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Completed

NCT Number: NCT04153006

Comparison of Fingerstick Versus Venous Sample for Troponin I.

This study is a prospective, observational, cohort study aiming to compare point-of-care high-sensitive troponin I testing from different sample types with central laboratory (CL) HS cTnI plasma samples.

A registry of all included patients and their troponin results (POC, CL and HS cTnT) will be made to compare these testing methods.

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Key information

Conditions

Chest Pain Cardiovascular Diseases Heart Attack Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Viecuri MC

Venlo, Limburg, 5912 BL, Netherlands

About this study

Point-of-care (POC) troponin testing, defined as laboratory testing near a patient location with rapid availability of results, has attracted much interest in the emergency department setting (ED) and seems feasible. These devices might enable earlier decisions, reduce stay at the ED and improve patient flow. While an elevated troponin in patients with suspected acute coronary syndrome (ACS) confirms diagnosis and initiates adequate treatment, ruling out ACS aids in proper patient dismissal. A next step could be ruling out myocardial infarction by the general practitioner (GP) or fast responder using an on-site POC troponin test. However, drawing venous blood might not be easily available to every GP, especially not during peak hours. The Minicare cTnI is a bedside system which requires capillary blood, venous whole blood or plasma. The results of the troponin will be given within 10 minutes. It is a very sensitive troponin test, the most clinically sensitive available POC for c-Troponin. Currently Minicare prepares for a high sensitive troponin analysis targeting a reliable result within an hour after onset of chest pain. The objective of this study is to determine if high sensitive troponin testing by Minicare (POC HS cTnI) has the same analytical performance as standard high sensitivity troponin I testing in our central hospital laboratory ( CL HS cTnI ARCHITECT immunoassay analyzer, Abbott).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years or older with chest pain suspected of ACS.

Exclusion criteria

  • ST elevation myocardial infarction and out of hospital cardiac arrest.
  • Patients with sudden onset tachycardia and a frequency of 110 bpm or higher (supraventricular or ventricular)
  • Patients who are hemodynamically unstable or in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.
  • Patients recently already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site.
  • Patients not willing or not able to provide informed consent due to their medical condition as judged by the physician.

Treatment and study plan

POC troponin analysis.

Device

Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Minicare® device.

Primary outcomes

  1. Method and sample comparison

    Time frame: 30 days

    The primary objective is to compare the analytical performance (method and sample comparison) of Minicare® high sensitive troponin I testing (POC, different sample types) and conventional venipuncture troponin I test in our central hospital laboratory (CL) with the Abbott Architect.

    This comparison will comprise:

    • Minicare® POC (different sample types) vs conventional HS cTnI CL test (Method comparison)
    • Minicare® capillary vs. Minicare® venipuncture and vs. Minicare® plasma (Sample comparison)

    The analyses linked to the primary objectives are:

    • The agreement between POC (three sample types) and CL testing by using the Bland-Altman method.
    • The agreement between different POC sample types by using the Bland-Altman method.

    The primary objective will be achieved by taking capillary and (an extra) venous blood samples (one per timepoint) from every patient presenting at the cardiac ED with chest pain suspected for ACS.

Secondary outcomes

  1. Major adverse cardiac event (MACE)

    Time frame: 30 days

    MACE is is defined as a composite of cardiac death and myocardial infarction.

  2. Final patients diagnoses.

    Time frame: 30 days

    To compare final patients diagnosis (ACS vs. no ACS) and treatment based on POC venous troponin testing versus CL plasma troponin I testing versus HS cTnT plasma testing (regular patient care).

  3. Overview baseline characteristics.

    Time frame: 30 days

    To create an overview of baseline characteristics of the population.

  4. Linear regression and Pearson's correlation.

    Time frame: 30 days

    • The relationship between POC (three sample types) and CL by linear regression and Pearson's correlation.
    • The relationship between POC sample types by linear regression and Pearson's correlation.

  5. Fals-positive and fals-negatives.

    Time frame: 30 days

    To compare the proportion of false positive and false negative results between the different POC samples and if there is a significant difference.

  6. Safety analysis of POC troponin.

    Time frame: 30 days

    To create an overview of the sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of POC and standard laboratory troponin I testing.

Sponsors and collaborators

Lead sponsor

VieCuri Medical Centre

Other

Collaborators

  • Minicare® B.V.
  • Siemens Healthcare Diagnostics Inc

Registry information

Official study title

Sample and Method Comparison With Minicare® Point-of-care Device for Cardiac Troponin I Assay at the Emergency Department.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2019
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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