Tele-Electrocardiography in Emergency Cardiac Care
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| ClinicalTrials.gov Identifier: NCT00075088 |
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Recruitment Status
:
Completed
First Posted
: January 5, 2004
Results First Posted
: August 19, 2013
Last Update Posted
: June 17, 2015
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Sponsor:
University of California, San Francisco
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of California, San Francisco
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myocardial Infarction Chest Pain | Device: Electrocardiogram (ECG) Intervention Other: Routine Clinical Practice | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 794 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Tele-electrocardiography in Emergency Cardiac Care |
| Study Start Date : | September 2003 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | June 2009 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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.
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Routine Clinical Practice
Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
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Other: Routine Clinical Practice
ECG in the ED as part of routine clinical practice.
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Primary Outcome Measures
:
- Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI [ Time Frame: 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) [ Time Frame: Day 1 ]Mean door-to-balloon time
Secondary Outcome Measures
:
- Rehospitalization and Mortality [ Time Frame: 4 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075088
Locations
| United States, California | |
| University of California San Francisco | |
| San Francisco, California, United States, 94143 | |
Sponsors and Collaborators
University of California, San Francisco
National Institute of Nursing Research (NINR)
Investigators
| Principal Investigator: | Barbara J Drew, RN PhD FAAN | University of California, San Francisco |
Publications of Results:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00075088 History of Changes |
| Obsolete Identifiers: | NCT00305318 |
| Other Study ID Numbers: |
1R01NR007881-01A2 ( U.S. NIH Grant/Contract ) R01NR007881 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 5, 2004 Key Record Dates |
| Results First Posted: | August 19, 2013 |
| Last Update Posted: | June 17, 2015 |
| Last Verified: | May 2015 |
Keywords provided by University of California, San Francisco:
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Telemedicine Emergency Care Cardiac |
Additional relevant MeSH terms:
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Infarction Myocardial Infarction Emergencies Chest Pain Ischemia Pathologic Processes Necrosis Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Vascular Diseases Disease Attributes Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |