Cardiovascular DiseasesE-VICTORSNCT04617834
Enhancing Rural Health Via Cardiovascular Telehealth for Rural Patients Implementation (E-VICTORS)
An observational study of Cardiovascular Diseases and Acute Coronary Syndrome, run by Wake Forest University Health Sciences at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Acute Coronary Syndrome
- What is being tested?
- Quality Surveillance Data Collection
- How many people
- 215 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Feb 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age > 18 years at time of index encounter
- Cardiovascular symptoms (chest discomfort or dyspnea consistent with possible ACS) as indicated by the treating provider
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Wilkes County Emergency Medical Services
Wilkesboro, North Carolina, 28697
Wilkes County Public Health Community Clinic
Wilkesboro, North Carolina, 28697
Wilkes Medical Center
Wilkesboro, North Carolina, 28697
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Enhancing Rural Health Via Cardiovascular Telehealth for Rural Patients (E-VICTORS) Project
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.
Read the detailed description
This program aims to improve cardiovascular care for patients in Wilkes County by implementing a cardiovascular telehealth program designed to; a) assist WC- EMS paramedics with the early risk stratification (electrocardiogram (EKG) interpretation, vital signs, and risk scores), treatment, and transportation destination decisions in patients with acute chest pain or dyspnea, b) support Wilkes Medical Center (WMC) Emergency Department (ED) providers (physicians and advanced practice clinicians) in the evaluation, management, and disposition of patients with acute cardiovascular symptoms, and c) provide consultative expertise to the Primary Health Care Centers (PHCC) for patients seen following an EMS or ED encounter for cardiovascular symptoms.
- Conditions
- Cardiovascular Diseases, Acute Coronary Syndrome
- Being tested
- Quality Surveillance Data Collection
- Keywords
- acute chest pain, telehealth, implementation science, rural health
- Medical subject headings
- Cardiovascular Diseases, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Surveillance Data CollectionOther
Data will be retrospectively collected through EHR queries
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quality Surveillance Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (11)
Number of Cardiovascular hospitalizations
Cardiovascular hospitalizations will be defined as an inpatient or observation admission for cardiovascular conditions or symptoms based on Current Procedures Terminology (CPT) and International Classification of Diseases (ICD) codes
Measured: Baseline
Number of Cardiovascular Inter-facility transfers
Cardiovascular Inter-facility transfers will be defined based on patients with cardiovascular symptoms or conditions transferred from Wilkes Medical Center (WMC) to another hospital.
Measured: Baseline
Number of 30-day cardiovascular Emergency Department (ED) re-admissions
30-day cardiovascular ED re-admissions will be defined as any cardiovascular related ED admission occurring during the 30 days following their initial/index ED encounter.
Measured: day 30
Number of 30-day cardiovascular hospital re-admissions
30-day cardiovascular hospital re-admissions will be defined as any cardiovascular related hospital admission occurring during the 30 days following their index hospitalization.
Measured: day 30
Number of Adverse Events
Determine if telehealth implementation will result in improved sorting of cases for escalated and de-escalated care, reducing the number of adverse events.
Measured: day 30 and Month 12
Change in Cost - societal level
Evaluate whether spending on healthcare (i.e., insurance payments) changes during the 30-day follow-up period.
Measured: day 30 and Month 12
Change in Cost - provider level
Estimates will be obtained for the impact of the establishment of the telehealth program on the budget of the tertiary center.
Measured: day 30 and Month 12
Cost-effectiveness
Cost-effectiveness: will be evaluated at the societal level to inform the relative changes in patient outcomes and costs resulting from the telehealth program.
Measured: Month 12 and Month 48
Cardiovascular telehealth consultation rate
Cardiovascular telehealth consultation rate will be assessed by identifying the total number of patients that received cardiovascular telehealth consultations at each originating site divided by the total number of patients at each originating site with cardiovascular symptoms.
Measured: Baseline
Cardiovascular telehealth adoption rate
Adoption rate will be defined by the cardiovascular telehealth consultation rate at each originating site during the first 12 months following implementation of the cardiovascular telehealth service.
