NCT06945900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 18, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 15, 2025

Last Update Submit

April 1, 2026

Conditions

Keywords

Heart AttackReperfusion therapyPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Year 2

Interventions

Paramedics will utilize Telehealth for STEMI patients during transport to determine appropriate care steps.

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Simon Mahler, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2025

First Posted

April 27, 2025

Study Start

June 18, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 2, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations