalent).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (5)

  • 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.

  • Zegre 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.

  • Zegre-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. doi: 10.1016/j.jelectrocard.2004.08.060.

  • 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. doi: 10.1016/j.jelectrocard.2006.05.033.

MeSH Terms

Conditions

Myocardial InfarctionChest Pain

Interventions

ElectrocardiographyMethods

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisInvestigative Techniques

Limitations and Caveats

Sample size was not powered to detect a statistically significant difference in survival between patients with and without a prehospital ECG

Results Point of Contact

Title
Barbara J Drew, PhD
Organization
University of California, San Francisco

Study Officials

  • Barbara J Drew, RN PhD FAAN

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2004

First Posted

January 5, 2004

Study Start

September 1, 2003

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 17, 2015

Results First Posted

August 19, 2013

Record last verified: 2015-05

Locations