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)

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) - Improving the accuracy of referrals of patients with chest pain.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55210

Enrollment

852

Registered

2021-04-14

Start date

2021-07-02

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute coronary syndrome heart attack

Interventions

Modified HEART score evaluation for analysing the risk of acute coronary syndrome.

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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 100 and peripheral oxygen saturation

Design outcomes

Primary

Measure	Time frame
The primary objective is referring patients with ACS more promptly to the cardiac ED and ruling out ACS in patients with NCCP without referral. We aim to evaluate the percentual reduction of unnecessary referred patients (patients admitted to the cardiac ED with NCCP) in comparison to our control group.	—

Secondary

Measure	Time frame
The secondary objectives are: 1. An overview of the baseline characteristics of the study population including signs and symptoms at inclusion. 2. A comparison of the baseline characteristics, signs, and symptoms in the intervention versus control group. 3. An overview of the patients in the URGENT 2.0 intervention group with a modified HEART score 0-3 (low risk) and the cause of chest pain. 4. An overview of the patients in the URGENT 2.0 intervention group with a modified HEART score >3 (moderate-high risk) and the cause of chest pain. 5. An overview of the patients in the URGENT 2.0 intervention group with a modified HEART score 0-3 but eventually a cardiac origin for their complaints (diagnosed at the cardiac ED) 6. 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. 7. 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 after initial presentation in the intervention group versus control group. 8. Subgroup analyses for patients with diabetes mellitus. 9. Subgroup analyses for gender differences. 10. Subgroup analyses for type of referral (GP vs. triage nurse GPC vs. self-referral). 11. Clinical accuracy (Positive Predictive value) of POC Hs cTnI assessment versus HS cTnT at the cardiac ED. 12. To evaluate the possible medical costs reduction in the URGENT 2.0 patients and comparison with the control group. 13. Time elapsed from arrival EMT at patient*s home to arrival at ED in intervention group versus control group.	—

Measure

Time frame

The secondary objectives are: 1. An overview of the baseline characteristics of the study population including signs and symptoms at inclusion. 2. A comparison of the baseline characteristics, signs, and symptoms in the intervention versus control group. 3. An overview of the patients in the URGENT 2.0 intervention group with a modified HEART score 0-3 (low risk) and the cause of chest pain. 4. An overview of the patients in the URGENT 2.0 intervention group with a modified HEART score >3 (moderate-high risk) and the cause of chest pain. 5. An overview of the patients in the URGENT 2.0 intervention group with a modified HEART score 0-3 but eventually a cardiac origin for their complaints (diagnosed at the cardiac ED) 6. 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. 7. 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 after initial presentation in the intervention group versus control group. 8. Subgroup analyses for patients with diabetes mellitus. 9. Subgroup analyses for gender differences. 10. Subgroup analyses for type of referral (GP vs. triage nurse GPC vs. self-referral). 11. Clinical accuracy (Positive Predictive value) of POC Hs cTnI assessment versus HS cTnT at the cardiac ED. 12. To evaluate the possible medical costs reduction in the URGENT 2.0 patients and comparison with the control group. 13. Time elapsed from arrival EMT at patient*s home to arrival at ED in intervention group versus control group.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)