Improving the Accuracy of Referrals of Patients With Chest Pain
NCT ID: NCT04904107
Last Updated: 2022-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
852 participants
INTERVENTIONAL
2021-07-04
2024-06-01
Brief Summary
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Detailed Description
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Bedside point-of-care (POC) high sensitive troponin testing (in fingerprick blood/capillary blood) and the modified HEART score have become available and might play a substantial role in the triage and diagnosis of chest pain patients in a pre-hospital setting by general practitioners (GPs) and EMT personnel in the future. We hypothesize that patients with chest pain can be referred more accurately by using the modified HEART score.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Intervention group
Chest pain patients in the intervention group will be assessed by EMT personnel by performing the modified HEART score (including POC high sensitive troponin-I measurement (POC HS cTnI)) and the referral policy depends on the result.
* In case of a low modified HEART score (modified HEART 0-3) patients will not be referred to the cardiac ED.
* Patients with a modified HEART score \>3 are directly referred to the cardiac ED after evaluation. These patients will receive standard care.
modified HEART score (including POC hs cTnI analysis)
The modified HEART score was developed in 2007 and has been validated to stratify the risk of short-term adverse cardiac events in patients with chest pain at the ED. Negative predictive value (NPV) of the modified HEART score for ACS as well as positive predictive value (PPV) for major adverse cardiac events (MACE) within 6 weeks after presentation is high.
The modified HEART score is an acronym for history, ECG, age, risk factors and troponin at arrival.The components can be rated 0,1 or 2 points each and result in a total score between 0 and 10.
Control group
Chest pain patients in the control group will receive standard triage and standard care according to the local (EMT) protocol.
Standard care and triage according to the local (EMT)protocol.
Standard care and triage of chest pain patients according to the local (EMT)protocol.
Interventions
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modified HEART score (including POC hs cTnI analysis)
The modified HEART score was developed in 2007 and has been validated to stratify the risk of short-term adverse cardiac events in patients with chest pain at the ED. Negative predictive value (NPV) of the modified HEART score for ACS as well as positive predictive value (PPV) for major adverse cardiac events (MACE) within 6 weeks after presentation is high.
The modified HEART score is an acronym for history, ECG, age, risk factors and troponin at arrival.The components can be rated 0,1 or 2 points each and result in a total score between 0 and 10.
Standard care and triage according to the local (EMT)protocol.
Standard care and triage of chest pain patients according to the local (EMT)protocol.
Eligibility Criteria
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Inclusion Criteria
* Chest pain or other complaints suspect of ACS for at least 2 hours where the GP or emergency medical personnel are in need of further diagnostics or risk stratification to come to a decision of referral.
* Patients, who have been informed of the nature of the study, agree to its provisions and have provided written informed consent.
Exclusion Criteria
* Suspicion of an acute non-coronary diagnosis e.g. pulmonary embolism, thoracic aortic dissection or other life-threatening disease.
* Patients presenting cardiogenic shock, defined as: systolic blood pressure \<90mmHg and heart rate \>100 and peripheral oxygen saturation \<90% (without oxygen administration)
* Patients presenting with sudden onset heart rhythm disorders and second or third degree atrioventricular block.
* Patients with confirmed ACS, PCI or CABG \<30 days prior to inclusion.
* Impaired consciousness defined as an EMV \<8.
* Severe shortness of breath.
* Patients with known end-stage renal disease (dialysis and/or MDRD \< 30 ml/min).
* Patients with known cognitive impairment.
* Communication issues with patient/language barrier.
* Patients already participating in an interventional cardiology or cardiovascular trial.
18 Years
ALL
No
Sponsors
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Siemens Healthineers Nederland B.V.
UNKNOWN
VieCuri Medical Centre
OTHER
Responsible Party
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Braim Rahel
Principal investigator
Principal Investigators
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Braim Rahel, Dr.
Role: PRINCIPAL_INVESTIGATOR
Viecuri Medical Centre Northern Limburg
Joan Meeder, Dr.
Role: PRINCIPAL_INVESTIGATOR
Viecuri Medical Centre Northern Limburg
Cees de Vos, Dr.
Role: PRINCIPAL_INVESTIGATOR
Laurentius Hospital Roermond
Arnoud van 't Hof, Prof. dr.
Role: STUDY_DIRECTOR
Zuyderland MC
Robert Willemsen, Dr.
Role: STUDY_DIRECTOR
General practitioner office Nazareth Maastricht
Locations
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Laurentius Hospital Roermond
Roermond, Limburg, Netherlands
Viecuri Medical Centre Northern Limburg
Venlo, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Cees de Vos, Dr.
Role: primary
Braim Rahel, Dr.
Role: primary
Joan Meeder, Dr.
Role: backup
References
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Frenk LDS, Rahel BM, de Vos CB, van Osch FHM, Prestigiacomo FG, Janssen MJW, Willemsen RTA, van 't Hof AW, Meeder JG. Improving the accUracy of Referrals to the emerGency departmEnt of patieNts with chesT pain using the modified HEART score in Emergency Medical Transport (URGENT 2.0): protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Dec 20;14(12):e084139. doi: 10.1136/bmjopen-2024-084139.
Other Identifiers
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NL71820.096.19
Identifier Type: OTHER
Identifier Source: secondary_id
Study number 2021_002
Identifier Type: -
Identifier Source: org_study_id
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