Back to resultsImproving the Accuracy of Referrals of Patients With Chest Pain (URGENT2)
Primary Purpose
Chest Pain, Acute Coronary Syndrome, Myocardial Infarction
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
modified HEART score (including POC hs cTnI analysis)
Standard care and triage according to the local (EMT)protocol.
Sponsored by
About this trial
This is an interventional diagnostic trial for Chest Pain focused on measuring Modified HEART score, Point-of-care testing, Troponin, Siemens Healthineers
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years.
- 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:
- Electrocardiographic ST-segment elevation/High suspicion of STE-ACS.
- 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.
Sites / Locations
- Laurentius Hospital RoermondRecruiting
- Viecuri Medical Centre Northern LimburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
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.
Chest pain patients in the control group will receive standard triage and standard care according to the local (EMT) protocol.
Outcomes
Primary Outcome Measures
The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED (percentage, %)
Evaluation of the percentage of NCCP patients admitted to the cardiac ED by performing the modified HEART score in comparison to our control group (regular triage and care). We aim to detect a reduction of minimal 10% in unnecessarily referred chest pain patients (NCCP patients) but expect an even higher percentage. A lower percentage of NCCP patients indicates improval of the triage of chest pain patients.
The incidence of MACE (percentage, %)
The mortality and major adverse cardiovascular events (MACE) i.e. acute myocardial infarction, non-elective percutaneous coronary intervention, coronary artery bypass grafting or all cause death within 30 days, 6 months and 1 year after initial presentation in the intervention group versus control group.
We aim that the proportion of MACE in the intervention group (modified HEART score) is non-inferior to the control group (regular care and triage). Preliminary results of the second phase of FAMOUS Triage trial showed 15.7% (13.1-18.6) MACE rate.We used the expected incidence of 15.7% as the point estimate (meaning no difference between control and intervention). A higher MACE rate (%) in the intervention group suggests a worst outcome.
Secondary Outcome Measures
The incidence of MACE in subgroups (percentage, %)
Prespecified subgroup analyses of primary outcomes will be performed for:
Diabetic patients versus non-diabetic patients.
Male versus female patients
Patients referred by GP versus patient referred by triage nurse at GP cooperatives (GPC) versus self referrals.
The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED in subgroups (percentage, %)
Prespecified subgroup analyses of primary outcomes will be performed for:
Diabetic patients versus non-diabetic patients.
Male versus female patients
Patients referred by GP versus patient referred by triage nurse at GP cooperatives (GPC) versus self referrals.
Cost-effectiveness analysis
This economic evaluation investigates the health care costs of full implementation of a prehospital rule- out strategy with the modified HEART score (intervention group) compared with regular care and standard transfer to the hospital to rule out ACS (control group). Health-care costs will be prospectively recorded at baseline and at 30 days follow-up, 6 months and 1 year. This includes health care costs due to readmission, diagnostic testing, revascularization etc. The cost of hospital treatment is determined by the Dutch Diagnose Behandel Combinatie (DBC) hospital reimbursement system and the DBC information system, similar to the international diagnosis related group system.
Assessment of the diagnostic value of the modified HEART score.
Positive Predictive Value (PPV), sensitivity, specificity and Negative Predictive Value (NPV) of the modified HEART score for ACS will be calculated.
Overview of the actual diagnosis of patients with a low modified HEART score (0-3).
To evaluate the percentage of patients in this specific group with ACS versus no-ACS.
Overview of the actual diagnosis of patients with moderate-high modified HEART score (>3).
To evaluate the percentage of patients in this specific group with ACS versus no-ACS.
Clinical accuracy POC hs cTnI.
Clinical accuracy (Positive Predictive value) of POC hs cTnI assessment versus hs cTnT at the cardiac ED.
Time analysis.
Time elapsed from arrival EMT at patient's home to arrival at ED in intervention group versus control group.
Full Information
NCT ID
NCT04904107
First Posted
May 11, 2021
Last Updated
June 9, 2022
Sponsor
VieCuri Medical Centre
Collaborators
Siemens Healthineers Nederland B.V.
1. Study Identification
Unique Protocol Identification Number
NCT04904107
Brief Title
Improving the Accuracy of Referrals of Patients With Chest Pain
Acronym
URGENT2
Official Title
A Multicentre Randomized Controlled Trial to Improve the accUracy of Referrals to the emerGency departmEnt of patieNts With chesT Pain by Using the Modified HEART Score in Emergency Medical Transport (URGENT 2.0)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VieCuri Medical Centre
Collaborators
Siemens Healthineers Nederland B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multicenter, prospective, investigator-initiated, randomized controlled trial aiming to reduce the percentage of non-cardiac chest pain (NCCP) patients admitted to the cardiac emergency department (ED) by performing the modified HEART score by emergency medical transport (EMT) personnel.
Detailed Description
Patients with acute coronary syndrome (ACS) should be referred to the hospital promptly. However, referring all patients with chest pain is not feasible, as recent studies showed that up to 80% of the patients with acute chest pain do not have ACS.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia, Heart Attack
Keywords
Modified HEART score, Point-of-care testing, Troponin, Siemens Healthineers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It concerns an investigator initiated prospective 1:1 randomised clinical trial in chest pain patients in a pre-hospital setting. Patients will be randomised to (A, intervention group) a direct assessment of the modified HEART score (including POC high sensitive troponin measurement) by EMT personnel and refrainment of transport to the cardiac emergency department (ED) in cases of a low score or (B, control group) regular triage and hospital evaluation, taking place at the cardiac ED in the majority of cases.
