Clinical trial NCT06851013: SpinChip Hs-cTnI Multisite Precision
Official title: Multisite Precision Study for the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction (AMI)
Keywords: Acute Myocardial Infarction
High-sensitive
Point of care
Troponin I
Near-patient test
Heart attack
Diagnostic accuracy
Lead sponsor: SpinChip Diagnostics ASA
Sponsor class: INDUSTRY
Collaborators: name: Aurevia
First posted: 2025-02-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized, adult subjects with known cTn values obtained from medical records. The study population will be recruited from two clinical sites in Norway.

Brief 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 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.

Detailed 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Precision of the SpinChip hs-cTnI test using Li-heparin plasma and whole blood samples
timeFrame: 1 day
Secondary outcomes:
measure: Precision of the recommended commercially available control material
timeFrame: 1 day
measure: Incidence of AEs, ADEs and DDs
timeFrame: 1 day
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital, Akershus Clinical Research Center (ACR)
state: Akershus
city: Sandvika
country: Norway
facility: Vestre Viken Bærum Hospital
state: Akershus
city: Oslo
country: Norway
facility: SpinChip Diagnostics
Study officials:
affiliation: Akershus University Hospital, Akershus Clinical Research Center (ACR), Norway
name: Hlge Røsjø, MD/Professor
role: PRINCIPAL_INVESTIGATOR
References: