NCT04904107

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
852

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 4, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

May 11, 2021

Last Update Submit

June 9, 2022

Conditions

Chest PainAcute Coronary SyndromeMyocardial InfarctionMyocardial IschemiaHeart Attack

Keywords

Modified HEART scorePoint-of-care testingTroponinSiemens Healthineers

Outcome Measures

Primary Outcomes (2)

  • 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.

    30 days

  • 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.

    30 days, 6 months and 1 year

Secondary Outcomes (8)

  • The incidence of MACE in subgroups (percentage, %)

    30 days, 6 months and 1 year

  • The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED in subgroups (percentage, %)

    30 days, 6 months and 1 year

  • Cost-effectiveness analysis

    30 days, 6 months and 1 year

  • Assessment of the diagnostic value of the modified HEART score.

    30 days, 6 months and 1 year

  • Overview of the actual diagnosis of patients with a low modified HEART score (0-3).

    30 days

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Diagnostic Test: modified HEART score (including POC hs cTnI analysis)

Control group

ACTIVE COMPARATOR

Chest pain patients in the control group will receive standard triage and standard care according to the local (EMT) protocol.

Other: Standard care and triage according to the local (EMT)protocol.

Interventions

modified HEART score (including POC hs cTnI analysis)DIAGNOSTIC_TEST

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 group
Standard care and triage according to the local (EMT)protocol.OTHER

Standard care and triage of chest pain patients according to the local (EMT)protocol.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laurentius Hospital Roermond

Roermond, Limburg, 6043 CV, Netherlands

RECRUITING

Viecuri Medical Centre Northern Limburg

Venlo, Limburg, 5912 BL, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39806626DERIVED

MeSH Terms

Conditions

Chest PainAcute Coronary SyndromeMyocardial InfarctionMyocardial Ischemia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesNecrosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Braim Rahel, Dr.

    Viecuri Medical Centre Northern Limburg

    PRINCIPAL INVESTIGATOR

  • Joan Meeder, Dr.

    Viecuri Medical Centre Northern Limburg

    PRINCIPAL INVESTIGATOR

  • Cees de Vos, Dr.

    Laurentius Hospital Roermond

    PRINCIPAL INVESTIGATOR

  • Arnoud van 't Hof, Prof. dr.

    Zuyderland MC

    STUDY DIRECTOR

  • Robert Willemsen, Dr.

    General practitioner office Nazareth Maastricht

    STUDY DIRECTOR

Central Study Contacts

Lisa Frenk, Drs.

CONTACT

0031773205555lfrenk@viecuri.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
EMT personnel will be blinded for the randomisation sequence.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 27, 2021

Study Start

July 4, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2024

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)