Measured: Month 12
Cardiovascular telehealth sustainability rate
Sustainability rate will be defined by the cardiovascular telehealth consultation rate at each site greater than 12 months after the availability of the cardiovascular telehealth service.
Measured: Month 24 - Month 48 post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Feb 2021
- Primary completion31 Aug 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Simon A Mahler, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617834
- Sponsor's protocol ID
- IRB00068612
- Acronym
- E-VICTORS
- Status last verified
- Jul 2026
- First submitted
- 30 Oct 2020
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Stafford R, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):948-54. doi: 10.1161/CIRCULATIONAHA.109.192666. No abstract available.
PubMed 20177011Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):143-52. doi: 10.1161/CIR.0b013e318282ab8f. No abstract available.
PubMed 23283859Jollis JG, Al-Khalidi HR, Roettig ML, Berger PB, Corbett CC, Doerfler SM, Fordyce CB, Henry TD, Hollowell L, Magdon-Ismail Z, Kochar A, McCarthy JJ, Monk L, O'Brien P, Rea TD, Shavadia J, Tamis-Holland J, Wilson BH, Ziada KM, Granger CB. Impact of Regionalization of ST-Segment-Elevation Myocardial Infarction Care on Treatment Times and Outcomes for Emergency Medical Services-Transported Patients Presenting to Hospitals With Percutaneous Coronary Intervention: Mission: Lifeline Accelerator-2. Circulation. 2018 Jan 23;137(4):376-387. doi: 10.1161/CIRCULATIONAHA.117.032446. Epub 2017 Nov 14.
PubMed 29138292Abrams TE, Vaughan-Sarrazin M, Kaboli PJ. Mortality and revascularization following admission for acute myocardial infarction: implication for rural veterans. J Rural Health. 2010 Fall;26(4):310-7. doi: 10.1111/j.1748-0361.2010.00318.x. Epub 2010 Aug 17.
PubMed 21029165Lambert L, Brown K, Segal E, Brophy J, Rodes-Cabau J, Bogaty P. Association between timeliness of reperfusion therapy and clinical outcomes in ST-elevation myocardial infarction. JAMA. 2010 Jun 2;303(21):2148-55. doi: 10.1001/jama.2010.712.
PubMed 20516415James CV, Moonesinghe R, Wilson-Frederick SM, Hall JE, Penman-Aguilar A, Bouye K. Racial/Ethnic Health Disparities Among Rural Adults-United States, 2012-2015: MMWR Surveillance Summaries / November 17, 2017 / 66(23);1-9. J Health Care Poor Underserved. 2018;29(1):19-34. doi: 10.1353/hpu.2018.0003.
PubMed 29503284O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013 Jul 1;82(1):E1-27. doi: 10.1002/ccd.24776. Epub 2013 Jan 8. No abstract available.
PubMed 23299937Harrington RA, Califf RM, Balamurugan A, Brown N, Benjamin RM, Braund WE, Hipp J, Konig M, Sanchez E, Joynt Maddox KE. Call to Action: Rural Health: A Presidential Advisory From the American Heart Association and American Stroke Association. Circulation. 2020 Mar 10;141(10):e615-e644. doi: 10.1161/CIR.0000000000000753. Epub 2020 Feb 10.
PubMed 32078375Mahler SA, Hiestand BC, Goff DC Jr, Hoekstra JW, Miller CD. Can the HEART score safely reduce stress testing and cardiac imaging in patients at low risk for major adverse cardiac events? Crit Pathw Cardiol. 2011 Sep;10(3):128-33. doi: 10.1097/HPC.0b013e3182315a85.
PubMed 21989033Mahler SA, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD. The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):195-203. doi: 10.1161/CIRCOUTCOMES.114.001384. Epub 2015 Mar 3.
PubMed 25737484Mahler SA, Lenoir KM, Wells BJ, Burke GL, Duncan PW, Case LD, Herrington DM, Diaz-Garelli JF, Futrell WM, Hiestand BC, Miller CD. Safely Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge. Circulation. 2018 Nov 27;138(22):2456-2468. doi: 10.1161/CIRCULATIONAHA.118.036528.
