Pre-hOspital Evaluation of Chest Pain Patients With sUspected Non ST-segment eLevation myocARdial Infarction Using the HEART-score With a Troponin Point-of-care Test
POPular HEART
1 other identifier
observational
650
1 country
2
Brief Summary
Overcrowding in the emergency department is an increasing problem in hospitals worldwide. Point-of-care Troponin (POC cTn) testing combined with a well investigated risk stratification tool (HEART-score) used in the ambulance may contribute to more rapidly diagnostics of ruling in or ruling out myocardial infarctions (MI) and subsequently reduce unnecessary hospital admissions, total admission time and costs. However, the applicability of the POC cTn and the HEART-score in the pre-hospital setting remains unclear. This study will evaluate this applicability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 12, 2021
CompletedFirst Posted
Study publicly available on registry
April 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedApril 20, 2021
April 1, 2021
1.3 years
April 12, 2021
April 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Heart score agreement
HEART-score agreement (interobserver variability between pre-hospital and in-hospital HEART-score assessment): the calculated heart score by the ambulance will be subtracted from the calculated score of the emergency department. The minimum value could be -10 and the maximum value could be +10. A positive score means that the ambulance estimates the patient to be sicker or at higher risk. A negative value means that the ED estimates the patient to be sicker/at higher risk for developing major adverse cardiac events.
1 year
Number of participants with final diagnosis of NSTE-ACS
final diagnosis of NSTE-ACS (non-ST elevation myocardial infarction and unstable angina pectoris) at discharge
1 year
Number of participants with final diagnosis of myocardial infarction at discharge
Myocardial infarction at discharge
1 year
Secondary Outcomes (3)
Number of participants with a composite endpoint
30 days
Patient reported outcome measure: Seattle Angina questionnaire (SAQ)
30 days
Patient reported outcome measure: Patient Health Questionnaire 4
30 days
Study Arms (1)
Possible NSTE-ACS
All patients with a suspicion of non-ST-elevation acute coronary syndrome (NSTE-ACS) in the pre-hospital phase are eligible for inclusion. In all included patients, the POC cTn will be performed and the HEART-score will be calculated in the pre-hospital phase. Simultaneously, a venous blood sample will be drawn from the venous access site for later hs-cTn testing. Outcomes of both the POC cTn or the pre-hospital HEART-score will be blinded for the physicians at the emergency department (ED) and will not affect current treatment strategy. All patients with suspected NSTE-ACS will undergo hs-cTn testing and the HEART-score will also be calculated at the ED (T1, standard of care). Here, an additional venous blood sample will be drawn next to routine blood testing testing (T1).
Interventions
As mentioned in the group description
Eligibility Criteria
Patients with suspected acute coronary syndrome. Total number of patients needed for analysis: n=650
You may qualify if:
- All out-of-hospital chest pain patients visited by an ambulance
- Transportation to a hospital with working diagnosis NSTE-ACS
- Age ≥ 18 years
You may not qualify if:
- Comatose state, hemodynamic instability or shock
- Electrocardiographic ST-segment elevation in the pre-hospital setting
- No pre-hospital 12-lead electrocardiogram performed or available
- An obvious non-cardiac cause for the chest pain (trauma, etc.)
- Suspicion of aortic dissection or pulmonary embolism
- Cognitive impairment
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Antonius Hospitallead
- Diakonessenhuis, Utrechtcollaborator
- Abbottcollaborator
Study Sites (2)
St Antonius Hospital
Nieuwegein, 3435CL, Netherlands
Diakonessenhuis Utrecht
Utrecht, 3582KE, Netherlands
Related Publications (1)
Azzahhafi J, Chan Pin Yin DR, Epping M, Bofarid H, Rikken SA, Verhagen T, Boomars R, Radstok A, Houtgraaf J, Bikker A, Ten Berg JM. Pre-hospital evaluation of chest pain patients using the modified HEART-score: rationale and design. Future Cardiol. 2024 Apr 25;20(5-6):241-250. doi: 10.1080/14796678.2024.2356995. Epub 2024 Jun 28.
PMID: 38940186DERIVED
Biospecimen
two venous blood samples will be drawn in the pre-hospital phase. One will be used for high-sensitive troponin measure in the pre-hospital phase (at the resident of the patient). The second one will be used to validate the point-of-care measurement with the troponin value in the laboratory.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
HJ Houtgraaf, Dr.
Diakonessenhuis, Utrecht
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. J.M. ten Berg
Study Record Dates
First Submitted
April 12, 2021
First Posted
April 20, 2021
Study Start
September 1, 2020
Primary Completion
January 1, 2022
Study Completion
February 1, 2022
Last Updated
April 20, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share
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