Acute Coronary SyndromePHECG2NCT03699137
Pre-hospital ECG in Acute Coronary Syndromes
An observational study of Acute Coronary Syndrome and STEMI, run by Kingston University at 3 sites in United Kingdom.
Trial summary
The Pre-Hospital 12-lead electrocardiogram (PHECG) is a simple test that helps ambulance clinicians assess patients with suspected acute coronary syndrome (heart attack), and provides clinical data to inform ongoing care. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Acute Coronary Syndrome, STEMI, Non STEMI
- How many people
- 420,048 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 6 May 2019to 1 Apr 2020
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two types of study populations: 1. - Patients with confirmed diagnosis of ACS in MINAP database as per inclusion and exclusion criteria 2. - Emergency Medical Service personnel who have been trained to perform 12 lead ECG.
Who may be able to join
- Patients > 18 years of age
- Patients with ACS
- Patients who have been brought to hospital by Emergency Medical Service (EMS)
- Patients included in the MINAP registry
- First episode of ACS
- Patients with confirmed STEMI and NSTEMI
- EMS personnel trained in performing an ECG in the pre-hospital setting
- EMS personnel involved in care of patients with a suspected heart attack
Who cannot join
- patients < 18 years of age
- patients who self-presented at hospitals with suspected ACS
- patients who developed ACS whilst in hospital
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
West Midlands Ambulance Service
Brierley Hill, West Midlands, DY5 1LX
Welsh Ambulance Services NHS Trust
Cardiff, Wales, CF11 8PL
South Western Ambulance Service NHS Foundation Trust
Exeter, Devon, EX2 7HY
About this study
Official title: Use and Impact of the Pre-hospital 12-lead Electrocardiogram in the Primary PCI Era: Mixed Methods Study (PHECG2)
The Pre-Hospital 12-lead electrocardiogram (PHECG) is a simple test that helps ambulance clinicians assess patients with suspected acute coronary syndrome (heart attack), and provides clinical data to inform ongoing care. This project builds on previous work by this team, which found that one in three eligible patients did not receive a PHECG, but those that did had a lowered risk of short-term death. In this study the investigators will update that work, and explore reasons for variations in practice - highlighting opportunities to improve care and outcomes.
Using routinely collected data and qualitative methods, the investigators will research patient, practitioner and contextual factors contributing to the decision to administer a PHECG. The aim is also to develop an intervention to increase the proportion of eligible patients that receive a PHECG, and to produce a proposal for further funding to test this intervention in a subsequent randomised trial.
Read the detailed description
This mixed methods design study consists of four work packages:
WP1 - Population-based, linked cohort study using MINAP data from 2010-2016
This work package will entail analysis of data from around 420,000 pseudonymised patient records from the MINAP database, linking to the Office for National Statistics (ONS) in order to determine mortality/vital status. No patients will be contacted to obtain consent for inclusion of their records in the study as NICOR (custodian of MINAP data) hold section 251 exemption to hold and process patient data for clinical audit purposes without their explicit consent. The data will be released to the research team, using established processes, in pseudonymised format.
The study statisticians will analyse the data provided from MINAP to determine how many heart attack patients who came by ambulance survive to 30 days, estimate time to death, and will estimate from the data whether more people who had an ambulance ECG survive compared to those who did not have the test.
The aim of the study is also to determine from the data whether patients who have an ambulance ECG receive treatment in hospital faster than those who did not.
WP2 - Retrospective chart review of ambulance records
The study statisticians will generate from the larger sample discussed above, a smaller sample (approximately 1800 patients in total) specific to three National Health Service (NHS) ambulance services (Welsh, West Midlands and South West). The investigators will then work with those ambulance services to review the records held by the ambulance service, to see what other information over and above that is collected in the national MINAP audit (e.g. presenting symptoms, severity of any chest pain, public place or home, patient preferences including declining to have the test, ambulance clinician grade and gender). The investigators have worked with a 'task and finish group' of paramedics and cardiology experts to agree which data might be helpful and devised specific forms to collect these data. Data collection from ambulance records will be undertaken by NHS paramedics in the three ambulance services, seconded to work on this project. These paramedics will receive specific training in study procedures to ensure accuracy and data quality. Anonymised data collected by these 'research paramedics' will be sent to the research team by secure electronic database.
WP3 - Ambulance clinician self-report on PHECG recording
In this work package, clinical staff from the three participating ambulance Trusts (48 in total) will be invited to participate in focus group discussions led by an experienced researcher. A semi-structured topic guide (developed beforehand with the help and advice of a small group of paramedics and cardiac experts, and our knowledge of previous literature on paramedic decision making) will be used to explore the view of consenting ambulance clinicians about their perceptions of the role of the PHECG, their experiences of assessing patients with suspected heart attack, and factors which might influence the decision to record (or not) an ECG when assessing and treating a patient.
Focus group discussions will be audio-recorded and transcribed. A method called framework analysis will be used to analyse the transcribed records of the focus group discussions to see whether any particular themes arise, including consensus or disagreement of ambulance staff views on recording an ECG, and consider them against any differences in the characteristics of focus group participants (e.g. grade of clinician, employing ambulance service's local practice).
WP4 - Synthesis of the findings
The investigators will bring together ambulance staff, patient representatives, cardiac experts and researchers to consider the findings from the three work packages described above, with aim to synthesise the study findings and present evidence addressing the study research questions. This will be done with consideration of the investigators' work as forming the 'development phase' for the design of a complex intervention for further testing in a later study.
The project has been designed with input from patient and public representatives especially around the importance of the research question(s), potential impact of the findings for patients and the public. The study team includes three paramedics who have been instrumental in the design of the study as well as supporting documentation particularly for WP3.
- Conditions
- Acute Coronary Syndrome, STEMI, Non STEMI
- Being tested
- No interventions
- Keywords
- Acute coronary syndrome, Emergency Medical Services, Electrocardiogram, Outcomes
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| Cases with confirmed ACS | Cases with confirmed diagnosis of acute coronary syndrome in the MINAP database (national registry of ACS patients). No interventions apply to this group as this is an observational study. Receives: Other: No interventions | |
| EMS personnel | Emergency Medical Service (EMS) personnel will take part in the focus group. No intervention applies to this group in this qualitative component of the study. Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
WP1: 30-day mortality
Proportion of patients who die within 30 days of the date of their event
Measured: 30 days
Secondary outcomes (6)
Time to death
Length of time in days from ACS event to death
Measured: Up to one year
Hospital mortality
Proportion of patients in each group who die during the (initial) hospital stay following their event
Measured: Up to 90 days
One year mortality
Proportion of patients in each group who die within one year of their ACS event.
Measured: One year
Time under care of EMS
Length of time from EMS arrival on scene to patient arrives at hospital.
Measured: Up to 3 hours
Use and type of reperfusion
Proportion of patients with STEMI who receive reperfusion treatment (pPCI or fibrinolytic).
Measured: 24 hours
Time to treatment
Time in minutes from initial EMS call to patients first recorded reperfusion treatment.(STEMI only)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start6 May 2019
- Primary completion31 Dec 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)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
- Other
- Time perspective
- Retrospective
- Enrolment
- 420,048 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kingston University
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University, University of Leeds, London Ambulance Service, West Midlands Ambulance Service NHS Foundation Trust, South West Ambulance Service NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Tom Quinn, FESC FAHA FACC, Principal investigator, Kingston University & St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699137
- Sponsor's protocol ID
- ECCCR_PHECG2
- Acronym
- PHECG2
- Status last verified
- Apr 2020
- First submitted
- 18 Sep 2018
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Welsford M, Nikolaou NI, Beygui F, Bossaert L, Ghaemmaghami C, Nonogi H, O'Connor RE, Pichel DR, Scott T, Walters DL, Woolfrey KG; Acute Coronary Syndrome Chapter Collaborators. Part 5: Acute Coronary Syndromes: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S146-76. doi: 10.1161/CIR.0000000000000274. No abstract available.
PubMed 26472852O'Connor RE, Al Ali AS, Brady WJ, Ghaemmaghami CA, Menon V, Welsford M, Shuster M. Part 9: Acute Coronary Syndromes: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S483-500. doi: 10.1161/CIR.0000000000000263. No abstract available.
