SpinChip Hs-cTnI Multisite Precision

Completed

• Conditions: Acute Myocardial Infarction (AMI)

• Registration Number: NCT06851013
• Lead Sponsor: SpinChip Diagnostics ASA

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.

Study Timeline

• Study Start: 2025-02-03
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-02-28
• Primary Completion: 2025-03-28
• Study Completion: 2025-03-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Precision of the SpinChip hs-cTnI test using Li-heparin plasma and whole blood samples	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 Outcome Measures

Name	Time	Method
Incidence of AEs, ADEs and DDs	1 day	Evaluate safety of the SpinChip Platform, as measured by adverse events (AEs), adverse device effects (ADEs) and device deficiencies (DDs).
Precision of the recommended commercially available control material	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

Trial Locations

Locations (3)

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

Vestre Viken Bærum Hospital; 🇳🇴 Sandvika, Akershus, Norway

SpinChip Diagnostics; 🇳🇴 Oslo, Norway