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Completed

NCT Number: NCT06851013

SpinChip Hs-cTnI Multisite Precision

During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack. The SpinChip hs-cTnI test is a new high-sensitive test for measuring the amount of cardiac troponin I in the bloodstream as an aid in the diagnosis of heart attack.

The purpose of this study is to establish the precision of the SpinChip hs-cTnI test when using Li-Heparin plasma and whole blood samples in the hands of the intended user in the intended use setting at multiple sites.

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Key information

Conditions

Acute Myocardial Infarction (AMI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital, Akershus Clinical Research Center (ACR), Lørenskog, Akershus, Norway

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About this study

Cardiac troponins are widely used as a biomarker to aid in the diagnosis of acute myocardial infarction (AMI). These structural proteins are essential in regulating contraction in cardiac muscle cells, and they are sensitive and specific biochemical markers of myocardial damage.

During a heart attack, cardiac muscle cells are injured and release the cardiac marker troponin I (cTnI) into the bloodstream. High-sensitive troponin tests may detect the increase of cardiac troponin in blood within hours after the symptoms of a heart attack has started.

The SpinChip high-sensitivity cardiac troponin I (hs-cTnI) test is a new high-sensitive test for measuring troponin I in blood samples, and the analysis may be performed close to the patient (near-patient test). The results may be obtained within 10 minutes, compared to approximately 1 hour for normal laboratory analysis.

The SpinChip Platform consists of the SpinChip hs-cTnI test and the SpinChip Analyzer and may be used at the emergency department to evaluate patients presenting with symptoms of acute myocardial infarction (chest pain). The test can use blood from finger prick or venous blood samples, either as whole blood or separated into plasma.

This multisite prospective, observational, non-randomized validation study will establish the repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test for Li-Heparin plasma and repeatability for Li-Heparin whole blood samples. Potential subjects will be identified based on clinical cardiac troponin levels obtained from medical records at the individual study site.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able and willing to provide signed written informed consent
  • Subjects >18 years old
  • Clinical cTn concentrations available

Exclusion criteria

  • Cognitive impairment precluding informed consent
  • Self-reported pregnancy
  • General clinical condition that affects the patient in a major way and the patient is considered to be in an unstable clinical condition
  • Previously included in the study with a sample within the required concentration ranges for the SpinChip hs-cTnI test
  • No venous blood sample collected for the study

Treatment and study plan

SpinChip hs-cTnI

Diagnostic Test

SpinChip Platform, consisting of the SpinChip hs-cTnI test (self-contained cartridge) and SpinChip Analyzer (instrument)

Primary outcomes

  1. Precision of the SpinChip hs-cTnI test using Li-heparin plasma and whole blood samples

    Time frame: 1 day

    Calculation of repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin plasma. Calculation of repeatability of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin whole blood.

Secondary outcomes

  1. Precision of the recommended commercially available control material

    Time frame: 1 day

    Calculation of repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test using cTnI results obtained from analysis of commercial control material

  2. Incidence of AEs, ADEs and DDs

    Time frame: 1 day

    Evaluate safety of the SpinChip Platform, as measured by adverse events (AEs), adverse device effects (ADEs) and device deficiencies (DDs).

Sponsors and collaborators

Lead sponsor

SpinChip Diagnostics ASA

Industry

Collaborators

  • Aurevia

Registry information

Official study title

Multisite Precision Study for the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test

Acronym: HEAT-1

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
May 14, 2025

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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