Acute Coronary SyndromePARA-HEARTNCT02709135
PARA-HEART Pilot Implementation
An observational study of Acute Coronary Syndrome and Chest Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. These patients are a challenge to healthcare providers, who are tasked with determining whether these symptoms are due to an acute coronary syndrome (ACS) or a non-ACS cause.In an effort… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Chest Pain
- How many people
- 511 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 30 Aug 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with symptoms concerning for acute coronary syndrome who are being transported to the Wake Forest Baptist Medical Center Emergency Department by paramedics trained to complete a HEART Score and POC troponin assessment will be eligible for inclusion in this quality surveillance study.
Who may be able to join
- age greater than or equal to 21 years
- Non-traumatic chest discomfort or other symptoms consistent with possible
- Patient being transported to Wake Forest Baptist Health ED for further care
Who cannot join
- ST-segment elevation in contiguous leads on any electrocardiogram
- Inter-facility transfers
- Short Pre-hospital times: anticipated scene + transportation time less than 5 mins
- Unstable vitals signs
- Known terminal diagnosis with life expectancy less than 1 year
- Concomitant non-cardiac medical, surgical, or psychiatric emergency
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School Of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Can Pre-Hospital Use of the HEART Score and Abbott i-STAT® Point-of-Care Troponin Predict Major Adverse Cardiovascular Events: the PARA-HEART Pilot Implementation
Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. These patients are a challenge to healthcare providers, who are tasked with determining whether these symptoms are due to an acute coronary syndrome (ACS) or a non-ACS cause.In an effort to improve the quality and value of care for patients with acute chest pain, our group recently validated a risk stratification pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on higher-risk patients, who are more likely to benefit from testing.While the HEART score has been well validated in the ED setting, it has yet to be implemented in a prehospital setting. Paramedics are often the first providers to evaluate and begin treating patients with symptoms concerning for ACS. Current pre-hospital risk stratification is largely based on a combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI (ST-segment elevation myocardial infarction) are poor predictors of ACS, paramedics often have difficulty distinguishing high-risk patients from low-risk patients.Thus, multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT® point-of-care (POC) troponin testing in the prehospital setting is needed. To establish the feasibility and accuracy of HEART score and POC testing in the prehospital setting the investigators propose a quality surveillance study of a limited implementation of the HEART score with POC troponin testing.
Read the detailed description
Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. These patients are a challenge to healthcare providers, who are tasked with determining whether these symptoms are due to an acute coronary syndrome (ACS) or a non-ACS cause. Missing the diagnosis of ACS is associated with high rates of morbidity, mortality, and malpractice claims. Therefore, to avoid missing the diagnosis of ACS, patients with chest pain typically undergo extensive evaluations at an estimated cost of $10-13 billion annually. However, less than 10% of these patients are ultimately diagnosed with ACS. As the US healthcare system shifts towards a value-based model, it is clear that the current care patterns for acute chest pain, which fail to focus health system resources, such as hospitalization and cardiac testing, on patients most likely to benefit, are not sustainable.
In an effort to improve the quality and value of care for patients with acute chest pain, our group recently validated a risk stratification pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on higher-risk patients, who are more likely to benefit from testing. The HEART Pathway, which utilizes an easy to use clinical decision aid (the HEART score) and serial troponin measurement, has been shown to significantly reduce objective cardiac testing (stress testing and coronary angiography), shorten hospital length of stay, and increase the early discharge rate from the Emergency Department among patients with acute chest pain. These important efficiency gains occur without missing ACS and without increasing return visits to the ED or downstream admissions to the hospital over a 30 day period.
While the HEART score has been well validated in the ED setting, it has yet to be implemented in a prehospital setting. Paramedics are often the first providers to evaluate and begin treating patients with symptoms concerning for ACS. Current pre-hospital risk stratification is largely based on a combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI are poor predictors of ACS, paramedics often have difficulty distinguishing high-risk patients from low-risk patients. Therefore, integrating objective risk stratification tools, such as the HEART score and point-of-care troponin testing, into Emergency Medical Services (EMS) triage and destination plans represents an opportunity to improve care. Furthermore, expanding use of the HEART score to paramedics in the pre-hospital setting is a natural extension of our prior work, especially given the growing sophistication of mobile integrated healthcare ("community paramedicine") over the last decade. Thus, multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT® point-of-care (POC) troponin testing in the prehospital setting is needed.
