Acute Coronary SyndromeUrgentNCT03115190
Improving the Referral of Patients With Chest Pain
A study testing General Practitioner diagnosis with Heart score in people with Acute Coronary Syndrome and Myocardial Infarction, run by VieCuri Medical Centre at 1 site in Netherlands.
Trial summary
Rationale: This study aims to aid the general practitioner (GP) in the diagnostic dilemma of chest pain patients. Patients with acute coronary syndrome (ACS) should be referred to the hospital promptly, though referring all patients with chest pain is not feasible, as up to 80% of the patients with chest pain in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, Chest Pain
- What is being tested?
- General Practitioner diagnosis with Heart score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Apr 2017to 1 Nov 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with chest pain or other complaints suspect of acute coronary syndrome (ACS) can be included in which the general practitioner is in need of further diagnostics to come to a decision of referral.
- All patients referred to the emergency department (ED) with suspected ACS will be included to evaluate the appropriateness of referral.
Who cannot join
- Patients younger than 18 years
- Patients in which a typical history and/or physical examination requires immediate referral; high suspicion of ACS
- Patients in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.
- The baseline of patients seen at the ED will not exclude any patients referred with suspected ACS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study to Improve the Accuracy of Referrals of Patients With Chest Pain to the Emergency Department: to Decrease the Delay in Acute Coronary Syndrome Patients and Rule Out Non-cardiac Chest Pain Patients (URGENT)
Rationale: This study aims to aid the general practitioner (GP) in the diagnostic dilemma of chest pain patients. Patients with acute coronary syndrome (ACS) should be referred to the hospital promptly, though referring all patients with chest pain is not feasible, as up to 80% of the patients with chest pain in the primary care do not have ACS.
Objective: The primary objective is to refer patients who contact the out-of-hours GP cooperation (GPC) with suspicion of ACS more accurately with a hypothesized reduction of 10% in unnecessary referrals.
Read more
Study design: This study is a prospective, observational, prevalence-based cohort study within the standard care of ACS patients.
Study population: All patients with chest pain, or other complaints suspect of ACS, will be included in which the GP at the GPC is in need of further diagnostics to come to a decision of referral. The follow-up will be a registry of all patients with suspected ACS referred to the emergency department (ED). Patients with typical complaints of ACS, and thus a high suspicion, will be excluded and referred promptly.
Intervention: Triage nurses working at the GPC will receive specific ACS training. Patients who arrive at the GPC with non-typical chest pain, will be screened for enrolment within the study. The GP evaluates patients using the Heart score, this includes electrocardiogram recording and point of care (POC) troponin testing. With the Heart score the GP can make an informed decision to refer the patient to the ED.
To evaluate the intervention a registry of all patients referred to the ED with suspected ACS will be compared to a baseline registry performed from the 1st of September 2015 until the 1st of March 2016. Patients not referred to the ED, will have a (standard) high-sensitivity troponin and a POC troponin as follow-up at least four hours (up to 24 hours) after first measurement.
The burden and risks associated with participation, benefit and group relatedness: Patients enrolled within this study will receive a finger stick blood test and electrocardiogram recording at the GPC and a finger stick blood test and a venous blood test at least four hours after first troponin measurement. We may follow-up by telephone if we can not obtain the required information from medical records. We expect no adverse events and there are no expected risks associated with this protocol. We expect patients with ACS to be referred more accurately and more promptly to the ED and thus lowering risks.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction, Chest Pain
- Being tested
- General Practitioner diagnosis with Heart score
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Practitioner diagnosis with Heart scoreDiagnostic test
All patients seen by the general practitioner (GP) at the GP cooperation and agreeing to participation will be evaluated with the Heart score. This is a score including history, electrocardiogram, age, risk factors and troponin to assess whether a patient is at high risk for acute coronary syndrome. The troponins asked for in the Heart score are at arrival of the patient, not regarding the time of onset of chest pain. We shall use point of care (POC) troponin, thereby modifying the Heart score. The GP must realize that the POC troponin is not reliable on its own with one test. If the Heart score is low, it is acceptable and safe to not refer the patient, it is however not safe to refer the patient solely on negative troponin result.
| Study group | Role | What they receive |
|---|---|---|
| General practitioner diagnosis with Heart score | Other | Patients with chest pain who are reviewed by the general practitioner (GP) at the GP cooperation will be evaluated with the Heart score to support the GP with the diagnosis. Receives: Diagnostic Test: General Practitioner diagnosis with Heart score |
| Triage Nurse education | No intervention | The general practitioner cooperation employs nurses for (telephone) triage. They are aided by a computer based triage system, the Netherlands triage system (NTS), a 6-level urgency triage system. With this study we aim to educate the nurses in the signs and symptoms of chest pain patients. The training program will aim to educate the triage nurses in acute coronary syndrome, including pathophysiology, symptoms and risk factors. The NTS will be incorporated within the training. The triage nurses will receive a training session by Cardiologists with information about acute coronary syndrome, the symptoms and the risks. |
| Baseline registry as comparison | No intervention | All patients referred to the emergency department (ED) with suspected acute coronary syndrome (ACS) will be evaluated. They will receive a questionnaire to evaluate the accuracy of referral and the delays of ACS patients. This will be compared to the registry at baseline. Some patients will either have not contacted the general practitioner cooperation (GPC) at all, or will have been referred to the ED directly through the GPC nurse triage. The 30 day, 6 months and one year follow-up of all patients will be via medical records, or in case of no or not enough information, by telephone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suspected diagnosis
The primary outcome measure is a more accurate referral of patients with suspected acute coronary syndrome (ACS) to the cardiac emergency department and thus the concordance of suspected ACS and the actual diagnosis. The endpoint will be compared to the baseline registry that has been executed from 1st of September 2015 until 1st of March 2016.
Measured: 30 days
Secondary outcomes (1)
Major adverse cardiovascular events
Combination endpoint of: mortality and any ischemic event (ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, (Unstable)Angina Pectoris, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Resuscitation)
Measured: 30 days, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start18 Apr 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 2018
Why it stopped: The Philips Minicare has been taken off the market due to financial company issues that have nothing to do with the safety of the Minicare or the URGENT trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- VieCuri Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115190
- Sponsor's protocol ID
- Rahel2017Urgent
- Acronym
- Urgent
- Status last verified
- Jan 2021
- First submitted
- 11 Apr 2017
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available to other researchers to secure privacy in study patients.
Publications
Verdon F, Herzig L, Burnand B, Bischoff T, Pecoud A, Junod M, Muhlemann N, Favrat B; GMIRG. Chest pain in daily practice: occurrence, causes and management. Swiss Med Wkly. 2008 Jun 14;138(23-24):340-7. doi: 10.4414/smw.2008.12123.
PubMed 18561039Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.
PubMed 22922416Bosner S, Becker A, Haasenritter J, Abu Hani M, Keller H, Sonnichsen AC, Karatolios K, Schaefer JR, Seitz G, Baum E, Donner-Banzhoff N. Chest pain in primary care: epidemiology and pre-work-up probabilities. Eur J Gen Pract. 2009;15(3):141-6. doi: 10.3109/13814780903329528.
PubMed 19883149Ruddox V, Mathisen M, Otterstad JE. Prevalence and prognosis of non-specific chest pain among patients hospitalized for suspected acute coronary syndrome - a systematic literature search. BMC Med. 2012 Jun 12;10:58. doi: 10.1186/1741-7015-10-58.
PubMed 22691301Webster R, Norman P, Goodacre S, Thompson A. The prevalence and correlates of psychological outcomes in patients with acute non-cardiac chest pain: a systematic review. Emerg Med J. 2012 Apr;29(4):267-73. doi: 10.1136/emermed-2011-200526. Epub 2011 Oct 27.
