SpinChip Hs-cTnI Multisite Precision

NCT ID: NCT06851013

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2025-03-28

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.

Conditions

Acute Myocardial Infarction (AMI)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

SpinChip hs-cTnI

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aurevia

INDUSTRY

Sponsor Role: collaborator

SpinChip Diagnostics ASA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hlge Røsjø, MD/Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Akershus University Hospital, Akershus Clinical Research Center (ACR)

Lørenskog, Akershus, Norway

Vestre Viken Bærum Hospital

Sandvika, Akershus, Norway

SpinChip Diagnostics

Oslo, Oslo County, Norway

Countries

Norway

Other Identifiers

CIV-NO-24-09-049195

Identifier Type: OTHER

Identifier Source: secondary_id

Design Protocol-03821

Identifier Type: -

Identifier Source: org_study_id