SpinChip Hs-cTnI Clinical Diagnostic Performance

Last updated: January 29, 2025
Sponsor: SpinChip Diagnostics ASA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Angina

Blood Clots

Treatment

SpinChip hs-cTnI

Clinical Study ID

NCT06499519
Design Protocol-02856
CIV-23-12-045095
  • Ages > 18
  • All Genders

Study Summary

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 evaluate the diagnostic accuracy and safety of the SpinChip hs-cTnI test relative to a clinically validated hs-cTnI method.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able and willing to provide signed written informed consent

  • Subjects ≥ 18 years old

  • Subjects presenting at the ED with acute chest discomfort including "pain", "pressure", "tightness", "burning", or "stabbing" and/or other symptoms suggestiveof AMI such as upper abdominal pain, left shoulder/arm pain, pain in the jaw, orpain between the scapulae.

Exclusion

Exclusion Criteria:

  • Subjects experiencing shock

  • Self-reported pregnancy

  • Previously included in the study (e.g., in case of a second presentation)

  • Patient incapable of judgement, for example due to severe pain

Study Design

Total Participants: 1200
Treatment Group(s): 1
Primary Treatment: SpinChip hs-cTnI
Phase:
Study Start date:
July 15, 2024
Estimated Completion Date:
July 01, 2025

Study Description

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 study is a multicentre, prospective, observational, non-randomised, open clinical performance study for evaluation of the diagnostic accuracy and safety of the SpinChip hs-cTnI test as an aid in the diagnosis of AMI. Subjects presenting with acute chest discomfort or other symptoms suggestive of AMI will be recruited at the emergency departments (EDs).

Connect with a study center

  • Aarhus Universitetshospital

    Aarhus, DK-8200
    Denmark

    Active - Recruiting

  • Universitätsmedizin Göttingen (University Medical Center Göttingen)

    Göttingen, 37099
    Germany

    Active - Recruiting

  • Akershus University hospital, Akershus Clinical Research Center (ACR)

    Lørenskog, Akerhus 1474
    Norway

    Active - Recruiting

  • Haukland University Hospital, Department of Heart Disease

    Bergen, Vestland 5021
    Norway

    Active - Recruiting

  • Danderyd University Hospital

    Danderyd, 182 88
    Sweden

    Active - Recruiting

  • University hospital Basel, Cardiovascular Research Institute of Basel (CRIB)

    Basel, 4056
    Switzerland

    Active - Recruiting

  • Luzerner Kantonsspital

    Luzern, 6000
    Switzerland

    Active - Recruiting

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SB
    United Kingdom

    Active - Recruiting

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