Tele-Electrocardiography in Emergency Cardiac Care

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT00075088
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 794
• Location: 1
• Arms: 2
• Duration (Months): 69
• Patients Per Site Per Month: 11.5

Study Details

Study Description

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

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.

Study Design

• Study Type: Interventional
• 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: Sep 1, 2003
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
Other: Routine Clinical Practice Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.	Other: Routine Clinical Practice; ECG in the ED as part of routine clinical practice.

Outcome Measures

Primary Outcome Measures

1. 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

2. Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI) [Day 1]

   Mean door-to-balloon time

Secondary Outcome Measures

1. Rehospitalization and Mortality [4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00075088
• Other Study ID Numbers: 1R01NR007881-01A2; R01NR007881; NCT00305318
• First Posted: Jan 5, 2004
• Last Update Posted: Jun 17, 2015
• Last Verified: May 1, 2015

• Keywords provided by University of California, San Francisco: Telemedicine; Emergency Care; Cardiac
• Additional relevant MeSH terms: Myocardial Infarction; Infarction; Emergencies; Chest Pain

Study Results

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 Detail	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.

Arm/Group Title	Electrocardiogram (ECG) Intervention	Routine Clinical Practice
Arm/Group Description	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.	Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
Period Title: Overall Study
STARTED	403	391
COMPLETED	403	391
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Electrocardiogram (ECG) Intervention	Routine Clinical Practice	Total
Arm/Group Description	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.	Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.	Total of all reporting groups
Overall Participants	403	391	794
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70 (15)	71 (14)	70 (14)
Sex: Female, Male (Count of Participants)
Female	189 46.9%	193 49.4%	382 48.1%
Male	214 53.1%	198 50.6%	412 51.9%
Region of Enrollment (participants) [Number]
United States	403 100%	391 100%	794 100%

Outcome Measures

1. Primary Outcome

Title	Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI
Description	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

Outcome Measure Data

Analysis Population Description

Patients with unstable angina/non-STEMI. Four patients with Do Not Resuscitate (DNR) orders were excluded from this time-to-treatment analysis

Arm/Group Title	Electrocardiogram (ECG) Intervention	Routine Clinical Practice
Arm/Group Description	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.	Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
Measure Participants	23	23
Mean (Standard Deviation) [minutes]	23 (12)	31 (16)

2. Primary Outcome

Title	Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)
Description	Mean door-to-balloon time
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

42 patients with STEMI who received primary percutaneous coronary intervention

Arm/Group Title	Electrocardiogram (ECG) Intervention	Routine Clinical Practice
Arm/Group Description	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.	Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
Measure Participants	28	14
Mean (Standard Deviation) [minutes]	78 (22)	101 (56)

3. Secondary Outcome

Title	Rehospitalization and Mortality
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Electrocardiogram (ECG) Intervention	Routine Clinical Practice
Arm/Group Description	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.	Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
Measure Participants	0	0

Adverse Events

Time Frame	1 month
Adverse Event Reporting Description	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.
Arm/Group Title	Electrocardiogram (ECG) Intervention		Routine Clinical Practice		Prehospital
Arm/Group Description	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.		Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.		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.
All Cause Mortality
	Electrocardiogram (ECG) Intervention		Routine Clinical Practice		Prehospital
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Electrocardiogram (ECG) Intervention		Routine Clinical Practice		Prehospital
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/403 (1.2%)		3/391 (0.8%)		40/40 (100%)
General disorders
Death	5/403 (1.2%)	5	3/391 (0.8%)	3	40/40 (100%)	40
Other (Not Including Serious) Adverse Events
	Electrocardiogram (ECG) Intervention		Routine Clinical Practice		Prehospital
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Sample size was not powered to detect a statistically significant difference in survival between patients with and without a prehospital ECG

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.