ST Elevation Myocardial InfarctionNCT04381260
RUral dispaRities in prehospitAL STEMI
An observational study of ST Elevation Myocardial Infarction and Cardiovascular Diseases, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Rural Americans are more likely to be unhealthy, older, living in poverty, uninsured, and medically underserved. The CDC has made achieving health equity and improving cardiovascular health for rural Americans one of their Healthy People 2020 overarching goals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Cardiovascular Diseases
- What is being tested?
- Interview and Survey
- How many people
- 473 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 2 Jun 2022
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Registry: Patients included in the registry data will be an all-comers population of patients suffering from STEMI and transported to a primary PCI by one of 14 identified rural EMS agencies between 2016-2019. Key Informant Interviews: Participants will be EMS Directors, EMS Medical Directors, EMS Training Officers, Paramedics or EMT Crew Partners at the highest and lowest performing rural EMS agencies as determined by the STEMI registry data. Stakeholder Surveys: Survey respondents will be EMS Directors, EMS Medical Directors, EMS Training Officers, Paramedics or EMT Crew Partners at any of the 14 local EMS agencies identified as rural.
Who may be able to join
- Age ≥ 18 years
- Transported to one of four primary PCI centers (Wake Forest Baptist Medical Center (WFBMC), High Point Regional Medical Center (HPRMC), Novant Forsyth Medical Center (FMC), and Moses Cone) by rural agency (county identified rural by 2014 Census) ambulance from 2016-2019
- STEMI identified prior to or upon arrival at hospital
- Rural agency (county identified rural by 2014 Census)
- Identified as the top or bottom two performing services ranked by overall PCI time by regional STEMI registry patients transported to primary PCI center from 2016-2019
- Hold the position of EMS Director, EMS Medical Director, EMS Training Officer, Paramedic (2), EMT Crew Partner (2) or hold a similar key informant position at a local urban EMS agency (Forsyth county EMS) to allow the interview guide to be field-tested
- Rural agency (county identified rural by 2014 Census) transported to primary PCI center from 2016-2019
- Hold the position of EMS Director, EMS Medical Director, or EMS Training Officer or be a field provider with a Paramedic or EMT certification
Who cannot join
- None
- Key Informant Interviews:
- None
- Stakeholder Survey:
- None
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
Rural Americans are more likely to be unhealthy, older, living in poverty, uninsured, and medically underserved. The CDC has made achieving health equity and improving cardiovascular health for rural Americans one of their Healthy People 2020 overarching goals. ST-Elevation Myocardial Infarction (STEMI) is a life-threatening cardiovascular emergency that frequently affects people without warning within the communities the Participants live and work. Patients with STEMI have a linear relationship between first medical contact to Percutaneous Coronary Intervention (PCI) time and mortality. Delays are particularly important in STEMI patients with cardiogenic shock, who experience an excess 3.3 deaths per 100 for every 10 minute delay to PCI (for PCI times between 60-180 minutes). Delayed PCI is also associated with a higher rate of long term morbidity, including congestive heart failure and repeat MI. Unfortunately, many rural EMS agencies fail to consistently achieve the recommended 90 minute PCI time goal. Rural agencies are less likely than urban/suburban agencies to meet time goals and this disparity exposes rural patients to excess morbidity and mortality. The American College of Cardiology/American Heart Association (ACC/AHA) endorse the need for prehospital strategies to reduce total ischemic time, particularly in rural settings.
Read the detailed description
Achieving PCI time goals is influenced by multiple factors, such as patient attributes, agency factors and elements of organizational Emergency Medical Services (EMS) culture. Organizational culture is defined as a set of shared values, beliefs, and assumptions within an organization that influences how people within that organization behave. Differences in organizational culture between hospitals have been associated with both cardiovascular mortality and disease-specific outcomes. Although not yet rigorously studied in the prehospital environment, it is likely that organizational culture contributes to differences in tempo and manner of completing interventions. Prehospital performance accountability and culture have been discussed by experts in EMS magazines but have never been formally studied.
EMS STEMI protocols that include direct transportation to a PCI-capable hospital and pre-hospital PCI center activation improve patient outcomes. Unsuccessful EKG transmission, delayed PCI center activation, and cardiogenic shock have been shown to negatively affect PCI time metrics and patient outcomes. The impact of PCI delays in the rural setting has not been specifically studied. In addition, there are agency-level factors, such as ambulances per capita, number of satellite stations, miles of interstate that likely affect the EMS agency's ability to achieve shorter PCI times for the STEMI patients they care for. This proposal will use mixed methods to identify previously unmeasured components of rural EMS agency organizational culture, structure, care processes, and patient environment that likely influence PCI time and patient outcomes. In addition, this project will identify best practices that can be tested as novel interventions and implemented in rural EMS agencies to improve STEMI time metrics and therefore reduce patient morbidity and mortality.
- Being tested
- No intervention, Interview, Survey
- Keywords
- cardiovascular emergency, cardiogenic shock
- Medical subject headings
- ST Elevation Myocardial Infarction, Cardiovascular Diseases, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention for patients included in this group as this is a retrospective data registry only.
InterviewOther
Key Informant Interview
SurveyOther
Stakeholder survey
| Study group | Role | What they receive |
|---|---|---|
| 2016-2019 STEMI Registry | Retrospective data will be collected to develop a well-characterized registry of patients treated from 2016-2019 by any of 14 local rural EMS agencies and transported to a facility capable of performing Percutaneous Coronary Intervention. This registry will be used to determine the time to PCI performance for each of the EMS agencies. Time will be adjusted for patient distance from a PCI center using a linear mixed model with a random effect for center and a fixed effect for distance. This process will allow qualitative methods to identify organizational culture, structure, and clinical processes that impact STEMI care from the two highest and lowest performing rural EMS agencies. (n=750) Receives: Other: No intervention | |
| Key Informant Interviews | After identifying the two highest and lowest performing rural EMS agencies in the 2016-2019 STEMI Registry, key employees from each of those agencies will be recruited to participate in semi-structured key informant interviews. The interviews will assess current clinical care, organizational culture and opportunities for improvement. (n=32) Receives: Other: Interview | |
| Stakeholder Surveys | Employees at all local EMS agencies will be invited to participate in stakeholder surveys to quantify each agency's use of the care strategies identified during Key Information Interviews. (n=240) Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the organizational culture, structure, and clinical processes of high and low performing local rural EMS agencies using qualitative methods
Aim 1 will be accomplished by developing a 2016-2019 STEMI data registry, which will be utilized to identify high- and low-performing rural EMS agencies. After identifying these agencies, Key Informants will participate in interviews designed to assess facilitators and barriers to achieving STEMI time metrics.
Measured: 1 day
Secondary outcomes (1)
Quantify the association between factors identified in Aim 1 and PCI time among rural EMS STEMI patient encounters.
Stakeholder surveys will be utilized to quantify each agency's use of factors identified in Aim 1
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start15 Dec 2020
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Enrolment
- 473 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason M Stopyra, MD, Principal investigator, Wake Forest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381260
- Sponsor's protocol ID
- IRB00064512
- Status last verified
- Mar 2024
- First submitted
- 5 May 2020
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
Stopyra JP, Miller CD, Hiestand BC, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Riley RF, Russell GB, Burke GL, Herrington D, Hoekstra JW, Mahler SA. Chest Pain Risk Stratification: A Comparison of the 2-Hour Accelerated Diagnostic Protocol (ADAPT) and the HEART Pathway. Crit Pathw Cardiol. 2016 Jun;15(2):46-9. doi: 10.1097/HPC.0000000000000072.
PubMed 27183253Stopyra JP, Miller CD, Hiestand BC, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Riley RF, Russell GB, Hoekstra JW, Mahler SA. Performance of the EDACS-accelerated Diagnostic Pathway in a Cohort of US Patients with Acute Chest Pain. Crit Pathw Cardiol. 2015 Dec;14(4):134-8. doi: 10.1097/HPC.0000000000000059.
PubMed 26569652O'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, Anderson JL, Jacobs AK, Halperin JL, Albert NM, Brindis RG, Creager MA, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Kushner FG, Ohman EM, Stevenson WG, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 Jan 29;127(4):e362-425. doi: 10.1161/CIR.0b013e3182742cf6. Epub 2012 Dec 17. No abstract available.
PubMed 23247304Armstrong PW, Boden WE. Reperfusion paradox in ST-segment elevation myocardial infarction. Ann Intern Med. 2011 Sep 20;155(6):389-91. doi: 10.7326/0003-4819-155-6-201109200-00008.
PubMed 21930857Bates ER, Nallamothu BK. Commentary: the role of percutaneous coronary intervention in ST-segment-elevation myocardial infarction. Circulation. 2008 Jul 29;118(5):567-73. doi: 10.1161/CIRCULATIONAHA.108.788620. No abstract available.
PubMed 18663104Studnek JR, Infinger A, Wilson H, Niess G, Jackson P, Swanson D. Decreased Time from 9-1-1 Call to PCI among Patients Experiencing STEMI Results in a Decreased One Year Mortality. Prehosp Emerg Care. 2018 Nov-Dec;22(6):669-675. doi: 10.1080/10903127.2018.1447621. Epub 2018 Mar 29.
PubMed 29596009Hsia RY, Shen YC. Percutaneous Coronary Intervention in the United States: Risk Factors for Untimely Access. Health Serv Res. 2016 Apr;51(2):592-609. doi: 10.1111/1475-6773.12335. Epub 2015 Jul 14.
PubMed 26174998Jollis 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 29138292Jollis JG, Mehta RH, Roettig ML, Berger PB, Babb JD, Granger CB. Reperfusion of acute myocardial infarction in North Carolina emergency departments (RACE): study design. Am Heart J. 2006 Nov;152(5):851.e1-11. doi: 10.1016/j.ahj.2006.06.036.
PubMed 17070144Jollis JG, Roettig ML, Aluko AO, Anstrom KJ, Applegate RJ, Babb JD, Berger PB, Bohle DJ, Fletcher SM, Garvey JL, Hathaway WR, Hoekstra JW, Kelly RV, Maddox WT Jr, Shiber JR, Valeri FS, Watling BA, Wilson BH, Granger CB; Reperfusion of Acute Myocardial Infarction in North Carolina Emergency Departments (RACE) Investigators. Implementation of a statewide system for coronary reperfusion for ST-segment elevation myocardial infarction. JAMA. 2007 Nov 28;298(20):2371-80. doi: 10.1001/jama.298.20.joc70124. Epub 2007 Nov 4.
PubMed 17982184Kragholm K, Lu D, Chiswell K, Al-Khalidi HR, Roettig ML, Roe M, Jollis J, Granger CB. Improvement in Care and Outcomes for Emergency Medical Service-Transported Patients With ST-Elevation Myocardial Infarction (STEMI) With and Without Prehospital Cardiac Arrest: A Mission: Lifeline STEMI Accelerator Study. J Am Heart Assoc. 2017 Oct 11;6(10):e005717. doi: 10.1161/JAHA.117.005717.
PubMed 29021273Jollis JG, Al-Khalidi HR, Roettig ML, Berger PB, Corbett CC, Dauerman HL, Fordyce CB, Fox K, Garvey JL, Gregory T, Henry TD, Rokos IC, Sherwood MW, Suter RE, Wilson BH, Granger CB; Mission: Lifeline STEMI Systems Accelerator Project. Regional Systems of Care Demonstration Project: American Heart Association Mission: Lifeline STEMI Systems Accelerator. Circulation. 2016 Aug 2;134(5):365-74. doi: 10.1161/CIRCULATIONAHA.115.019474.
PubMed 27482000Bagai A, Al-Khalidi HR, Sherwood MW, Munoz D, Roettig ML, Jollis JG, Granger CB. Regional systems of care demonstration project: Mission: Lifeline STEMI Systems Accelerator: design and methodology. Am Heart J. 2014 Jan;167(1):15-21.e3. doi: 10.1016/j.ahj.2013.10.005. Epub 2013 Oct 23.
PubMed 24332137Steinberg BA, Jollis JG, Winkler A, Granger C, Newby LK. Treatment pathways and quality improvement for patients with acute myocardial infarction at a tertiary care center. Crit Pathw Cardiol. 2012 Jun;11(2):77-80. doi: 10.1097/HPC.0b013e318252990c.
PubMed 22595818Fordyce CB, Al-Khalidi HR, Jollis JG, Roettig ML, Gu J, Bagai A, Berger PB, Corbett CC, Dauerman HL, Fox K, Garvey JL, Henry TD, Rokos IC, Sherwood MW, Wilson BH, Granger CB; STEMI Systems Accelerator Project. Association of Rapid Care Process Implementation on Reperfusion Times Across Multiple ST-Segment-Elevation Myocardial Infarction Networks. Circ Cardiovasc Interv. 2017 Jan;10(1):e004061. doi: 10.1161/CIRCINTERVENTIONS.116.004061.
PubMed 28082714
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RUral dispaRities in prehospitAL STEMI
- ClinicalTrials.gov ID
- NCT04381260
- Acronym / sponsor ID
- IRB00064512
- Keywords
- cardiovascular emergency, cardiogenic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 8 May 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.
Rural Americans are more likely to be unhealthy, older, living in poverty, uninsured, and medically underserved. The CDC has made achieving health equity and improving cardiovascular health for rural Americans one of their Healthy People 2020 overarching goals. ST-Elevation Myocardial Infarction (STEMI) is a life-threatening cardiovascular emergency that frequently affects people without warning within the communities the Participants live and work. Patients with STEMI have a linear relationship between first medical contact to Percutaneous Coronary Intervention (PCI) time and mortality. Delays are particularly important in STEMI patients with cardiogenic shock, who experience an excess 3.3 deaths per 100 for every 10 minute delay to PCI (for PCI times between 60-180 minutes). Delayed PCI is also associated with a higher rate of long term morbidity, including congestive heart failure and repeat MI. Unfortunately, many rural EMS agencies fail to consistently achieve the recommended 90 minute PCI time goal. Rural agencies are less likely than urban/suburban agencies to meet time goals and this disparity exposes rural patients to excess morbidity and mortality. The American College of Cardiology/American Heart Association (ACC/AHA) endorse the need for prehospital strategies to reduce total ischemic time, particularly in rural settings.
Detailed description
Achieving PCI time goals is influenced by multiple factors, such as patient attributes, agency factors and elements of organizational Emergency Medical Services (EMS) culture. Organizational culture is defined as a set of shared values, beliefs, and assumptions within an organization that influences how people within that organization behave. Differences in organizational culture between hospitals have been associated with both cardiovascular mortality and disease-specific outcomes. Although not yet rigorously studied in the prehospital environment, it is likely that organizational culture contributes to differences in tempo and manner of completing interventions. Prehospital performance accountability and culture have been discussed by experts in EMS magazines but have never been formally studied.
