Skip to main content
OpenTrials
Completed

NCT Number: NCT06499519

SpinChip Hs-cTnI Clinical Diagnostic Performance

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myocardial Infarction 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

Aarhus Universitetshospital, Aarhus, Denmark

Loading trial locations.

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 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).

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

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

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. Area under the receiver operating characteristics (AUROC) curve for cTnI concentrations measured at admission to the emergency department (ED)

    Time frame: Day of admission

    Calculate and compare the area under the curve (AUC) for both SpinChip hs-cTnI and clinically validated hs-cTnI method using centrally adjudicated diagnosis of AMI

Secondary outcomes

  1. AUROC for cTnI concentrations measured at 1, 2 and 3 hours after admission to the ED

    Time frame: Day of admission

    Calculate and compare the area under the curve (AUC) for both SpinChip hs-cTnI and clinically validated hs-cTnI method using centrally adjudicated diagnosis of AMI for the given timepoints

  2. Negative predictive value (NPV) at 0, 1, 2, and 3 hours after admission to the ED using the 99th percentile upper reference limit as clinical cut-off

    Time frame: Day of admission

    NPV is defined as the proportion of subjects with measured cTnI concentrations below a clinical cut-off value, who are correctly diagnosed as not having MI.

    The NPVs of the SpinChip hs-cTnI test will be calculated for 0, 1, 2, and 3 hours timepoints, using the overall and sex-specific 99th percentile upper reference limits as clinical cut-offs.

  3. Positive predictive value (PPV) at 0, 1, 2, and 3 hours after admission to the ED using the 99th percentile upper reference limit as clinical cut-off

    Time frame: Day of admission

    PPV is defined as the proportion of subjects with measured cTnI concentrations above a clinical cut-off value, who are diagnosed with MI.

    The PPV of the SpinChip hs-cTnI test will be calculated for cTnI concentrations obtained 0, 1, 2, and 3 hours timepoints, using the overall and sex-specific 99th percentile URL as clinical cut-offs.

  4. Occurrence of MI and/or cardiovascular death (CV) within 30 days

    Time frame: 30 days

    Prognostic accuracy for risk of MI/CV death for 30 days evaluated using Kaplan-Meier plots

    Cox proportional hazard model will be used to evaluate the prognostic performance of the SpinChip hs-cTnI test for outcomes MI and CV death within 30 days.

  5. Derivation and validation of rule-in/rule-out 0/1h and 0/2h algorithms

    Time frame: Day of admission

    Rule-in/rule-out algorithms will be calculated in accordance with the European Society of Cardiology (ESC) rapid rule-in/rule-out protocols for cTnI results obtained at admission (0h) and 1 hours, as well as 0 h and 2 hours after admission. The rule-out limit will be derived so that the sensitivity and NPV is > 99%, and rule-in limit so that the diagnostic specificity and PPV is > 70% using 60% of the study population. The derived rule-out and rule-in limits will be validated using a remaining population.

  6. Incidence of AEs, ADEs and DDs

    Time frame: Day of admission

    Assess the 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

Clinical Diagnostic Performance of the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test

Acronym: HEAT-4

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2024
Registry last updated
Jan 26, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.