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

• Sponsor: Catharina Ziekenhuis Eindhoven (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06051110
• Collaborator: (none)
• Enrollment: 8,000
• Arms: 3
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; Non ST Segment Elevation Acute Coronary Syndrome	Device: Combined risk score; Other: Usual care; Device: point-of-care troponin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8000 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Usual care Patients who receive usual care by EMS protocols	Other: Usual care; Prehospital risk stratification by EMS protocols
Other: point-of-care troponin Patients in who risk-stratification was performed by the use of a point-of-care troponin in the EMS setting	Device: point-of-care troponin; Prehospital risk stratification by the use of a POC-troponin
Other: Combined risk scores Patients in who risk-stratification was performed by the use of a combined risk score in the EMS setting	Device: Combined risk score; Prehospital risk stratification by the use of a combined clinical risk score including POC-troponin

Outcome Measures

Primary Outcome Measures

1. Number of participants with the diagnosis NSTE-ACS [During index hospitalization, up to 1 day in the ED]

   Diagnosis of NSTE-ACS (NSTEMI or unstable AP) during index hospitalization (as assessed by the treating physician)

2. MACE [Within 30 days]

   All cause death, myocardial infarction, revascularization

Secondary Outcome Measures

1. MACE [1 week]

   All cause death, myocardial infarction, revascularization

2. All cause death [Within 30 days and 1 year follow-up]

3. The number of participants undergoing invasive coronary angiography [During or after index hospitalisation, up to 30 days]

4. The number of participants undergoing coronary revascularisation [During or after index hospitalisation, up to 30 days]

   percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)

5. Alternative diagnoses other than NSTE-ACS [during 30 day follow-up after inclusion]

   If no NSTE-ACS is diagnosed, what is the alternative diagnosis (such as pulmonary embolism, aortic dissection, pneumothorax)

6. Safety endpoints concerning intracoronary angiography and/or PCI [during 30 day follow-up after intracoronary angiography and/or PCI]

   Bleeding complications

7. Safety endpoints concerning intracoronary angiography and/or PCI [during 30 day follow-up after intracoronary angiography and/or PCI]

   Contrast-induced nephropathy Possible or definite stent thrombosis Ischemic stroke Death

8. Safety endpoints concerning intracoronary angiography and/or PCI [during 30 day follow-up after intracoronary angiography and/or PCI]

   Possible or definite stent thrombosis

9. Safety endpoints concerning intracoronary angiography and/or PCI [during 30 day follow-up after intracoronary angiography and/or PCI]

   Ischemic stroke

10. Safety endpoints concerning intracoronary angiography and/or PCI [during 30 day follow-up after intracoronary angiography and/or PCI]

    Death

11. Health care utilization [Within 30 days after inclusion]

    Number of ambulance transfers

12. Health care utilization [Up to 30 days after inclusion]

    Duration of hospitalisation (days)

13. Health care utilization [Within 30 days after inclusion]

    Number of double invasive coronary angiography procedures

14. Total health care costs [At 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Catharina Ziekenhuis Eindhoven

Investigators

• Principal Investigator: Pieter-Jan Vlaar, MD, PhD, Catharina Ziekenhuis Eindhoven

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Pieter-Jan Vlaar, Principal Investigator, Catharina Ziekenhuis Eindhoven
• ClinicalTrials.gov Identifier: NCT06051110
• Other Study ID Numbers: nWMO-2023.086
• First Posted: Sep 22, 2023
• Last Update Posted: Sep 22, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pieter-Jan Vlaar, Principal Investigator, Catharina Ziekenhuis Eindhoven: EMS; POC-troponin; Combined risk scores; Prehospital
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome

Study Results

No Results Posted as of Sep 22, 2023