PubMed 22034535Weinstock MB, Weingart S, Orth F, VanFossen D, Kaide C, Anderson J, Newman DH. Risk for Clinically Relevant Adverse Cardiac Events in Patients With Chest Pain at Hospital Admission. JAMA Intern Med. 2015 Jul;175(7):1207-12. doi: 10.1001/jamainternmed.2015.1674.
PubMed 25985100Knockaert DC, Buntinx F, Stoens N, Bruyninckx R, Delooz H. Chest pain in the emergency department: the broad spectrum of causes. Eur J Emerg Med. 2002 Mar;9(1):25-30. doi: 10.1097/00063110-200203000-00007.
PubMed 11989492Huibers L, Giesen P, Smits M, Mokkink H, Grol R, Wensing M. Nurse telephone triage in Dutch out-of-hours primary care: the relation between history taking and urgency estimation. Eur J Emerg Med. 2012 Oct;19(5):309-15. doi: 10.1097/MEJ.0b013e32834d3e67.
PubMed 22008589Nilsson S, Ortoft K, Molstad S. The accuracy of general practitioners' clinical assessment of chest pain patients. Eur J Gen Pract. 2008;14(2):50-5. doi: 10.1080/13814780802342622.
PubMed 18720273Wilcox HM, Vickery AW, Emery JD. Cardiac troponin testing for diagnosis of acute coronary syndromes in primary care. Med J Aust. 2015 Oct 19;203(8):336. doi: 10.5694/mja14.01154.
PubMed 26465699Backus 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 20802272Leite L, Baptista R, Leitao J, Cochicho J, Breda F, Elvas L, Fonseca I, Carvalho A, Costa JN. Chest pain in the emergency department: risk stratification with Manchester triage system and HEART score. BMC Cardiovasc Disord. 2015 Jun 11;15:48. doi: 10.1186/s12872-015-0049-6.
PubMed 26062607Ishak M, Ali D, Fokkert MJ, Slingerland RJ, Tolsma RT, Badings E, van der Sluis A, van Eenennaam F, Mosterd A, Ten Berg JM, van 't Hof AW. Fast assessment and management of chest pain patients without ST-elevation in the pre-hospital gateway (FamouS Triage): ruling out a myocardial infarction at home with the modified HEART score. Eur Heart J Acute Cardiovasc Care. 2018 Mar;7(2):102-110. doi: 10.1177/2048872616687116. Epub 2017 Jan 13.
PubMed 28084079
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Improve the Accuracy of Referrals of Patients With Chest Pain to the Emergency Department: to Decrease the Delay in Acute Coronary Syndrome Patients and Rule Out Non-cardiac Chest Pain Patients (URGENT)
- ClinicalTrials.gov ID
- NCT03115190
- Acronym / sponsor ID
- Urgent / Rahel2017Urgent
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction, Chest Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Philips Minicare has been taken off the market due to financial company issues that have nothing to do with the safety of the Minicare or the URGENT trial.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- VieCuri Medical CentreUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 14 Apr 2017 (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.
Rationale: This study aims to aid the general practitioner (GP) in the diagnostic dilemma of chest pain patients. Patients with acute coronary syndrome (ACS) should be referred to the hospital promptly, though referring all patients with chest pain is not feasible, as up to 80% of the patients with chest pain in the primary care do not have ACS.
Objective: The primary objective is to refer patients who contact the out-of-hours GP cooperation (GPC) with suspicion of ACS more accurately with a hypothesized reduction of 10% in unnecessary referrals.
Study design: This study is a prospective, observational, prevalence-based cohort study within the standard care of ACS patients.
Study population: All patients with chest pain, or other complaints suspect of ACS, will be included in which the GP at the GPC is in need of further diagnostics to come to a decision of referral. The follow-up will be a registry of all patients with suspected ACS referred to the emergency department (ED). Patients with typical complaints of ACS, and thus a high suspicion, will be excluded and referred promptly.
Intervention: Triage nurses working at the GPC will receive specific ACS training. Patients who arrive at the GPC with non-typical chest pain, will be screened for enrolment within the study. The GP evaluates patients using the Heart score, this includes electrocardiogram recording and point of care (POC) troponin testing. With the Heart score the GP can make an informed decision to refer the patient to the ED.