EMS STEMI protocols that include direct transportation to a PCI-capable hospital and pre-hospital PCI center activation improve patient outcomes. Unsuccessful EKG transmission, delayed PCI center activation, and cardiogenic shock have been shown to negatively affect PCI time metrics and patient outcomes. The impact of PCI delays in the rural setting has not been specifically studied. In addition, there are agency-level factors, such as ambulances per capita, number of satellite stations, miles of interstate that likely affect the EMS agency's ability to achieve shorter PCI times for the STEMI patients they care for. This proposal will use mixed methods to identify previously unmeasured components of rural EMS agency organizational culture, structure, care processes, and patient environment that likely influence PCI time and patient outcomes. In addition, this project will identify best practices that can be tested as novel interventions and implemented in rural EMS agencies to improve STEMI time metrics and therefore reduce patient morbidity and mortality.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2016-2019 STEMI Registry | – | Other: No interventionRetrospective data will be collected to develop a well-characterized registry of patients treated from 2016-2019 by any of 14 local rural EMS agencies and transported to a facility capable of performing Percutaneous Coronary Intervention. This registry will be used to determine the time to PCI performance for each of the EMS agencies. Time will be adjusted for patient distance from a PCI center using a linear mixed model with a random effect for center and a fixed effect for distance. This process will allow qualitative methods to identify organizational culture, structure, and clinical processes that impact STEMI care from the two highest and lowest performing rural EMS agencies. (n=750) |
| Key Informant Interviews | – | Other: InterviewAfter identifying the two highest and lowest performing rural EMS agencies in the 2016-2019 STEMI Registry, key employees from each of those agencies will be recruited to participate in semi-structured key informant interviews. The interviews will assess current clinical care, organizational culture and opportunities for improvement. (n=32) |
| Stakeholder Surveys | – | Other: SurveyEmployees at all local EMS agencies will be invited to participate in stakeholder surveys to quantify each agency's use of the care strategies identified during Key Information Interviews. (n=240) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Registry: Patients included in the registry data will be an all-comers population of patients suffering from STEMI and transported to a primary PCI by one of 14 identified rural EMS agencies between 2016-2019. Key Informant Interviews: Participants will be EMS Directors, EMS Medical Directors, EMS Training Officers, Paramedics or EMT Crew Partners at the highest and lowest performing rural EMS agencies as determined by the STEMI registry data. Stakeholder Surveys: Survey respondents will be EMS Directors, EMS Medical Directors, EMS Training Officers, Paramedics or EMT Crew Partners at any of the 14 local EMS agencies identified as rural.
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Transported to one of four primary PCI centers (Wake Forest Baptist Medical Center (WFBMC), High Point Regional Medical Center (HPRMC), Novant Forsyth Medical Center (FMC), and Moses Cone) by rural agency (county identified rural by 2014 Census) ambulance from 2016-2019
- STEMI identified prior to or upon arrival at hospital
- Rural agency (county identified rural by 2014 Census)
- Identified as the top or bottom two performing services ranked by overall PCI time by regional STEMI registry patients transported to primary PCI center from 2016-2019
Key exclusion criteria (5 listed)
- None
- None
- None
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 |
|---|---|---|
| No interventionThere is no intervention for patients included in this group as this is a retrospective data registry only. | Other | 2016-2019 STEMI Registry |
| InterviewKey Informant Interview | Other | Key Informant Interviews |
| SurveyStakeholder survey | Other | Stakeholder Surveys |
Primary outcome
Compare the organizational culture, structure, and clinical processes of high and low performing local rural EMS agencies using qualitative methods
Time frame: 1 day
Aim 1 will be accomplished by developing a 2016-2019 STEMI data registry, which will be utilized to identify high- and low-performing rural EMS agencies. After identifying these agencies, Key Informants will participate in interviews designed to assess facilitators and barriers to achieving STEMI time metrics.
1 secondary outcome
Quantify the association between factors identified in Aim 1 and PCI time among rural EMS STEMI patient encounters.
Time frame: 1 day
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 27 Mar 2024.
- Background: PubMed 27183253Stopyra JP, Miller CD, Hiestand BC, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Riley RF, Russell GB, Burke GL, Herrington D, Hoekstra JW, Mahler SA. Chest Pain Risk Stratification: A Comparison of the 2-Hour Accelerated Diagnostic Protocol (ADAPT) and the HEART Pathway. Crit Pathw Cardiol. 2016 Jun;15(2):46-9. doi: 10.1097/HPC.0000000000000072.
- Background: PubMed 26569652Stopyra JP, Miller CD, Hiestand BC, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Riley RF, Russell GB, Hoekstra JW, Mahler SA. Performance of the EDACS-accelerated Diagnostic Pathway in a Cohort of US Patients with Acute Chest Pain. Crit Pathw Cardiol. 2015 Dec;14(4):134-8. doi: 10.1097/HPC.0000000000000059.
- Background: PubMed 23247304O'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, Anderson JL, Jacobs AK, Halperin JL, Albert NM, Brindis RG, Creager MA, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Kushner FG, Ohman EM, Stevenson WG, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 Jan 29;127(4):e362-425. doi: 10.1161/CIR.0b013e3182742cf6. Epub 2012 Dec 17. No abstract available.
