Tele-Electrocardiography in Emergency Cardiac Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tele-electrocardiography in Emergency Cardiac Care

Conditions
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Myocardial Infarction, Chest Pain

Intervention / Treatment
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* Device: Electrocardiogram (ECG) Intervention
* Other: Routine Clinical Practice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrocardiogram (ECG) Intervention<br>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<br>* 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.<br>|
| Other: Routine Clinical Practice<br>Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county. | Other: Routine Clinical Practice<br>* ECG in the ED as part of routine clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization and Mortality |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Emergency Care, Cardiac