PubMed 30571347Stopyra JP, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD, Mahler SA. The HEART Pathway Randomized Controlled Trial One-year Outcomes. Acad Emerg Med. 2019 Jan;26(1):41-50. doi: 10.1111/acem.13504. Epub 2018 Jul 19.
PubMed 29920834Stopyra JP, Harper WS, Higgins TJ, Prokesova JV, Winslow JE, Nelson RD, Alson RL, Davis CA, Russell GB, Miller CD, Mahler SA. Prehospital Modified HEART Score Predictive of 30-Day Adverse Cardiac Events. Prehosp Disaster Med. 2018 Feb;33(1):58-62. doi: 10.1017/S1049023X17007154. Epub 2018 Jan 10.
PubMed 29316995Stopyra JP, Snavely AC, Scheidler JF, Smith LM, Nelson RD, Winslow JE, Pomper GJ, Ashburn NP, Hendley NW, Riley RF, Koehler LE, Miller CD, Mahler SA. Point-of-Care Troponin Testing during Ambulance Transport to Detect Acute Myocardial Infarction. Prehosp Emerg Care. 2020 Nov-Dec;24(6):751-759. doi: 10.1080/10903127.2020.1721740. Epub 2020 Mar 3.
PubMed 31985326Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013 Dec 1;8:139. doi: 10.1186/1748-5908-8-139.
PubMed 24289295
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Rural Health Via Cardiovascular Telehealth for Rural Patients (E-VICTORS) Project
- ClinicalTrials.gov ID
- NCT04617834
- Acronym / sponsor ID
- E-VICTORS / IRB00068612
- Conditions
- Cardiovascular Diseases, Acute Coronary Syndrome
- Keywords
- acute chest pain, telehealth, implementation science, rural health
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Nov 2020 (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.
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.
Detailed description
This program aims to improve cardiovascular care for patients in Wilkes County by implementing a cardiovascular telehealth program designed to; a) assist WC- EMS paramedics with the early risk stratification (electrocardiogram (EKG) interpretation, vital signs, and risk scores), treatment, and transportation destination decisions in patients with acute chest pain or dyspnea, b) support Wilkes Medical Center (WMC) Emergency Department (ED) providers (physicians and advanced practice clinicians) in the evaluation, management, and disposition of patients with acute cardiovascular symptoms, and c) provide consultative expertise to the Primary Health Care Centers (PHCC) for patients seen following an EMS or ED encounter for cardiovascular symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality Surveillance Data | – | Other: Quality Surveillance Data CollectionFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- age > 18 years at time of index encounter
- Cardiovascular symptoms (chest discomfort or dyspnea consistent with possible ACS) as indicated by the treating provider
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Quality Surveillance Data CollectionData will be retrospectively collected through EHR queries | Other | Quality Surveillance Data |
Primary outcome
Number of Emergency Department (ED) utilization
Time frame: baseline
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.
11 secondary outcomes
Number of Cardiovascular hospitalizations
Time frame: Baseline
Number of Cardiovascular Inter-facility transfers
Time frame: Baseline
Number of 30-day cardiovascular Emergency Department (ED) re-admissions
Time frame: day 30
Number of 30-day cardiovascular hospital re-admissions
Time frame: day 30
Number of Adverse Events
Time frame: day 30 and Month 12
Change in Cost - societal level
Time frame: day 30 and Month 12
Change in Cost - provider level
Time frame: day 30 and Month 12
Cost-effectiveness
Time frame: Month 12 and Month 48
Cardiovascular telehealth consultation rate
Time frame: Baseline
Cardiovascular telehealth adoption rate
Time frame: Month 12
Cardiovascular telehealth sustainability rate
Time frame: Month 24 - Month 48 post Intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 20177011Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Stafford R, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):948-54. doi: 10.1161/CIRCULATIONAHA.109.192666. No abstract available.
- Background: PubMed 23283859Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):143-52. doi: 10.1161/CIR.0b013e318282ab8f. No abstract available.