- Background: PubMed 21930857Armstrong PW, Boden WE. Reperfusion paradox in ST-segment elevation myocardial infarction. Ann Intern Med. 2011 Sep 20;155(6):389-91. doi: 10.7326/0003-4819-155-6-201109200-00008.
- Background: PubMed 18663104Bates ER, Nallamothu BK. Commentary: the role of percutaneous coronary intervention in ST-segment-elevation myocardial infarction. Circulation. 2008 Jul 29;118(5):567-73. doi: 10.1161/CIRCULATIONAHA.108.788620. No abstract available.
- Background: PubMed 29596009Studnek JR, Infinger A, Wilson H, Niess G, Jackson P, Swanson D. Decreased Time from 9-1-1 Call to PCI among Patients Experiencing STEMI Results in a Decreased One Year Mortality. Prehosp Emerg Care. 2018 Nov-Dec;22(6):669-675. doi: 10.1080/10903127.2018.1447621. Epub 2018 Mar 29.
- Background: PubMed 26174998Hsia RY, Shen YC. Percutaneous Coronary Intervention in the United States: Risk Factors for Untimely Access. Health Serv Res. 2016 Apr;51(2):592-609. doi: 10.1111/1475-6773.12335. Epub 2015 Jul 14.
- 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 17070144Jollis JG, Mehta RH, Roettig ML, Berger PB, Babb JD, Granger CB. Reperfusion of acute myocardial infarction in North Carolina emergency departments (RACE): study design. Am Heart J. 2006 Nov;152(5):851.e1-11. doi: 10.1016/j.ahj.2006.06.036.
- Background: PubMed 17982184Jollis JG, Roettig ML, Aluko AO, Anstrom KJ, Applegate RJ, Babb JD, Berger PB, Bohle DJ, Fletcher SM, Garvey JL, Hathaway WR, Hoekstra JW, Kelly RV, Maddox WT Jr, Shiber JR, Valeri FS, Watling BA, Wilson BH, Granger CB; Reperfusion of Acute Myocardial Infarction in North Carolina Emergency Departments (RACE) Investigators. Implementation of a statewide system for coronary reperfusion for ST-segment elevation myocardial infarction. JAMA. 2007 Nov 28;298(20):2371-80. doi: 10.1001/jama.298.20.joc70124. Epub 2007 Nov 4.
- Background: PubMed 29021273Kragholm K, Lu D, Chiswell K, Al-Khalidi HR, Roettig ML, Roe M, Jollis J, Granger CB. Improvement in Care and Outcomes for Emergency Medical Service-Transported Patients With ST-Elevation Myocardial Infarction (STEMI) With and Without Prehospital Cardiac Arrest: A Mission: Lifeline STEMI Accelerator Study. J Am Heart Assoc. 2017 Oct 11;6(10):e005717. doi: 10.1161/JAHA.117.005717.
- Background: PubMed 27482000Jollis JG, Al-Khalidi HR, Roettig ML, Berger PB, Corbett CC, Dauerman HL, Fordyce CB, Fox K, Garvey JL, Gregory T, Henry TD, Rokos IC, Sherwood MW, Suter RE, Wilson BH, Granger CB; Mission: Lifeline STEMI Systems Accelerator Project. Regional Systems of Care Demonstration Project: American Heart Association Mission: Lifeline STEMI Systems Accelerator. Circulation. 2016 Aug 2;134(5):365-74. doi: 10.1161/CIRCULATIONAHA.115.019474.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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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.
Jason M Stopyra, MD principal investigator
Wake Forest 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 ST Elevation Myocardial Infarction and Cardiovascular Diseases, 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 8 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: finished, as of the sponsor's last update on 27 Mar 2024. 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?
Compare the organizational culture, structure, and clinical processes of high and low performing local rural EMS agencies using qualitative methods (time frame: 1 day). 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 NCT04381260, which also lists 57 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 27 Mar 2024.