NCT04617834

Brief Summary

This pre-post study will evaluate the implementation of a cardiovascular telehealth platform, which will connect experts from the Wake Forest University Health Sciences (WFUHS) tertiary care center with Wilkes County Emergency Medical Services (WC-EMS) system, Wilkes Medical Center Emergency Department (ED), and The Wilkes County Health Department Public Health Community Clinic (PHCC) to improve cardiovascular care in this rural community.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
active not recruiting

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

Study Progress96%
Feb 2021Aug 2026

First Submitted

Initial submission to the registry

October 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

January 27, 2026

Status Verified

August 1, 2025

Enrollment Period

4.6 years

First QC Date

October 30, 2020

Last Update Submit

January 26, 2026

Conditions

Keywords

acute chest paintelehealthimplementation sciencerural health

Outcome Measures

Primary Outcomes (1)

  • Number of Emergency Department (ED) utilization

    ED utilization among patients with cardiovascular symptoms will be defined as the total number of cardiovascular-related ED admissions divided by the total number of unique individual patients receiving cardiovascular care during the project period.

    baseline

Secondary Outcomes (11)

  • Number of Cardiovascular hospitalizations

    Baseline

  • Number of Cardiovascular Inter-facility transfers

    Baseline

  • Number of 30-day cardiovascular Emergency Department (ED) re-admissions

    day 30

  • Number of 30-day cardiovascular hospital re-admissions

    day 30

  • Number of Adverse Events

    day 30 and Month 12

  • +6 more secondary outcomes

Other Outcomes (3)

  • (ED) Emergency Department length of stay (LOS)

    Baseline

  • Time to transfer

    Baseline

  • Patient satisfaction Score

    Day 30 and year 1

Study Arms (1)

Quality Surveillance Data

For this quality surveillance study, data will be collected retrospectively through electronic health record (EHR) queries for all eligible patients treated for acute cardiovascular symptoms by one of the study sites.

Other: Quality Surveillance Data Collection

Interventions

Data will be retrospectively collected through EHR queries

Quality Surveillance Data

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The target population is adult patients with cardiovascular symptoms. Therefore, adult patients (\>18 years old) with acute chest pain or dyspnea concerning for acute cardiovascular disease will be eligible.

You may qualify if:

  • age \> 18 years at time of index encounter
  • Cardiovascular symptoms (chest discomfort or dyspnea consistent with possible ACS) as indicated by the treating provider

You may not qualify if:

  • Age \<18
  • Traumatic chest pain
  • Dyspnea that is clearly from a non-cardiac etiology
  • Patients with hemodynamic instability SBP \< 90 mmHg, HR\>160 or \<40 bpm
  • Patients requiring intubation/mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Wilkes County Emergency Medical Services

Wilkesboro, North Carolina, 28697, United States

Location

Wilkes County Public Health Community Clinic

Wilkesboro, North Carolina, 28697, United States

Location

Wilkes Medical Center

Wilkesboro, North Carolina, 28697, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

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Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular Diseases

Study Officials

  • Simon A Mahler, MD, MS

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 5, 2020

Study Start

February 1, 2021

Primary Completion

August 31, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

January 27, 2026

Record last verified: 2025-08

Locations