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| Sponsored by: |
National Institute of Nursing Research (NINR) |
|---|---|
| Information provided by: | National Institute of Nursing Research (NINR) |
| ClinicalTrials.gov Identifier: | NCT00075088 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction Chest Pain |
Device: Electrocardiogram (ECG) Intervention Other: Routine Clinical Practice |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Tele-Electrocardiography in Emergency Cardiac Care |
| Estimated Enrollment: | 2468 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
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.
|
| 2: Active Comparator |
Other: Routine Clinical Practice
ECG in the ED as part of routine clinical practice.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| United States, California | |
| University of California San Francisco | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | Barbara J Drew, RN, PhD, FAAN | University of California, San Francisco |
More Information
| Responsible Party: | University of California San Francisco ( Barbara J. Drew RN, PhD, FAAN; Professor of Nursing & Clinical Professor of Medicine ) |
| Study ID Numbers: | 1R01NR007881-01A2 |
| Study First Received: | January 2, 2004 |
| Last Updated: | January 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00075088 History of Changes |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
Telemedicine Emergency Care Cardiac |
|
Signs and Symptoms Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases Emergencies |
Pain Ischemia Infarction Myocardial Infarction Chest Pain |
|
Disease Attributes Heart Diseases Myocardial Ischemia Vascular Diseases Pain Ischemia Chest Pain |
Signs and Symptoms Necrosis Pathologic Processes Emergencies Cardiovascular Diseases Infarction Myocardial Infarction |
