Tele-Electrocardiography in Emergency Cardiac Care

Phase 3

Completed

• Conditions: Chest Pain; Myocardial Infarction
• Interventions: Other: Routine Clinical Practice; Device: Electrocardiogram (ECG) Intervention

• Registration Number: NCT00075088
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-09
• Study First Submitted: 2004-01-02
• Study First Submitted QC: 2004-01-02
• Study First Posted: 2004-01-05
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2013-06-08
• Results First Submitted QC: 2013-08-16
• Results First Posted: 2013-08-19
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-15
• Last Update Posted: 2015-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 794

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Clinical Practice	Routine Clinical Practice	Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
Electrocardiogram (ECG) Intervention	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.

Primary Outcome Measures

Name	Time	Method
Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI	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
Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)	Day 1	Mean door-to-balloon time

Secondary Outcome Measures

Name	Time	Method
Rehospitalization and Mortality	4 years

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States