| ID | Type | Description | Link |
|---|---|---|---|
| R01NR007881 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrocardiogram (ECG) Intervention | Experimental | 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. |
|
| Routine Clinical Practice | Other | Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocardiogram (ECG) Intervention | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rehospitalization and Mortality | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J Drew, RN PhD FAAN | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21256997 | Result | 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. | |
| 22115367 | Result | 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. |
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4,219 calls to 911 for ACS symptoms were made over the study period; 3,103 pre-hospital ECGs were transmitted by paramedics; 2,353 ECGs were successfully received by the target emergency department (ED); 794 patients consented. If patient consent was not obtained, data were not used.
For 5-years, paramedics responding to 911 calls for symptoms suggestive of Acute Coronary Syndrome (ACS) in one U.S. county transmitted an electrocardiogram (ECG) to the target emergency department (ED) for all patients meeting eligibility criteria. A central computer received the transmission and randomized to an experimental or control group.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Routine Clinical Practice | Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Routine Clinical Practice |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Patients with unstable angina/non-STEMI. Four patients with Do Not Resuscitate (DNR) orders were excluded from this time-to-treatment analysis | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
1 month
Due to the low-risk intervention relative to participants' serious health condition, AEs were not collected if they did not meet the criteria for SAEs or were at least possibly attributable to study procedures (none were).
Consented patients who died during the index hospitalization were reported. 786 were discharged alive.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders |
|
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Sample size was not powered to detect a statistically significant difference in survival between patients with and without a prehospital ECG
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara J Drew, PhD | University of California, San Francisco | 415-476-4302 | barbara.drew@nursing.ucsf.edu |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D008722 | Methods |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Routine Clinical Practice | Other | ECG in the ED as part of routine clinical practice. |
|
| 21237383 | Result | 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. |
| 15534844 | Result | 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. |
| 17015064 | Result | 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. |
Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county. |
|
|
| Primary | Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI) | Mean door-to-balloon time | 42 patients with STEMI who received primary percutaneous coronary intervention | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| Secondary | Rehospitalization and Mortality | we did not have the resources to achieve this secondary aim that required long-term follow up (a labor intensive job). The PI is now retired. | Posted | 4 years |
|
|
| 5 |
| 403 |
| 0 |
| 0 |
| EG001 | Routine Clinical Practice | Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county. | 3 | 391 | 0 | 0 |
| EG002 | Prehospital | At the start of the trial, the IRB requested every death in the pre-hospital period be reported because we put on the study electrocardiogram device in the field with waiver of consent so as not to cause a delay for patients reaching the hospital with possible heart attack. They were consented after they reached the hospital. However, IRB removed this requirement after 40 pre-consent/pre-hospital deaths were reported. The number of pre-hospital participants assessed before and after the IRB changed the reporting requirements cannot be determined from study data, but "NA" is not a valid entry in the "At Risk" field. | 40 | 40 | 0 | 0 |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D004568 | Electrodiagnosis |
| D008919 | Investigative Techniques |