Chest Pain, Myocardial Infarction
Conditions
Keywords
Telemedicine, Emergency Care, Cardiac
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.
Interventions
DEVICEElectrocardiogram (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.
ECG in the ED as part of routine clinical practice.
Sponsors
National Institute of Nursing Research (NINR)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI | 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) | Day 1 | Mean door-to-balloon time |
Secondary
| Measure | Time frame |
|---|---|
| Rehospitalization and Mortality | 4 years |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 403 |
| Routine Clinical Practice Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county. | 391 |
| Total | 794 |
Baseline characteristics
| Characteristic | Electrocardiogram (ECG) Intervention | Routine Clinical Practice | Total |
|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 15 | 71 years STANDARD_DEVIATION 14 | 70 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 403 participants | 391 participants | 794 participants |
| Sex: Female, Male Female | 189 Participants | 193 Participants | 382 Participants |
| Sex: Female, Male Male | 214 Participants | 198 Participants | 412 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 5 / 403 | 3 / 391 | 40 / 40 |
Outcome results
Primary
Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)
Mean door-to-balloon time
Time frame: Day 1
Population: 42 patients with STEMI who received primary percutaneous coronary intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electrocardiogram (ECG) Intervention | Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI) | 78 minutes | Standard Deviation 22 |
| Routine Clinical Practice | Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI) | 101 minutes | Standard Deviation 56 |
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
Time frame: Day 1
Population: Patients with unstable angina/non-STEMI. Four patients with Do Not Resuscitate (DNR) orders were excluded from this time-to-treatment analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electrocardiogram (ECG) Intervention | Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI | 23 minutes | Standard Deviation 12 |
| Routine Clinical Practice | Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI | 31 minutes | Standard Deviation 16 |
Secondary
Rehospitalization and Mortality
Time frame: 4 years
Population: 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.