The investigators anticipate that a standardized approach to paramedic risk stratification using the HEART score with Abbott's i-STAT® POC troponin testing will be feasible and achieve high accuracy for the detection of ACS. Ultimately the investigators believe this planned implementation will improve the quality and value of chest pain care. Placing these tools in the hands of our first responders will identify patients with ACS earlier and speed the delivery of potentially life-saving care. For example, EMS triage and destination plans (chest pain treatment and transportation triage and destination plans) could be amended so that patients with positive POC troponins or high HEART scores could be transported directly to a hospital with cardiac catheterization capabilities, avoiding delays and costs associated with inter-facility transfers. However, before EMS triage and destination plans can fully incorporate the HEART score and POC troponin testing, first the feasibility of such an implementation must be established by collecting quality surveillance data.
To establish the feasibility and accuracy of HEART score and POC testing in the prehospital setting the investigators propose a quality surveillance study of a limited implementation of the HEART score with POC troponin testing. This pilot will include paramedics from three demographically distinct counties (Forsyth, Surry, and Stokes counties) in North Carolina, who will begin using the HEART score and i-STAT POC Troponin as part of their risk assessment for patients with acute chest pain. However, EMS triage and transportation plans will not be altered based on the HEART score assessment until feasibility and accuracy have been established. To ensure the feasibility and accuracy of paramedic chest pain risk assessment the investigators will be performing surveillance of electronic health records (EHR) and contacting patients by phone (which is a common practice in EMS quality assurance). Quality surveillance participants (n=500) will be identified retrospectively and quality assurance data will be collected electronically using EHR (EMS records, and Wake Forest Baptist Health health records) and via telephone follow-up calls (which are customary in EMS quality assurance projects).
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-hospital HEART Score | All subjects included in this quality surveillance study will have had a HEART score, including POC troponin calculated by paramedics prior to arrival at the emergency department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE) at 30 days
The primary outcome is MACE at 30 days. MACE is a composite outcome of cardiac death, acute myocardial infarction, and coronary revascularization.
Measured: 30 Days
Secondary outcomes (4)
Rate of objective cardiac testing
Objective cardiac testing will be defined by any stress testing modality, coronary computed tomography (CT) angiography, or invasive coronary angiography.
Measured: 30 Days
Length of Stay
Length of stay (LOS) will be the time from ED arrival to hospital discharge for all patients, whether admitted or not.
Measured: 30 Days
Rate of hospitalization at index
Index visit hospitalization will be defined as an inpatient or observation admission (including Observation Unit evaluations with stress testing or cardiac imaging).
Measured: 30 Days
Rate of cardiac related hospital admissions and ED visits during follow-up
Hospital admissions and ED visits occurring during the 30 day follow up period will be categorized as cardiac-related if a cardiac procedure is performed, the primary reason for admission/visit is chest pain, possible ACS, or a discharge diagnosis relates to chest pain, myocardial infarction (MI), acute coronary syndrome, heart failure, dysrhythmias, pericardial disease, or other cardiac disease. Cardiac procedures include cardiac imaging / stress testing (excluding resting echo), coronary revascularization, and pacemaker or defibrillator insertion.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startDec 2016
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Mahler, MD, MS, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709135
- Sponsor's protocol ID
- IRB00036229
- Acronym
- PARA-HEART
- Status last verified
- Sep 2018
- First submitted
- 3 Mar 2016
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.
PubMed 18086926McCaig LF, Nawar EW. National Hospital Ambulatory Medical Care Survey: 2004 emergency department summary. Adv Data. 2006 Jun 23;(372):1-29.
PubMed 16841785Owens PL, Barrett ML, Gibson TB, Andrews RM, Weinick RM, Mutter RL. Emergency department care in the United States: a profile of national data sources. Ann Emerg Med. 2010 Aug;56(2):150-65. doi: 10.1016/j.annemergmed.2009.11.022. Epub 2010 Jan 15.
PubMed 20074834Pope JH, Aufderheide TP, Ruthazer R, Woolard RH, Feldman JA, Beshansky JR, Griffith JL, Selker HP. Missed diagnoses of acute cardiac ischemia in the emergency department. N Engl J Med. 2000 Apr 20;342(16):1163-70. doi: 10.1056/NEJM200004203421603.
PubMed 10770981Pines JM, Isserman JA, Szyld D, Dean AJ, McCusker CM, Hollander JE. The effect of physician risk tolerance and the presence of an observation unit on decision making for ED patients with chest pain. Am J Emerg Med. 2010 Sep;28(7):771-9. doi: 10.1016/j.ajem.2009.03.019. Epub 2010 Feb 25.
PubMed 20837253Fleischmann KE, Goldman L, Johnson PA, Krasuski RA, Bohan JS, Hartley LH, Lee TH. Critical pathways for patients with acute chest pain at low risk. J Thromb Thrombolysis. 2002 Apr;13(2):89-96. doi: 10.1023/a:1016246814235.
PubMed 12101386Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.
PubMed 21160056Goldstein JA, Gallagher MJ, O'Neill WW, Ross MA, O'Neil BJ, Raff GL. A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain. J Am Coll Cardiol. 2007 Feb 27;49(8):863-71. doi: 10.1016/j.jacc.2006.08.064. Epub 2007 Feb 12.
PubMed 17320744Farkouh ME, Smars PA, Reeder GS, Zinsmeister AR, Evans RW, Meloy TD, Kopecky SL, Allen M, Allison TG, Gibbons RJ, Gabriel SE. A clinical trial of a chest-pain observation unit for patients with unstable angina. Chest Pain Evaluation in the Emergency Room (CHEER) Investigators. N Engl J Med. 1998 Dec 24;339(26):1882-8. doi: 10.1056/NEJM199812243392603.
PubMed 9862943Heller GV, Stowers SA, Hendel RC, Herman SD, Daher E, Ahlberg AW, Baron JM, Mendes de Leon CF, Rizzo JA, Wackers FJ. Clinical value of acute rest technetium-99m tetrofosmin tomographic myocardial perfusion imaging in patients with acute chest pain and nondiagnostic electrocardiograms. J Am Coll Cardiol. 1998 Apr;31(5):1011-7. doi: 10.1016/s0735-1097(98)00057-6.
PubMed 9562001Sprivulis PC, Da Silva JA, Jacobs IG, Frazer AR, Jelinek GA. The association between hospital overcrowding and mortality among patients admitted via Western Australian emergency departments. Med J Aust. 2006 Mar 6;184(5):208-12. doi: 10.5694/j.1326-5377.2006.tb00416.x.
PubMed 16515429Miro O, Antonio MT, Jimenez S, De Dios A, Sanchez M, Borras A, Milla J. Decreased health care quality associated with emergency department overcrowding. Eur J Emerg Med. 1999 Jun;6(2):105-7. doi: 10.1097/00063110-199906000-00003.
PubMed 10461551Six AJ, Backus BE, Kelder JC. Chest pain in the emergency room: value of the HEART score. Neth Heart J. 2008 Jun;16(6):191-6. doi: 10.1007/BF03086144.
PubMed 18665203Backus BE, Six AJ, Kelder JC, Mast TP, van den Akker F, Mast EG, Monnink SH, van Tooren RM, Doevendans PA. Chest pain in the emergency room: a multicenter validation of the HEART Score. Crit Pathw Cardiol. 2010 Sep;9(3):164-9. doi: 10.1097/HPC.0b013e3181ec36d8.
PubMed 20802272Backus BE, Six AJ, Kelder JC, Bosschaert MA, Mast EG, Mosterd A, Veldkamp RF, Wardeh AJ, Tio R, Braam R, Monnink SH, van Tooren R, Mast TP, van den Akker F, Cramer MJ, Poldervaart JM, Hoes AW, Doevendans PA. A prospective validation of the HEART score for chest pain patients at the emergency department. Int J Cardiol. 2013 Oct 3;168(3):2153-8. doi: 10.1016/j.ijcard.2013.01.255. Epub 2013 Mar 7.
PubMed 23465250
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Pre-Hospital Use of the HEART Score and Abbott i-STAT® Point-of-Care Troponin Predict Major Adverse Cardiovascular Events: the PARA-HEART Pilot Implementation
- ClinicalTrials.gov ID
- NCT02709135
- Acronym / sponsor ID
- PARA-HEART / IRB00036229
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 15 Mar 2016 (estimated)
- 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.
Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. These patients are a challenge to healthcare providers, who are tasked with determining whether these symptoms are due to an acute coronary syndrome (ACS) or a non-ACS cause.In an effort to improve the quality and value of care for patients with acute chest pain, our group recently validated a risk stratification pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on higher-risk patients, who are more likely to benefit from testing.While the HEART score has been well validated in the ED setting, it has yet to be implemented in a prehospital setting. Paramedics are often the first providers to evaluate and begin treating patients with symptoms concerning for ACS. Current pre-hospital risk stratification is largely based on a combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI (ST-segment elevation myocardial infarction) are poor predictors of ACS, paramedics often have difficulty distinguishing high-risk patients from low-risk patients.Thus, multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT® point-of-care (POC) troponin testing in the prehospital setting is needed. To establish the feasibility and accuracy of HEART score and POC testing in the prehospital setting the investigators propose a quality surveillance study of a limited implementation of the HEART score with POC troponin testing.
Detailed description
Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. These patients are a challenge to healthcare providers, who are tasked with determining whether these symptoms are due to an acute coronary syndrome (ACS) or a non-ACS cause. Missing the diagnosis of ACS is associated with high rates of morbidity, mortality, and malpractice claims. Therefore, to avoid missing the diagnosis of ACS, patients with chest pain typically undergo extensive evaluations at an estimated cost of $10-13 billion annually. However, less than 10% of these patients are ultimately diagnosed with ACS. As the US healthcare system shifts towards a value-based model, it is clear that the current care patterns for acute chest pain, which fail to focus health system resources, such as hospitalization and cardiac testing, on patients most likely to benefit, are not sustainable.
In an effort to improve the quality and value of care for patients with acute chest pain, our group recently validated a risk stratification pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on higher-risk patients, who are more likely to benefit from testing. The HEART Pathway, which utilizes an easy to use clinical decision aid (the HEART score) and serial troponin measurement, has been shown to significantly reduce objective cardiac testing (stress testing and coronary angiography), shorten hospital length of stay, and increase the early discharge rate from the Emergency Department among patients with acute chest pain. These important efficiency gains occur without missing ACS and without increasing return visits to the ED or downstream admissions to the hospital over a 30 day period.
While the HEART score has been well validated in the ED setting, it has yet to be implemented in a prehospital setting. Paramedics are often the first providers to evaluate and begin treating patients with symptoms concerning for ACS. Current pre-hospital risk stratification is largely based on a combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI are poor predictors of ACS, paramedics often have difficulty distinguishing high-risk patients from low-risk patients. Therefore, integrating objective risk stratification tools, such as the HEART score and point-of-care troponin testing, into Emergency Medical Services (EMS) triage and destination plans represents an opportunity to improve care. Furthermore, expanding use of the HEART score to paramedics in the pre-hospital setting is a natural extension of our prior work, especially given the growing sophistication of mobile integrated healthcare ("community paramedicine") over the last decade. Thus, multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT® point-of-care (POC) troponin testing in the prehospital setting is needed.
The investigators anticipate that a standardized approach to paramedic risk stratification using the HEART score with Abbott's i-STAT® POC troponin testing will be feasible and achieve high accuracy for the detection of ACS. Ultimately the investigators believe this planned implementation will improve the quality and value of chest pain care. Placing these tools in the hands of our first responders will identify patients with ACS earlier and speed the delivery of potentially life-saving care. For example, EMS triage and destination plans (chest pain treatment and transportation triage and destination plans) could be amended so that patients with positive POC troponins or high HEART scores could be transported directly to a hospital with cardiac catheterization capabilities, avoiding delays and costs associated with inter-facility transfers. However, before EMS triage and destination plans can fully incorporate the HEART score and POC troponin testing, first the feasibility of such an implementation must be established by collecting quality surveillance data.
To establish the feasibility and accuracy of HEART score and POC testing in the prehospital setting the investigators propose a quality surveillance study of a limited implementation of the HEART score with POC troponin testing. This pilot will include paramedics from three demographically distinct counties (Forsyth, Surry, and Stokes counties) in North Carolina, who will begin using the HEART score and i-STAT POC Troponin as part of their risk assessment for patients with acute chest pain. However, EMS triage and transportation plans will not be altered based on the HEART score assessment until feasibility and accuracy have been established. To ensure the feasibility and accuracy of paramedic chest pain risk assessment the investigators will be performing surveillance of electronic health records (EHR) and contacting patients by phone (which is a common practice in EMS quality assurance). Quality surveillance participants (n=500) will be identified retrospectively and quality assurance data will be collected electronically using EHR (EMS records, and Wake Forest Baptist Health health records) and via telephone follow-up calls (which are customary in EMS quality assurance projects).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-hospital HEART Score | – | –All subjects included in this quality surveillance study will have had a HEART score, including POC troponin calculated by paramedics prior to arrival at the emergency department. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with symptoms concerning for acute coronary syndrome who are being transported to the Wake Forest Baptist Medical Center Emergency Department by paramedics trained to complete a HEART Score and POC troponin assessment will be eligible for inclusion in this quality surveillance study.
Key inclusion criteria (3 listed)
- age greater than or equal to 21 years
- Non-traumatic chest discomfort or other symptoms consistent with possible
- Patient being transported to Wake Forest Baptist Health ED for further care
Key exclusion criteria (6 listed)
- ST-segment elevation in contiguous leads on any electrocardiogram
- Inter-facility transfers
- Short Pre-hospital times: anticipated scene + transportation time less than 5 mins
- Unstable vitals signs
- Known terminal diagnosis with life expectancy less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiac Events (MACE) at 30 days
Time frame: 30 Days
The primary outcome is MACE at 30 days. MACE is a composite outcome of cardiac death, acute myocardial infarction, and coronary revascularization.