Masking
Care ProviderInvestigator
Masking Description
EMT personnel will be blinded for the randomisation sequence.
Allocation
Randomized
Enrollment
852 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Chest pain patients in the control group will receive standard triage and standard care according to the local (EMT) protocol.
Intervention Type
Diagnostic Test
Intervention Name(s)
modified HEART score (including POC hs cTnI analysis)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care and triage according to the local (EMT)protocol.
Intervention Description
Standard care and triage of chest pain patients according to the local (EMT)protocol.
Primary Outcome Measure Information:
Title
The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED (percentage, %)
Description
Evaluation of the percentage of NCCP patients admitted to the cardiac ED by performing the modified HEART score in comparison to our control group (regular triage and care). We aim to detect a reduction of minimal 10% in unnecessarily referred chest pain patients (NCCP patients) but expect an even higher percentage. A lower percentage of NCCP patients indicates improval of the triage of chest pain patients.
Time Frame
30 days
Title
The incidence of MACE (percentage, %)
Description
The mortality and major adverse cardiovascular events (MACE) i.e. acute myocardial infarction, non-elective percutaneous coronary intervention, coronary artery bypass grafting or all cause death within 30 days, 6 months and 1 year after initial presentation in the intervention group versus control group.
We aim that the proportion of MACE in the intervention group (modified HEART score) is non-inferior to the control group (regular care and triage). Preliminary results of the second phase of FAMOUS Triage trial showed 15.7% (13.1-18.6) MACE rate.We used the expected incidence of 15.7% as the point estimate (meaning no difference between control and intervention). A higher MACE rate (%) in the intervention group suggests a worst outcome.
Time Frame
30 days, 6 months and 1 year
Secondary Outcome Measure Information:
Title
The incidence of MACE in subgroups (percentage, %)
Description
Prespecified subgroup analyses of primary outcomes will be performed for:
Diabetic patients versus non-diabetic patients.
Male versus female patients
Patients referred by GP versus patient referred by triage nurse at GP cooperatives (GPC) versus self referrals.
Time Frame
30 days, 6 months and 1 year
Title
The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED in subgroups (percentage, %)
Description
Prespecified subgroup analyses of primary outcomes will be performed for:
Diabetic patients versus non-diabetic patients.
Male versus female patients
Patients referred by GP versus patient referred by triage nurse at GP cooperatives (GPC) versus self referrals.
Time Frame
30 days, 6 months and 1 year
Title
Cost-effectiveness analysis
Description
This economic evaluation investigates the health care costs of full implementation of a prehospital rule- out strategy with the modified HEART score (intervention group) compared with regular care and standard transfer to the hospital to rule out ACS (control group). Health-care costs will be prospectively recorded at baseline and at 30 days follow-up, 6 months and 1 year. This includes health care costs due to readmission, diagnostic testing, revascularization etc. The cost of hospital treatment is determined by the Dutch Diagnose Behandel Combinatie (DBC) hospital reimbursement system and the DBC information system, similar to the international diagnosis related group system.
Time Frame
30 days, 6 months and 1 year
Title
Assessment of the diagnostic value of the modified HEART score.
Description
Positive Predictive Value (PPV), sensitivity, specificity and Negative Predictive Value (NPV) of the modified HEART score for ACS will be calculated.
Time Frame
30 days, 6 months and 1 year
Title
Overview of the actual diagnosis of patients with a low modified HEART score (0-3).
Description
To evaluate the percentage of patients in this specific group with ACS versus no-ACS.
Time Frame
30 days
Title
Overview of the actual diagnosis of patients with moderate-high modified HEART score (>3).
Description
To evaluate the percentage of patients in this specific group with ACS versus no-ACS.
Time Frame
30 days
Title
Clinical accuracy POC hs cTnI.
Description
Clinical accuracy (Positive Predictive value) of POC hs cTnI assessment versus hs cTnT at the cardiac ED.
Time Frame
30 days
Title
Time analysis.
Description
Time elapsed from arrival EMT at patient's home to arrival at ED in intervention group versus control group.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years.
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:
Electrocardiographic ST-segment elevation/High suspicion of STE-ACS.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Frenk, Drs.
Phone
0031773205555
Email
lfrenk@viecuri.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Braim Rahel, Dr.
Organizational Affiliation
Viecuri Medical Centre Northern Limburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joan Meeder, Dr.
Organizational Affiliation
Viecuri Medical Centre Northern Limburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cees de Vos, Dr.
Organizational Affiliation
Laurentius Hospital Roermond
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnoud van 't Hof, Prof. dr.
Organizational Affiliation
Zuyderland MC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Willemsen, Dr.
Organizational Affiliation
General practitioner office Nazareth Maastricht
Official's Role
Study Director
Facility Information:
Facility Name
Laurentius Hospital Roermond
City
Roermond
State/Province
Limburg
ZIP/Postal Code
6043 CV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cees de Vos, Dr.
Facility Name
Viecuri Medical Centre Northern Limburg
City
Venlo
State/Province
Limburg
ZIP/Postal Code
5912 BL
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Braim Rahel, Dr.
First Name & Middle Initial & Last Name & Degree
Joan Meeder, Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving the Accuracy of Referrals of Patients With Chest Pain
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