PubMed 26472997Nikolaou NI, Arntz HR, Bellou A, Beygui F, Bossaert LL, Cariou A; Initial management of acute coronary syndromes section Collaborator. European Resuscitation Council Guidelines for Resuscitation 2015 Section 8. Initial management of acute coronary syndromes. Resuscitation. 2015 Oct;95:264-77. doi: 10.1016/j.resuscitation.2015.07.030. Epub 2015 Oct 15. No abstract available.
PubMed 26477416Tubaro M, Danchin N, Goldstein P, Filippatos G, Hasin Y, Heras M, Jansky P, Norekval TM, Swahn E, Thygesen K, Vrints C, Zahger D, Arntz HR, Bellou A, De La Coussaye JE, De Luca L, Huber K, Lambert Y, Lettino M, Lindahl B, McLean S, Nibbe L, Peacock WF, Price S, Quinn T, Spaulding C, Tatu-Chitoiu G, Van De Werf F. Pre-hospital treatment of STEMI patients. A scientific statement of the Working Group Acute Cardiac Care of the European Society of Cardiology. Acute Card Care. 2011 Jun;13(2):56-67. doi: 10.3109/17482941.2011.581292.
PubMed 21627394Quinn T, Johnsen S, Gale CP, Snooks H, McLean S, Woollard M, Weston C; Myocardial Ischaemia National Audit Project (MINAP) Steering Group. Effects of prehospital 12-lead ECG on processes of care and mortality in acute coronary syndrome: a linked cohort study from the Myocardial Ischaemia National Audit Project. Heart. 2014 Jun;100(12):944-50. doi: 10.1136/heartjnl-2013-304599. Epub 2014 Apr 14.
PubMed 24732676Curtis JP, Portnay EL, Wang Y, McNamara RL, Herrin J, Bradley EH, Magid DJ, Blaney ME, Canto JG, Krumholz HM; National Registry of Myocardial Infarction-4. The pre-hospital electrocardiogram and time to reperfusion in patients with acute myocardial infarction, 2000-2002: findings from the National Registry of Myocardial Infarction-4. J Am Coll Cardiol. 2006 Apr 18;47(8):1544-52. doi: 10.1016/j.jacc.2005.10.077. Epub 2006 Mar 29.
PubMed 16630989Diercks DB, Kontos MC, Chen AY, Pollack CV Jr, Wiviott SD, Rumsfeld JS, Magid DJ, Gibler WB, Cannon CP, Peterson ED, Roe MT. Utilization and impact of pre-hospital electrocardiograms for patients with acute ST-segment elevation myocardial infarction: data from the NCDR (National Cardiovascular Data Registry) ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry. J Am Coll Cardiol. 2009 Jan 13;53(2):161-6. doi: 10.1016/j.jacc.2008.09.030.
PubMed 19130984Ducas RA, Labos C, Allen D, Golian M, Jeyaraman M, Lys J, Mann A, Copstein L, Vokey S, Rabbani R, Zarychanski R, Abou-Setta AM, Menkis AH. Association of Pre-hospital ECG Administration With Clinical Outcomes in ST-Segment Myocardial Infarction: A Systematic Review and Meta-analysis. Can J Cardiol. 2016 Dec;32(12):1531-1541. doi: 10.1016/j.cjca.2016.06.004. Epub 2016 Jun 14.
PubMed 27707525Surveillance report 2016 - Unstable angina and NSTEMI (2010) NICE guideline CG94 and Myocardial infarction with ST-segment elevation (2013) NICE guideline CG167 [Internet]. London: National Institute for Health and Care Excellence (UK); 2016 Sep 29. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK552026/
PubMed 31886964Klerdal K, Varenhorst C, James S, Alfredsson L, Blomberg H, Moradi T. Sex as a determinant of prehospital ECG in ST- and non-ST elevation myocardial infarction patients. Heart. 2014 Nov;100(22):1817-8. doi: 10.1136/heartjnl-2014-306412. Epub 2014 Jul 24. No abstract available.
PubMed 25060757Coventry LL, Finn J, Bremner AP. Sex differences in symptom presentation in acute myocardial infarction: a systematic review and meta-analysis. Heart Lung. 2011 Nov-Dec;40(6):477-91. doi: 10.1016/j.hrtlng.2011.05.001.
PubMed 22000678Cioffi J. A study of the use of past experiences in clinical decision making in emergency situations. Int J Nurs Stud. 2001 Oct;38(5):591-9. doi: 10.1016/s0020-7489(00)00096-1.
PubMed 11524105Croskerry P. Achieving quality in clinical decision making: cognitive strategies and detection of bias. Acad Emerg Med. 2002 Nov;9(11):1184-204. doi: 10.1111/j.1553-2712.2002.tb01574.x.
PubMed 12414468Hall KH. Reviewing intuitive decision-making and uncertainty: the implications for medical education. Med Educ. 2002 Mar;36(3):216-24. doi: 10.1046/j.1365-2923.2002.01140.x.
PubMed 11879511Tversky A, Kahneman D. Judgment under Uncertainty: Heuristics and Biases. Science. 1974 Sep 27;185(4157):1124-31. doi: 10.1126/science.185.4157.1124.
PubMed 17835457
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Impact of the Pre-hospital 12-lead Electrocardiogram in the Primary PCI Era: Mixed Methods Study (PHECG2)
- ClinicalTrials.gov ID
- NCT03699137
- Acronym / sponsor ID
- PHECG2 / ECCCR_PHECG2
- Conditions
- Acute Coronary Syndrome, STEMI, Non STEMI
- Keywords
- Acute coronary syndrome, Emergency Medical Services, Electrocardiogram, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420,048 participants (actual)
- Lead sponsor
- Kingston UniversityUniversity, hospital or other
- Collaborators
- Swansea University, University of Leeds, London Ambulance Service, West Midlands Ambulance Service NHS Foundation Trust, South West Ambulance Service NHS Foundation Trust
- Study start
- 6 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 9 Oct 2018 (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.
The Pre-Hospital 12-lead electrocardiogram (PHECG) is a simple test that helps ambulance clinicians assess patients with suspected acute coronary syndrome (heart attack), and provides clinical data to inform ongoing care. This project builds on previous work by this team, which found that one in three eligible patients did not receive a PHECG, but those that did had a lowered risk of short-term death. In this study the investigators will update that work, and explore reasons for variations in practice - highlighting opportunities to improve care and outcomes.
Using routinely collected data and qualitative methods, the investigators will research patient, practitioner and contextual factors contributing to the decision to administer a PHECG. The aim is also to develop an intervention to increase the proportion of eligible patients that receive a PHECG, and to produce a proposal for further funding to test this intervention in a subsequent randomised trial.
Detailed description
This mixed methods design study consists of four work packages:
WP1 - Population-based, linked cohort study using MINAP data from 2010-2016
This work package will entail analysis of data from around 420,000 pseudonymised patient records from the MINAP database, linking to the Office for National Statistics (ONS) in order to determine mortality/vital status. No patients will be contacted to obtain consent for inclusion of their records in the study as NICOR (custodian of MINAP data) hold section 251 exemption to hold and process patient data for clinical audit purposes without their explicit consent. The data will be released to the research team, using established processes, in pseudonymised format.
The study statisticians will analyse the data provided from MINAP to determine how many heart attack patients who came by ambulance survive to 30 days, estimate time to death, and will estimate from the data whether more people who had an ambulance ECG survive compared to those who did not have the test.
The aim of the study is also to determine from the data whether patients who have an ambulance ECG receive treatment in hospital faster than those who did not.
WP2 - Retrospective chart review of ambulance records
The study statisticians will generate from the larger sample discussed above, a smaller sample (approximately 1800 patients in total) specific to three National Health Service (NHS) ambulance services (Welsh, West Midlands and South West). The investigators will then work with those ambulance services to review the records held by the ambulance service, to see what other information over and above that is collected in the national MINAP audit (e.g. presenting symptoms, severity of any chest pain, public place or home, patient preferences including declining to have the test, ambulance clinician grade and gender). The investigators have worked with a 'task and finish group' of paramedics and cardiology experts to agree which data might be helpful and devised specific forms to collect these data. Data collection from ambulance records will be undertaken by NHS paramedics in the three ambulance services, seconded to work on this project. These paramedics will receive specific training in study procedures to ensure accuracy and data quality. Anonymised data collected by these 'research paramedics' will be sent to the research team by secure electronic database.
