Clinical trial NCT06945900: Emergency Medical Services (EMS) Telehealth to Speed STEMI Reperfusion
Official title: Emergency Medical Services (EMS) Telehealth to Speed STEMI Reperfusion (THOR)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: STEMI - ST Elevation Myocardial Infarction
Keywords: Heart Attack
Reperfusion therapy
Percutaneous Coronary Intervention
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: The Duke Endowment
name: Genentech, Inc.
First posted: 2025-04-27
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients calling 9-1-1 in the Wilkes County that present with a possible STEMI as determined by the on scene paramedics.

Brief summary: The aim of this study is to evaluate the impact of a Telehealth program on the time from First Medical Contact (FMC) to Reperfusion in STEMI (ST-elevation myocardial infarction) patients, by supporting local paramedics in their care delivery.

Detailed description: STEMI (ST-elevation myocardial infarction) is the most severe type of heart attack and carries a 30-day mortality of nearly 8%. Reperfusion therapy is the mainstay of treatment for STEMI, either by percutaneous coronary intervention (PCI) or fibrinolytics. Delays in reperfusion are associated with negative health outcomes. Specifically, each 30-minute delay in reperfusion corresponds to a 7.5% decrease in 1-year survival. The current body of literature clearly shows that rural EMS agencies often have longer transport times, which makes the 90-minute first medical contact (FMC) to PCI time goal difficult to achieve. Approximately 16% of Americans live more than an hour from a PCI-capable facility, reinforcing the need for timely therapies in rural prehospital settings to decrease heart muscle damage (disability) and mortality. An analysis of a large national EMS database, which showed that FMC to PCI times were longer for patients treated by rural EMS agencies even after these times were adjusted for distance to destination hospital.8In addition, preliminary data for Cherokee Tribal EMS, serving the Eastern Band of Cherokee Indians on the Qualla Boundary and its surrounding communities, show that none of their patients who called 9-1-1 for a STEMI received reperfusion within the AHA time goal. The American College of Cardiology and AHA support prehospital fibrinolytics when timely PCI cannot be performed. STEMI telehealth programs have yet to be implemented and tested in the United States.

Eligibility criteria: Inclusion Criteria:

* All patients calling 9-1-1 in Wilkes County with possible STEMI as determined by the on scene paramedics will be included in the data.

Exclusion Criteria:

* As this is a Quality Surveillance study, subjects will not be excluded.

Primary outcomes:
measure: First Medical Contact to Reperfusion Time
timeFrame: Year 2
measure: First Medical Contact to Electrocardiogram (EKG) time
timeFrame: Year 2
measure: Electrocardiogram (EKG) to Activation time
timeFrame: Year 2
measure: Activation to reperfusion [by fibrinolytic or PCI] time)
timeFrame: Year 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jason Stopyra, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: