Trial Outcomes & Findings for Tele-Electrocardiography in Emergency Cardiac Care (NCT NCT00075088)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

794 participants

Primary outcome timeframe

Day 1

Results posted on

2015-06-17

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	Routine Clinical Practice Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
Overall Study STARTED	403	391
Overall Study COMPLETED	403	391
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tele-Electrocardiography in Emergency Cardiac Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electrocardiogram (ECG) Intervention n=403 Participants 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 n=391 Participants Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.	Total n=794 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 15 • n=93 Participants	71 years STANDARD_DEVIATION 14 • n=4 Participants	70 years STANDARD_DEVIATION 14 • n=27 Participants
Sex: Female, Male Female	189 Participants n=93 Participants	193 Participants n=4 Participants	382 Participants n=27 Participants
Sex: Female, Male Male	214 Participants n=93 Participants	198 Participants n=4 Participants	412 Participants n=27 Participants
Region of Enrollment United States	403 participants n=93 Participants	391 participants n=4 Participants	794 participants n=27 Participants

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Electrocardiogram (ECG) Intervention n=23 Participants 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 n=23 Participants Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI	23 minutes Standard Deviation 12	31 minutes Standard Deviation 16

PRIMARY outcome

Timeframe: Day 1

Population: 42 patients with STEMI who received primary percutaneous coronary intervention

Mean door-to-balloon time

Outcome measures

Outcome measures
Measure	Electrocardiogram (ECG) Intervention n=28 Participants 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 n=14 Participants Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)	78 minutes Standard Deviation 22	101 minutes Standard Deviation 56

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Electrocardiogram (ECG) Intervention

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Routine Clinical Practice

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Prehospital

Serious events: 40 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Electrocardiogram (ECG) Intervention n=403 participants at risk 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 n=391 participants at risk Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.	Prehospital n=40 participants at risk 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.
General disorders Death	1.2% 5/403 • Number of events 5 • 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.	0.77% 3/391 • Number of events 3 • 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.	100.0% 40/40 • Number of events 40 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Barbara J Drew, PhD

University of California, San Francisco

Phone: 415-476-4302

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place