WP3 - Ambulance clinician self-report on PHECG recording
In this work package, clinical staff from the three participating ambulance Trusts (48 in total) will be invited to participate in focus group discussions led by an experienced researcher. A semi-structured topic guide (developed beforehand with the help and advice of a small group of paramedics and cardiac experts, and our knowledge of previous literature on paramedic decision making) will be used to explore the view of consenting ambulance clinicians about their perceptions of the role of the PHECG, their experiences of assessing patients with suspected heart attack, and factors which might influence the decision to record (or not) an ECG when assessing and treating a patient.
Focus group discussions will be audio-recorded and transcribed. A method called framework analysis will be used to analyse the transcribed records of the focus group discussions to see whether any particular themes arise, including consensus or disagreement of ambulance staff views on recording an ECG, and consider them against any differences in the characteristics of focus group participants (e.g. grade of clinician, employing ambulance service's local practice).
WP4 - Synthesis of the findings
The investigators will bring together ambulance staff, patient representatives, cardiac experts and researchers to consider the findings from the three work packages described above, with aim to synthesise the study findings and present evidence addressing the study research questions. This will be done with consideration of the investigators' work as forming the 'development phase' for the design of a complex intervention for further testing in a later study.
The project has been designed with input from patient and public representatives especially around the importance of the research question(s), potential impact of the findings for patients and the public. The study team includes three paramedics who have been instrumental in the design of the study as well as supporting documentation particularly for WP3.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases with confirmed ACS | – | Other: No interventionsCases with confirmed diagnosis of acute coronary syndrome in the MINAP database (national registry of ACS patients). No interventions apply to this group as this is an observational study. |
| EMS personnel | – | Other: No interventionsEmergency Medical Service (EMS) personnel will take part in the focus group. No intervention applies to this group in this qualitative component of the study. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two types of study populations: 1. - Patients with confirmed diagnosis of ACS in MINAP database as per inclusion and exclusion criteria 2. - Emergency Medical Service personnel who have been trained to perform 12 lead ECG.
Key inclusion criteria (8 listed)
- Patients > 18 years of age
- Patients with ACS
- Patients who have been brought to hospital by Emergency Medical Service (EMS)
- Patients included in the MINAP registry
- First episode of ACS
Key exclusion criteria (3 listed)
- patients < 18 years of age
- patients who self-presented at hospitals with suspected ACS
- patients who developed ACS whilst in hospital
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 interventionsNo interventions | Other | Cases with confirmed ACS, EMS personnel |
Primary outcome
WP1: 30-day mortality
Time frame: 30 days
Proportion of patients who die within 30 days of the date of their event
6 secondary outcomes
Time to death
Time frame: Up to one year
Hospital mortality
Time frame: Up to 90 days
One year mortality
Time frame: One year
Time under care of EMS
Time frame: Up to 3 hours
Use and type of reperfusion
Time frame: 24 hours
Time to treatment
Time frame: 24 hours
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 6 Apr 2020.
- Background: PubMed 26472852Welsford M, Nikolaou NI, Beygui F, Bossaert L, Ghaemmaghami C, Nonogi H, O'Connor RE, Pichel DR, Scott T, Walters DL, Woolfrey KG; Acute Coronary Syndrome Chapter Collaborators. Part 5: Acute Coronary Syndromes: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S146-76. doi: 10.1161/CIR.0000000000000274. No abstract available.
- Background: PubMed 26472997O'Connor RE, Al Ali AS, Brady WJ, Ghaemmaghami CA, Menon V, Welsford M, Shuster M. Part 9: Acute Coronary Syndromes: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S483-500. doi: 10.1161/CIR.0000000000000263. No abstract available.
- Background: PubMed 26477416Nikolaou NI, Arntz HR, Bellou A, Beygui F, Bossaert LL, Cariou A; Initial management of acute coronary syndromes section Collaborator. European Resuscitation Council Guidelines for Resuscitation 2015 Section 8. Initial management of acute coronary syndromes. Resuscitation. 2015 Oct;95:264-77. doi: 10.1016/j.resuscitation.2015.07.030. Epub 2015 Oct 15. No abstract available.