4 secondary outcomes
Rate of objective cardiac testing
Time frame: 30 Days
Length of Stay
Time frame: 30 Days
Rate of hospitalization at index
Time frame: 30 Days
Rate of cardiac related hospital admissions and ED visits during follow-up
Time frame: 30 Days
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 4 Mar 2022.
- Background: PubMed 18086926Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.
- Background: PubMed 16841785McCaig LF, Nawar EW. National Hospital Ambulatory Medical Care Survey: 2004 emergency department summary. Adv Data. 2006 Jun 23;(372):1-29.
- Background: PubMed 20074834Owens PL, Barrett ML, Gibson TB, Andrews RM, Weinick RM, Mutter RL. Emergency department care in the United States: a profile of national data sources. Ann Emerg Med. 2010 Aug;56(2):150-65. doi: 10.1016/j.annemergmed.2009.11.022. Epub 2010 Jan 15.
- Background: PubMed 10770981Pope JH, Aufderheide TP, Ruthazer R, Woolard RH, Feldman JA, Beshansky JR, Griffith JL, Selker HP. Missed diagnoses of acute cardiac ischemia in the emergency department. N Engl J Med. 2000 Apr 20;342(16):1163-70. doi: 10.1056/NEJM200004203421603.
- Background: PubMed 20837253Pines JM, Isserman JA, Szyld D, Dean AJ, McCusker CM, Hollander JE. The effect of physician risk tolerance and the presence of an observation unit on decision making for ED patients with chest pain. Am J Emerg Med. 2010 Sep;28(7):771-9. doi: 10.1016/j.ajem.2009.03.019. Epub 2010 Feb 25.
- Background: PubMed 12101386Fleischmann KE, Goldman L, Johnson PA, Krasuski RA, Bohan JS, Hartley LH, Lee TH. Critical pathways for patients with acute chest pain at low risk. J Thromb Thrombolysis. 2002 Apr;13(2):89-96. doi: 10.1023/a:1016246814235.
- Background: PubMed 21160056Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.
- Background: PubMed 17320744Goldstein JA, Gallagher MJ, O'Neill WW, Ross MA, O'Neil BJ, Raff GL. A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain. J Am Coll Cardiol. 2007 Feb 27;49(8):863-71. doi: 10.1016/j.jacc.2006.08.064. Epub 2007 Feb 12.
- Background: PubMed 9862943Farkouh ME, Smars PA, Reeder GS, Zinsmeister AR, Evans RW, Meloy TD, Kopecky SL, Allen M, Allison TG, Gibbons RJ, Gabriel SE. A clinical trial of a chest-pain observation unit for patients with unstable angina. Chest Pain Evaluation in the Emergency Room (CHEER) Investigators. N Engl J Med. 1998 Dec 24;339(26):1882-8. doi: 10.1056/NEJM199812243392603.
- Background: PubMed 9562001Heller GV, Stowers SA, Hendel RC, Herman SD, Daher E, Ahlberg AW, Baron JM, Mendes de Leon CF, Rizzo JA, Wackers FJ. Clinical value of acute rest technetium-99m tetrofosmin tomographic myocardial perfusion imaging in patients with acute chest pain and nondiagnostic electrocardiograms. J Am Coll Cardiol. 1998 Apr;31(5):1011-7. doi: 10.1016/s0735-1097(98)00057-6.
- Background: PubMed 16515429Sprivulis PC, Da Silva JA, Jacobs IG, Frazer AR, Jelinek GA. The association between hospital overcrowding and mortality among patients admitted via Western Australian emergency departments. Med J Aust. 2006 Mar 6;184(5):208-12. doi: 10.5694/j.1326-5377.2006.tb00416.x.
- Background: PubMed 10461551Miro O, Antonio MT, Jimenez S, De Dios A, Sanchez M, Borras A, Milla J. Decreased health care quality associated with emergency department overcrowding. Eur J Emerg Med. 1999 Jun;6(2):105-7. doi: 10.1097/00063110-199906000-00003.
- Individual participant dataSharing planned: No
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Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Coronary Artery Disease, Coronary Disease
Active, not recruiting
Point-of-Care Troponin Testing in the Emergency Department
Acute Coronary Syndromes
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, MS principal investigator
Associate Professor
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 Acute Coronary Syndrome and Chest Pain, 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 3 inclusion and 6 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 4 Mar 2022. 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?
Major Adverse Cardiac Events (MACE) at 30 days (time frame: 30 Days). 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 NCT02709135, which also lists 26 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 4 Mar 2022.