Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT04851418
Status:
UNKNOWN
Last Update Posted:
2021-04-20
First Post:
2021-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
St. Antonius Hospital
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPular HEART
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.
Detailed Description:
Co-primary Objectives:
1. To evaluate the interobserver agreement of the HEART-score performed by ambulance personnel compared to the HEART-score performed by emergency physicians.
2. To evaluate the diagnostic performance of a strategy based on a pre-hospital HEART-score (with POC cTn testing) or combined with an adjuvant single hs-cTn test at the emergency department to rule-in or rule-out acute coronary syndrome (ACS).
3. To evaluate the diagnostic performance of (serial) POC cTn testing or combined with hs-cTn testing compared to (serial) hs-cTn testing to rule-in or rule-out MI.
4. To investigate the feasibility of using the pre-hospital HEART-score and POC cTn in the 0/1 hour algorithm to rule-out ACS.
Secondary Objectives:
5. To evaluate the occurrence of major adverse cardiac events (MACE) in all included patients with a follow up time of 30 days from first medical contact.
6. To evaluate the patient reported outcome measures (PROMs) in all chest pain patients transported to the hospital at baseline and at 30 days
7. To perform a cost-analysis of an early diagnostic strategy using the pre-hospital HEART-score
Study design: A prospective, observational, single multicentre study Study population: Total number of patients needed for analysis: n=650 Inclusion criteria: - All out-of-hospital chest pain patients visited by an ambulance
* Transportation to a hospital with working diagnosis NSTE-ACS
* Age ≥ 18 years Exclusion criteria: - Comatose state, hemodynamic instability or shock
* Electrocardiographic ST-segment elevation in the pre-hospital setting treated as STEMI
* 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
* Suspicion of COVID-19 by ambulance
Study procedures: The HEART-score and the POC cTn will be calculated in all included patients 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 any pre-hospital study measurements (i.e. pre-hospital POC cTn results or calculated pre-hospital HEART-scores) are blinded to the physicians at the ED and will not affect usual care. According to current practice, all patients will be transported to the hospital for further evaluation. At the emergency department (ED) all included patients will undergo regular hs-cTn testing and HEART-score assessment performed by emergency physicians (standard care), and an extra venous blood sample will be drawn for this study. Additional cTn tests (POC and hs-cTn) will be performed in the laboratory.
Main study parameters/endpoints:
1. HEART-score agreement (interobserver variability between pre-hospital and in-hospital HEART-score assessment)
2. Final diagnosis of NSTE-ACS at discharge
3. Myocardial infarction at discharge
Secondary study parameters/endpoints:
4. Composite endpoint (cardiovascular mortality, myocardial infarction, urgent revascularisation) at 30 days
5. Angina frequency and stability, physical limitations, treatment satisfaction, quality-of-life, cardiac anxiety and depression (SAQ, PHQ-4)
Follow-up: Total follow-up duration is 30 days after initial presentation. Other demographic and clinical parameters at baseline will be taken into account.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will undergo a POC cTn test performed by ambulance personnel. In all patients, two venous blood samples will be drawn in the pre-hospital phase (1x) and at the emergency department (1x). Besides the minimal risks of performing a POC finger prick test, no other risks are involved with study participation. All patients will be asked to fill in questionnaires (i.e. SAQ, PHQ-4) at baseline and at follow-up.
1. To evaluate the interobserver agreement of the HEART-score performed by ambulance personnel compared to the HEART-score performed by emergency physicians.
2. To evaluate the diagnostic performance of a strategy based on a pre-hospital HEART-score (with POC cTn testing) or combined with an adjuvant single hs-cTn test at the emergency department to rule-in or rule-out acute coronary syndrome (ACS).
3. To evaluate the diagnostic performance of (serial) POC cTn testing or combined with hs-cTn testing compared to (serial) hs-cTn testing to rule-in or rule-out MI.
4. To investigate the feasibility of using the pre-hospital HEART-score and POC cTn in the 0/1 hour algorithm to rule-out ACS.
Secondary Objectives:
5. To evaluate the occurrence of major adverse cardiac events (MACE) in all included patients with a follow up time of 30 days from first medical contact.
6. To evaluate the patient reported outcome measures (PROMs) in all chest pain patients transported to the hospital at baseline and at 30 days
7. To perform a cost-analysis of an early diagnostic strategy using the pre-hospital HEART-score
Study design: A prospective, observational, single multicentre study Study population: Total number of patients needed for analysis: n=650 Inclusion criteria: - All out-of-hospital chest pain patients visited by an ambulance
* Transportation to a hospital with working diagnosis NSTE-ACS
* Age ≥ 18 years Exclusion criteria: - Comatose state, hemodynamic instability or shock
* Electrocardiographic ST-segment elevation in the pre-hospital setting treated as STEMI
* 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
* Suspicion of COVID-19 by ambulance
Study procedures: The HEART-score and the POC cTn will be calculated in all included patients 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 any pre-hospital study measurements (i.e. pre-hospital POC cTn results or calculated pre-hospital HEART-scores) are blinded to the physicians at the ED and will not affect usual care. According to current practice, all patients will be transported to the hospital for further evaluation. At the emergency department (ED) all included patients will undergo regular hs-cTn testing and HEART-score assessment performed by emergency physicians (standard care), and an extra venous blood sample will be drawn for this study. Additional cTn tests (POC and hs-cTn) will be performed in the laboratory.
Main study parameters/endpoints:
1. HEART-score agreement (interobserver variability between pre-hospital and in-hospital HEART-score assessment)
2. Final diagnosis of NSTE-ACS at discharge
3. Myocardial infarction at discharge
Secondary study parameters/endpoints:
4. Composite endpoint (cardiovascular mortality, myocardial infarction, urgent revascularisation) at 30 days
5. Angina frequency and stability, physical limitations, treatment satisfaction, quality-of-life, cardiac anxiety and depression (SAQ, PHQ-4)
Follow-up: Total follow-up duration is 30 days after initial presentation. Other demographic and clinical parameters at baseline will be taken into account.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will undergo a POC cTn test performed by ambulance personnel. In all patients, two venous blood samples will be drawn in the pre-hospital phase (1x) and at the emergency department (1x). Besides the minimal risks of performing a POC finger prick test, no other risks are involved with study participation. All patients will be asked to fill in questionnaires (i.e. SAQ, PHQ-4) at baseline and at follow-up.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: