Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06051110
• Other study ID #: nWMO-2023.086
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Catharina Ziekenhuis Eindhoven
• Contact: Pieter-Jan Vlaar, MD, PhD
• Phone: 040 239 9111
• Email: pieter-jan.vlaar[@]catharinaziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) are currently transported and admitted to the nearest emergency department (ED) for risk stratification, diagnostic workup, and treatment. Recently, several prospective studies have been performed on the diagnostic performance of point-of-care (POC)-troponin and combined risk scores (CRS) for pre-hospital risk assessment and triage of NSTE-ACS patients. Also the first intervention trials on triage decisions based on POC troponin and CRS have been performed. Initial results are indicating that prehospital triage based on these diagnostic tools is feasible and safe, although sample sizes were relatively small and underpowered to detect differences in major adverse cardiac events (MACE). The objective of this individual patient data meta-analysis is to determine the diagnostic performance of POC troponin and combined risk scores for prehospital risk assessment and triage in suspected NSTE-ACS patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: October 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients suspected for NSTE-ACS;

2. Prospective study

3. Original data

4. Presenting prehospital (EMS)

5. Prehospital risk assessment using at least POC-troponin, performed and analyzed by EMS.

6. Outcome data available on in-hospital ACS or MACE within 30 days.

Exclusion Criteria:

1. Enrolling only a specific subpopulation from the general ACS population

2. Studies with less than 100 patients

3. Studies enrolling only patients with STEMI.

4. Studies published before 1995 / the pre-troponin era

5. Studies performed by general practitioners.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Non ST Segment Elevation Acute Coronary Syndrome
• Syndrome

Intervention

Device:
• Combined risk score
Prehospital risk stratification by the use of a combined clinical risk score including POC-troponin

Other:
• Usual care
Prehospital risk stratification by EMS protocols

Device:
• point-of-care troponin
Prehospital risk stratification by the use of a POC-troponin

Locations

Country	Name	City	State
Netherlands	Catharina hospital Eindhoven	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

Camaro C, Aarts GWA, Adang EMM, van Hout R, Brok G, Hoare A, Rodwell L, de Pooter F, de Wit W, Cramer GE, van Kimmenade RRJ, Damman P, Ouwendijk E, Rutten M, Zegers E, van Geuns RM, Gomes MER, van Royen N. Rule-out of non-ST-segment elevation acute coronary syndrome by a single, pre-hospital troponin measurement: a randomized trial. Eur Heart J. 2023 May 14;44(19):1705-1714. doi: 10.1093/eurheartj/ehad056. — View Citation

Demandt JPA, Koks A, Haest R, Heijmen E, Thijssen E, Otterspoor LC, van Veghel D, El Farissi M, Eerdekens R, Vervaat F, Pijls NHJ, Veer MVT, Tonino PAL, Dekker LRC, Vlaar PJ. Prehospital triage of patients with suspected non-ST-segment elevation acute coronary syndrome: Rationale and design of the TRIAGE-ACS study. Contemp Clin Trials. 2022 Aug;119:106854. doi: 10.1016/j.cct.2022.106854. Epub 2022 Jul 18. — View Citation

Demandt JPA, Zelis JM, Koks A, Smits GHJM, van der Harst P, Tonino PAL, Dekker LRC, van Het Veer M, Vlaar PJ. Prehospital risk assessment in patients suspected of non-ST-segment elevation acute coronary syndrome: a systematic review and meta-analysis. BMJ Open. 2022 Apr 5;12(4):e057305. doi: 10.1136/bmjopen-2021-057305. — View Citation

Sagel D, Vlaar PJ, van Roosmalen R, Waardenburg I, Nieuwland W, Lettinga R, van Barneveld R, Jorna E, Kijlstra R, van Well C, Oomen A, Bartels L, Anthonio R, Hagens V, Hofma S, Gu Y, Drenth D, Addink R, van Asselt T, van der Meer P, Lipsic E, Juarez Orozco L, van der Harst P. Prehospital risk stratification in patients with chest pain. Emerg Med J. 2021 Nov;38(11):814-819. doi: 10.1136/emermed-2020-210212. Epub 2021 Aug 9. — View Citation

Tolsma RT, Fokkert MJ, van Dongen DN, Badings EA, van der Sluis A, Slingerland RJ, van 't Riet E, Ottervanger JP, van 't Hof AWJ. Referral decisions based on a pre-hospital HEART score in suspected non-ST-elevation acute coronary syndrome: final results of the FamouS Triage study. Eur Heart J Acute Cardiovasc Care. 2022 Feb 8;11(2):160-169. doi: 10.1093/ehjacc/zuab109. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with the diagnosis NSTE-ACS	Diagnosis of NSTE-ACS (NSTEMI or unstable AP) during index hospitalization (as assessed by the treating physician)	During index hospitalization, up to 1 day in the ED
Primary	MACE	All cause death, myocardial infarction, revascularization	Within 30 days
Secondary	MACE	All cause death, myocardial infarction, revascularization	1 week
Secondary	All cause death		Within 30 days and 1 year follow-up
Secondary	The number of participants undergoing invasive coronary angiography		During or after index hospitalisation, up to 30 days
Secondary	The number of participants undergoing coronary revascularisation	percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)	During or after index hospitalisation, up to 30 days
Secondary	Alternative diagnoses other than NSTE-ACS	If no NSTE-ACS is diagnosed, what is the alternative diagnosis (such as pulmonary embolism, aortic dissection, pneumothorax)	during 30 day follow-up after inclusion
Secondary	Safety endpoints concerning intracoronary angiography and/or PCI	Bleeding complications	during 30 day follow-up after intracoronary angiography and/or PCI
Secondary	Safety endpoints concerning intracoronary angiography and/or PCI	Contrast-induced nephropathy Possible or definite stent thrombosis Ischemic stroke Death	during 30 day follow-up after intracoronary angiography and/or PCI
Secondary	Safety endpoints concerning intracoronary angiography and/or PCI	Possible or definite stent thrombosis	during 30 day follow-up after intracoronary angiography and/or PCI
Secondary	Safety endpoints concerning intracoronary angiography and/or PCI	Ischemic stroke	during 30 day follow-up after intracoronary angiography and/or PCI
Secondary	Safety endpoints concerning intracoronary angiography and/or PCI	Death	during 30 day follow-up after intracoronary angiography and/or PCI
Secondary	Health care utilization	Number of ambulance transfers	Within 30 days after inclusion
Secondary	Health care utilization	Duration of hospitalisation (days)	Up to 30 days after inclusion
Secondary	Health care utilization	Number of double invasive coronary angiography procedures	Within 30 days after inclusion
Secondary	Total health care costs		At 30 days