To evaluate the intervention a registry of all patients referred to the ED with suspected ACS will be compared to a baseline registry performed from the 1st of September 2015 until the 1st of March 2016. Patients not referred to the ED, will have a (standard) high-sensitivity troponin and a POC troponin as follow-up at least four hours (up to 24 hours) after first measurement.
The burden and risks associated with participation, benefit and group relatedness: Patients enrolled within this study will receive a finger stick blood test and electrocardiogram recording at the GPC and a finger stick blood test and a venous blood test at least four hours after first troponin measurement. We may follow-up by telephone if we can not obtain the required information from medical records. We expect no adverse events and there are no expected risks associated with this protocol. We expect patients with ACS to be referred more accurately and more promptly to the ED and thus lowering risks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General practitioner diagnosis with Heart score | Other | Diagnostic Test: General Practitioner diagnosis with Heart scorePatients with chest pain who are reviewed by the general practitioner (GP) at the GP cooperation will be evaluated with the Heart score to support the GP with the diagnosis. |
| Triage Nurse education | No intervention | –The general practitioner cooperation employs nurses for (telephone) triage. They are aided by a computer based triage system, the Netherlands triage system (NTS), a 6-level urgency triage system. With this study we aim to educate the nurses in the signs and symptoms of chest pain patients. The training program will aim to educate the triage nurses in acute coronary syndrome, including pathophysiology, symptoms and risk factors. The NTS will be incorporated within the training. The triage nurses will receive a training session by Cardiologists with information about acute coronary syndrome, the symptoms and the risks. |
| Baseline registry as comparison | No intervention | –All patients referred to the emergency department (ED) with suspected acute coronary syndrome (ACS) will be evaluated. They will receive a questionnaire to evaluate the accuracy of referral and the delays of ACS patients. This will be compared to the registry at baseline. Some patients will either have not contacted the general practitioner cooperation (GPC) at all, or will have been referred to the ED directly through the GPC nurse triage. The 30 day, 6 months and one year follow-up of all patients will be via medical records, or in case of no or not enough information, by telephone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with chest pain or other complaints suspect of acute coronary syndrome (ACS) can be included in which the general practitioner is in need of further diagnostics to come to a decision of referral.
- All patients referred to the emergency department (ED) with suspected ACS will be included to evaluate the appropriateness of referral.
Key exclusion criteria (4 listed)
- Patients younger than 18 years
- Patients in which a typical history and/or physical examination requires immediate referral; high suspicion of ACS
- Patients in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.
- The baseline of patients seen at the ED will not exclude any patients referred with suspected ACS.
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 |
|---|---|---|
| General Practitioner diagnosis with Heart scoreAll patients seen by the general practitioner (GP) at the GP cooperation and agreeing to participation will be evaluated with the Heart score. This is a score including history, electrocardiogram, age, risk factors and troponin to assess whether a patient is at high risk for acute coronary syndrome. The troponins asked for in the Heart score are at arrival of the patient, not regarding the time of onset of chest pain. We shall use point of care (POC) troponin, thereby modifying the Heart score. The GP must realize that the POC troponin is not reliable on its own with one test. If the Heart score is low, it is acceptable and safe to not refer the patient, it is however not safe to refer the patient solely on negative troponin result. | Diagnostic test | General practitioner diagnosis with Heart score |
Primary outcome
Suspected diagnosis
Time frame: 30 days
The primary outcome measure is a more accurate referral of patients with suspected acute coronary syndrome (ACS) to the cardiac emergency department and thus the concordance of suspected ACS and the actual diagnosis. The endpoint will be compared to the baseline registry that has been executed from 1st of September 2015 until 1st of March 2016.
1 secondary outcome
Major adverse cardiovascular events
Time frame: 30 days, 6 months and 1 year
Results and safety
The study was stopped early (reason given: The Philips Minicare has been taken off the market due to financial company issues that have nothing to do with the safety of the Minicare or the URGENT trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Background: PubMed 18561039Verdon F, Herzig L, Burnand B, Bischoff T, Pecoud A, Junod M, Muhlemann N, Favrat B; GMIRG. Chest pain in daily practice: occurrence, causes and management. Swiss Med Wkly. 2008 Jun 14;138(23-24):340-7. doi: 10.4414/smw.2008.12123.
- Background: PubMed 22922416Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.
- Background: PubMed 19883149Bosner S, Becker A, Haasenritter J, Abu Hani M, Keller H, Sonnichsen AC, Karatolios K, Schaefer JR, Seitz G, Baum E, Donner-Banzhoff N. Chest pain in primary care: epidemiology and pre-work-up probabilities. Eur J Gen Pract. 2009;15(3):141-6. doi: 10.3109/13814780903329528.
- Background: PubMed 22691301Ruddox V, Mathisen M, Otterstad JE. Prevalence and prognosis of non-specific chest pain among patients hospitalized for suspected acute coronary syndrome - a systematic literature search. BMC Med. 2012 Jun 12;10:58. doi: 10.1186/1741-7015-10-58.
- Background: PubMed 22034535Webster R, Norman P, Goodacre S, Thompson A. The prevalence and correlates of psychological outcomes in patients with acute non-cardiac chest pain: a systematic review. Emerg Med J. 2012 Apr;29(4):267-73. doi: 10.1136/emermed-2011-200526. Epub 2011 Oct 27.
- Background: PubMed 25985100Weinstock MB, Weingart S, Orth F, VanFossen D, Kaide C, Anderson J, Newman DH. Risk for Clinically Relevant Adverse Cardiac Events in Patients With Chest Pain at Hospital Admission. JAMA Intern Med. 2015 Jul;175(7):1207-12. doi: 10.1001/jamainternmed.2015.1674.
- Background: PubMed 11989492Knockaert DC, Buntinx F, Stoens N, Bruyninckx R, Delooz H. Chest pain in the emergency department: the broad spectrum of causes. Eur J Emerg Med. 2002 Mar;9(1):25-30. doi: 10.1097/00063110-200203000-00007.
- Background: PubMed 22008589Huibers L, Giesen P, Smits M, Mokkink H, Grol R, Wensing M. Nurse telephone triage in Dutch out-of-hours primary care: the relation between history taking and urgency estimation. Eur J Emerg Med. 2012 Oct;19(5):309-15. doi: 10.1097/MEJ.0b013e32834d3e67.
- Background: PubMed 18720273Nilsson S, Ortoft K, Molstad S. The accuracy of general practitioners' clinical assessment of chest pain patients. Eur J Gen Pract. 2008;14(2):50-5. doi: 10.1080/13814780802342622.
- Background: PubMed 26465699Wilcox HM, Vickery AW, Emery JD. Cardiac troponin testing for diagnosis of acute coronary syndromes in primary care. Med J Aust. 2015 Oct 19;203(8):336. doi: 10.5694/mja14.01154.
- Background: PubMed 20802272Backus 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.
- Background: PubMed 26062607Leite L, Baptista R, Leitao J, Cochicho J, Breda F, Elvas L, Fonseca I, Carvalho A, Costa JN. Chest pain in the emergency department: risk stratification with Manchester triage system and HEART score. BMC Cardiovasc Disord. 2015 Jun 11;15:48. doi: 10.1186/s12872-015-0049-6.
- Individual participant dataSharing planned: No. IPD will not be made available to other researchers to secure privacy in study patients.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Practitioner diagnosis with Heart score in people with Acute Coronary Syndrome and Myocardial Infarction, run by VieCuri Medical Centre at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 Jan 2021. 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 Netherlands. 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 was stopped early (reason given: The Philips Minicare has been taken off the market due to financial company issues that have nothing to do with the safety of the Minicare or the URGENT trial.). Results are not available in the source record.
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?
Suspected diagnosis (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 NCT03115190, which also lists 13 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 7 Jan 2021.