STEMI - ST Elevation Myocardial InfarctionTHORNCT06945900
Emergency Medical Services (EMS) Telehealth to Speed STEMI Reperfusion
An observational study of STEMI - ST Elevation Myocardial Infarction, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Telehealth
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients calling 9-1-1 in the Wilkes County that present with a possible STEMI as determined by the on scene paramedics.
Who may be able to join
- 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.
Who cannot join
- As this is a Quality Surveillance study, subjects will not be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Being tested
- Telehealth
- Keywords
- Heart Attack, Reperfusion therapy, Percutaneous Coronary Intervention
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelehealthOther
Paramedics will utilize Telehealth for STEMI patients during transport to determine appropriate care steps.
What is being measured
The primary outcome is the main question the study is designed to answer.
First Medical Contact to Reperfusion Time
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.
Measured: Year 2
First Medical Contact to Electrocardiogram (EKG) time
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.
Measured: Year 2
Electrocardiogram (EKG) to Activation time
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.
Measured: Year 2
Activation to reperfusion [by fibrinolytic or PCI] time)
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.
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start18 Jun 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Simon Mahler, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945900
- Sponsor's protocol ID
- IRB00094324
- Acronym
- THOR
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Medical Services (EMS) Telehealth to Speed STEMI Reperfusion (THOR)
- ClinicalTrials.gov ID
- NCT06945900
- Acronym / sponsor ID
- THOR / IRB00094324
- Keywords
- Heart Attack, Reperfusion therapy, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- The Duke Endowment, Genentech, Inc.
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients calling 9-1-1 in the Wilkes County that present with a possible STEMI as determined by the on scene paramedics.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- As this is a Quality Surveillance study, subjects will not be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelehealthParamedics will utilize Telehealth for STEMI patients during transport to determine appropriate care steps. | Other | – |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Mahler, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI - ST Elevation Myocardial Infarction, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Medical Contact to Reperfusion Time (time frame: Year 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.