- Background: PubMed 29138292Jollis JG, Al-Khalidi HR, Roettig ML, Berger PB, Corbett CC, Doerfler SM, Fordyce CB, Henry TD, Hollowell L, Magdon-Ismail Z, Kochar A, McCarthy JJ, Monk L, O'Brien P, Rea TD, Shavadia J, Tamis-Holland J, Wilson BH, Ziada KM, Granger CB. Impact of Regionalization of ST-Segment-Elevation Myocardial Infarction Care on Treatment Times and Outcomes for Emergency Medical Services-Transported Patients Presenting to Hospitals With Percutaneous Coronary Intervention: Mission: Lifeline Accelerator-2. Circulation. 2018 Jan 23;137(4):376-387. doi: 10.1161/CIRCULATIONAHA.117.032446. Epub 2017 Nov 14.
- Background: PubMed 21029165Abrams TE, Vaughan-Sarrazin M, Kaboli PJ. Mortality and revascularization following admission for acute myocardial infarction: implication for rural veterans. J Rural Health. 2010 Fall;26(4):310-7. doi: 10.1111/j.1748-0361.2010.00318.x. Epub 2010 Aug 17.
- Background: PubMed 20516415Lambert L, Brown K, Segal E, Brophy J, Rodes-Cabau J, Bogaty P. Association between timeliness of reperfusion therapy and clinical outcomes in ST-elevation myocardial infarction. JAMA. 2010 Jun 2;303(21):2148-55. doi: 10.1001/jama.2010.712.
- Background: PubMed 29503284James CV, Moonesinghe R, Wilson-Frederick SM, Hall JE, Penman-Aguilar A, Bouye K. Racial/Ethnic Health Disparities Among Rural Adults-United States, 2012-2015: MMWR Surveillance Summaries / November 17, 2017 / 66(23);1-9. J Health Care Poor Underserved. 2018;29(1):19-34. doi: 10.1353/hpu.2018.0003.
- Background: PubMed 23299937O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013 Jul 1;82(1):E1-27. doi: 10.1002/ccd.24776. Epub 2013 Jan 8. No abstract available.
- Background: PubMed 32078375Harrington RA, Califf RM, Balamurugan A, Brown N, Benjamin RM, Braund WE, Hipp J, Konig M, Sanchez E, Joynt Maddox KE. Call to Action: Rural Health: A Presidential Advisory From the American Heart Association and American Stroke Association. Circulation. 2020 Mar 10;141(10):e615-e644. doi: 10.1161/CIR.0000000000000753. Epub 2020 Feb 10.
- Background: PubMed 21989033Mahler SA, Hiestand BC, Goff DC Jr, Hoekstra JW, Miller CD. Can the HEART score safely reduce stress testing and cardiac imaging in patients at low risk for major adverse cardiac events? Crit Pathw Cardiol. 2011 Sep;10(3):128-33. doi: 10.1097/HPC.0b013e3182315a85.
- Background: PubMed 25737484Mahler SA, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD. The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):195-203. doi: 10.1161/CIRCOUTCOMES.114.001384. Epub 2015 Mar 3.
- Background: PubMed 30571347Mahler SA, Lenoir KM, Wells BJ, Burke GL, Duncan PW, Case LD, Herrington DM, Diaz-Garelli JF, Futrell WM, Hiestand BC, Miller CD. Safely Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge. Circulation. 2018 Nov 27;138(22):2456-2468. doi: 10.1161/CIRCULATIONAHA.118.036528.
- Background: PubMed 29920834Stopyra JP, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD, Mahler SA. The HEART Pathway Randomized Controlled Trial One-year Outcomes. Acad Emerg Med. 2019 Jan;26(1):41-50. doi: 10.1111/acem.13504. Epub 2018 Jul 19.
- CMS Rural Health Strategy, Accessed 8/27/2018Link provided by the sponsor.
- HPSA FindLink provided by the sponsor.
- MUA FindLink provided by the sponsor.
- Medicare Fee-For-Service PaymentLink provided by the sponsor.
- Health Insurance Coverage in the United States: 2018: United States Census BureauLink provided by the sponsor.
- Bureau USC. American Community Survey (ACS).Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 A Mahler, MD, MS principal investigator
Wake Forest University Health Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Acute Coronary Syndrome, run by Wake Forest University Health Sciences at 4 sites 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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Emergency Department (ED) utilization (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617834, which also lists 36 linked publications.
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 30 Jul 2026.