Clinical trial NCT00075088: Tele-Electrocardiography in Emergency Cardiac Care
Official title: Tele-electrocardiography in Emergency Cardiac Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Chest Pain
Keywords: Telemedicine
Emergency Care
Cardiac
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2004-01-05
Enrollment: 794
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI
timeFrame: Day 1
measure: Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)
timeFrame: Day 1
Secondary outcomes:
measure: Rehospitalization and Mortality
timeFrame: 4 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Barbara J Drew, RN PhD FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.