Emergency Medical Services (EMS) Telehealth to Speed STEMI Reperfusion (THOR)

April 1, 2026 updated by: Wake Forest University Health Sciences

Emergency Medical Services (EMS) Telehealth to Speed STEMI Reperfusion (THOR)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Medical Contact to Reperfusion Time
Time Frame: Year 2
FMC to reperfusion time will be recorded in a study database. Data will be aggregated from patients before (baseline) and after EMS telehealth STEMI program implementation. FMC to reperfusion time will be reported as a mean with standard deviation and as a median with interquartile range.
Year 2
First Medical Contact to Electrocardiogram (EKG) time
Time Frame: Year 2
FMC to EKG time will be recorded in a study database. Data will be aggregated from patients before (baseline) and after EMS telehealth STEMI program implementation. Time will be reported as a mean with standard deviation and as a median with interquartile range.
Year 2
Electrocardiogram (EKG) to Activation time
Time Frame: Year 2
FMC to activation time will be recorded in a study database. Data will be aggregated from patients before (baseline) and after EMS telehealth STEMI program implementation. Time will be reported as a mean with standard deviation and as a median with interquartile range.
Year 2
Activation to reperfusion [by fibrinolytic or PCI] time)
Time Frame: Year 2
Activation to reperfusion [by fibrinolytic or PCI] time) will be recorded in a study database. Data will be aggregated from patients before (baseline) and after EMS telehealth STEMI program implementation. Time will be reported as a mean with standard deviation and as a median with interquartile range.
Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Genentech, Inc.
The Duke Endowment

Investigators

  • Principal Investigator: Simon Mahler, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00094324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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