- Background: PubMed 21627394Tubaro M, Danchin N, Goldstein P, Filippatos G, Hasin Y, Heras M, Jansky P, Norekval TM, Swahn E, Thygesen K, Vrints C, Zahger D, Arntz HR, Bellou A, De La Coussaye JE, De Luca L, Huber K, Lambert Y, Lettino M, Lindahl B, McLean S, Nibbe L, Peacock WF, Price S, Quinn T, Spaulding C, Tatu-Chitoiu G, Van De Werf F. Pre-hospital treatment of STEMI patients. A scientific statement of the Working Group Acute Cardiac Care of the European Society of Cardiology. Acute Card Care. 2011 Jun;13(2):56-67. doi: 10.3109/17482941.2011.581292.
- Background: PubMed 24732676Quinn T, Johnsen S, Gale CP, Snooks H, McLean S, Woollard M, Weston C; Myocardial Ischaemia National Audit Project (MINAP) Steering Group. Effects of prehospital 12-lead ECG on processes of care and mortality in acute coronary syndrome: a linked cohort study from the Myocardial Ischaemia National Audit Project. Heart. 2014 Jun;100(12):944-50. doi: 10.1136/heartjnl-2013-304599. Epub 2014 Apr 14.
- Background: PubMed 16630989Curtis JP, Portnay EL, Wang Y, McNamara RL, Herrin J, Bradley EH, Magid DJ, Blaney ME, Canto JG, Krumholz HM; National Registry of Myocardial Infarction-4. The pre-hospital electrocardiogram and time to reperfusion in patients with acute myocardial infarction, 2000-2002: findings from the National Registry of Myocardial Infarction-4. J Am Coll Cardiol. 2006 Apr 18;47(8):1544-52. doi: 10.1016/j.jacc.2005.10.077. Epub 2006 Mar 29.
- Background: PubMed 19130984Diercks DB, Kontos MC, Chen AY, Pollack CV Jr, Wiviott SD, Rumsfeld JS, Magid DJ, Gibler WB, Cannon CP, Peterson ED, Roe MT. Utilization and impact of pre-hospital electrocardiograms for patients with acute ST-segment elevation myocardial infarction: data from the NCDR (National Cardiovascular Data Registry) ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry. J Am Coll Cardiol. 2009 Jan 13;53(2):161-6. doi: 10.1016/j.jacc.2008.09.030.
- Background: PubMed 27707525Ducas RA, Labos C, Allen D, Golian M, Jeyaraman M, Lys J, Mann A, Copstein L, Vokey S, Rabbani R, Zarychanski R, Abou-Setta AM, Menkis AH. Association of Pre-hospital ECG Administration With Clinical Outcomes in ST-Segment Myocardial Infarction: A Systematic Review and Meta-analysis. Can J Cardiol. 2016 Dec;32(12):1531-1541. doi: 10.1016/j.cjca.2016.06.004. Epub 2016 Jun 14.
- Background: PubMed 31886964Surveillance report 2016 - Unstable angina and NSTEMI (2010) NICE guideline CG94 and Myocardial infarction with ST-segment elevation (2013) NICE guideline CG167 [Internet]. London: National Institute for Health and Care Excellence (UK); 2016 Sep 29. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK552026/
- Background: PubMed 25060757Klerdal K, Varenhorst C, James S, Alfredsson L, Blomberg H, Moradi T. Sex as a determinant of prehospital ECG in ST- and non-ST elevation myocardial infarction patients. Heart. 2014 Nov;100(22):1817-8. doi: 10.1136/heartjnl-2014-306412. Epub 2014 Jul 24. No abstract available.
- Background: PubMed 22000678Coventry LL, Finn J, Bremner AP. Sex differences in symptom presentation in acute myocardial infarction: a systematic review and meta-analysis. Heart Lung. 2011 Nov-Dec;40(6):477-91. doi: 10.1016/j.hrtlng.2011.05.001.
- Background: PubMed 11524105Cioffi J. A study of the use of past experiences in clinical decision making in emergency situations. Int J Nurs Stud. 2001 Oct;38(5):591-9. doi: 10.1016/s0020-7489(00)00096-1.
- What is NVivoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tom Quinn, FESC FAHA FACC principal investigator
Kingston University & St George's, University of London
3 sites 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 STEMI, run by Kingston University at 3 sites in United Kingdom.
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 3 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 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
WP1: 30-day mortality (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 NCT03699137, which also lists 31 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 6 Apr 2020.