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

Primary Purpose

Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined risk score
Usual care
point-of-care troponin
Sponsored by
Catharina Ziekenhuis Eindhoven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring EMS, POC-troponin, Combined risk scores, Prehospital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients suspected for NSTE-ACS; Prospective study Original data Presenting prehospital (EMS) Prehospital risk assessment using at least POC-troponin, performed and analyzed by EMS. Outcome data available on in-hospital ACS or MACE within 30 days. Exclusion Criteria: Enrolling only a specific subpopulation from the general ACS population Studies with less than 100 patients Studies enrolling only patients with STEMI. Studies published before 1995 / the pre-troponin era Studies performed by general practitioners.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Usual care

    point-of-care troponin

    Combined risk scores

    Arm Description

    Patients who receive usual care by EMS protocols

    Patients in who risk-stratification was performed by the use of a point-of-care troponin in the EMS setting

    Patients in who risk-stratification was performed by the use of a combined risk score in the EMS setting

    Outcomes

    Primary Outcome Measures

    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)
    MACE
    All cause death, myocardial infarction, revascularization

    Secondary Outcome Measures

    MACE
    All cause death, myocardial infarction, revascularization
    All cause death
    The number of participants undergoing invasive coronary angiography
    The number of participants undergoing coronary revascularisation
    percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
    Alternative diagnoses other than NSTE-ACS
    If no NSTE-ACS is diagnosed, what is the alternative diagnosis (such as pulmonary embolism, aortic dissection, pneumothorax)
    Safety endpoints concerning intracoronary angiography and/or PCI
    Bleeding complications
    Safety endpoints concerning intracoronary angiography and/or PCI
    Contrast-induced nephropathy Possible or definite stent thrombosis Ischemic stroke Death
    Safety endpoints concerning intracoronary angiography and/or PCI
    Possible or definite stent thrombosis
    Safety endpoints concerning intracoronary angiography and/or PCI
    Ischemic stroke
    Safety endpoints concerning intracoronary angiography and/or PCI
    Death
    Health care utilization
    Number of ambulance transfers
    Health care utilization
    Duration of hospitalisation (days)
    Health care utilization
    Number of double invasive coronary angiography procedures
    Total health care costs

    Full Information

    First Posted
    September 4, 2023
    Last Updated
    September 18, 2023
    Sponsor
    Catharina Ziekenhuis Eindhoven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06051110
    Brief Title
    Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome
    Official Title
    Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Catharina Ziekenhuis Eindhoven

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
    Keywords
    EMS, POC-troponin, Combined risk scores, Prehospital

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    8000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual care
    Arm Type
    Other
    Arm Description
    Patients who receive usual care by EMS protocols
    Arm Title
    point-of-care troponin
    Arm Type
    Other
    Arm Description
    Patients in who risk-stratification was performed by the use of a point-of-care troponin in the EMS setting
    Arm Title
    Combined risk scores
    Arm Type
    Other
    Arm Description
    Patients in who risk-stratification was performed by the use of a combined risk score in the EMS setting
    Intervention Type
    Device
    Intervention Name(s)
    Combined risk score
    Intervention Description
    Prehospital risk stratification by the use of a combined clinical risk score including POC-troponin
    Intervention Type
    Other
    Intervention Name(s)
    Usual care
    Intervention Description
    Prehospital risk stratification by EMS protocols
    Intervention Type
    Device
    Intervention Name(s)
    point-of-care troponin
    Intervention Description
    Prehospital risk stratification by the use of a POC-troponin
    Primary Outcome Measure Information:
    Title
    Number of participants with the diagnosis NSTE-ACS
    Description
    Diagnosis of NSTE-ACS (NSTEMI or unstable AP) during index hospitalization (as assessed by the treating physician)
    Time Frame
    During index hospitalization, up to 1 day in the ED
    Title
    MACE
    Description
    All cause death, myocardial infarction, revascularization
    Time Frame
    Within 30 days
    Secondary Outcome Measure Information:
    Title
    MACE
    Description
    All cause death, myocardial infarction, revascularization
    Time Frame
    1 week
    Title
    All cause death
    Time Frame
    Within 30 days and 1 year follow-up
    Title
    The number of participants undergoing invasive coronary angiography
    Time Frame
    During or after index hospitalisation, up to 30 days
    Title
    The number of participants undergoing coronary revascularisation
    Description
    percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
    Time Frame
    During or after index hospitalisation, up to 30 days
    Title
    Alternative diagnoses other than NSTE-ACS
    Description
    If no NSTE-ACS is diagnosed, what is the alternative diagnosis (such as pulmonary embolism, aortic dissection, pneumothorax)
    Time Frame
    during 30 day follow-up after inclusion
    Title
    Safety endpoints concerning intracoronary angiography and/or PCI
    Description
    Bleeding complications
    Time Frame
    during 30 day follow-up after intracoronary angiography and/or PCI
    Title
    Safety endpoints concerning intracoronary angiography and/or PCI
    Description
    Contrast-induced nephropathy Possible or definite stent thrombosis Ischemic stroke Death
    Time Frame
    during 30 day follow-up after intracoronary angiography and/or PCI
    Title
    Safety endpoints concerning intracoronary angiography and/or PCI
    Description
    Possible or definite stent thrombosis
    Time Frame
    during 30 day follow-up after intracoronary angiography and/or PCI
    Title
    Safety endpoints concerning intracoronary angiography and/or PCI
    Description
    Ischemic stroke
    Time Frame
    during 30 day follow-up after intracoronary angiography and/or PCI
    Title
    Safety endpoints concerning intracoronary angiography and/or PCI
    Description
    Death
    Time Frame
    during 30 day follow-up after intracoronary angiography and/or PCI
    Title
    Health care utilization
    Description
    Number of ambulance transfers
    Time Frame
    Within 30 days after inclusion
    Title
    Health care utilization
    Description
    Duration of hospitalisation (days)
    Time Frame
    Up to 30 days after inclusion
    Title
    Health care utilization
    Description
    Number of double invasive coronary angiography procedures
    Time Frame
    Within 30 days after inclusion
    Title
    Total health care costs
    Time Frame
    At 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients suspected for NSTE-ACS; Prospective study Original data Presenting prehospital (EMS) Prehospital risk assessment using at least POC-troponin, performed and analyzed by EMS. Outcome data available on in-hospital ACS or MACE within 30 days. Exclusion Criteria: Enrolling only a specific subpopulation from the general ACS population Studies with less than 100 patients Studies enrolling only patients with STEMI. Studies published before 1995 / the pre-troponin era Studies performed by general practitioners.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pieter-Jan Vlaar, MD, PhD
    Phone
    040 239 9111
    Email
    pieter-jan.vlaar@catharinaziekenhuis.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pieter-Jan Vlaar, MD, PhD
    Organizational Affiliation
    Catharina Ziekenhuis Eindhoven
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    35383078
    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.
    Results Reference
    background
    PubMed Identifier
    34373266
    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.
    Results Reference
    background
    PubMed Identifier
    36755110
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34849660
    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.
    Results Reference
    background
    PubMed Identifier
    35863696
    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.
    Results Reference
    background

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

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