SpinChip Hs-cTnI Multisite Precision

NCT06851013 | Completed

• 2 other identifiers: Design Protocol-03821CIV-NO-24-09-049195
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Acute Myocardial Infarction; High-sensitive; Point of care; Troponin I; Near-patient test; Heart attack; Diagnostic accuracy

Outcome Measures

Primary Outcomes (1)

• Precision of the SpinChip hs-cTnI test using Li-heparin plasma and whole blood samples

  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.

  1 day

Secondary Outcomes (2)

• Precision of the recommended commercially available control material

  1 day

• Incidence of AEs, ADEs and DDs

  1 day

Interventions

SpinChip hs-cTnI DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Able and willing to provide signed written informed consent
• Subjects \>18 years old
• Clinical cTn concentrations available

You may not qualify if:

• 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

Sponsors & Collaborators

• SpinChip Diagnostics ASA: lead
• Aurevia: collaborator

Study Sites (3)

Akershus University Hospital, Akershus Clinical Research Center (ACR)

Lørenskog, Akershus, 1478, Norway

Location

Vestre Viken Bærum Hospital

Sandvika, Akershus, 1346, Norway

Location

SpinChip Diagnostics

Oslo, Oslo County, 0275, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Li-heparin plasma

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Hlge Røsjø, MD/Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 28, 2025
• Study Start: February 3, 2025
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)