SpinChip Hs-cTnI Multisite Precision (HEAT-1)

Multisite Precision Study for the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test

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.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction (AMI)
• Intervention / Treatment: Diagnostic test: SpinChip hs-cTnI

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 Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0275
    • SpinChip Diagnostics
  • Akershus
    • Lørenskog, Akershus, Norway, 1478
      • Akershus University hospital, Akershus Clinical Research Center (ACR)
    • Sandvika, Akershus, Norway, 1346
      • Vestre Viken Bærum Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Precision of the recommended commercially available control material	Calculation of repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test using cTnI results obtained from analysis of commercial control material	1 day
Incidence of AEs, ADEs and DDs	Evaluate safety of the SpinChip Platform, as measured by adverse events (AEs), adverse device effects (ADEs) and device deficiencies (DDs).	1 day

Collaborators and Investigators

• Sponsor: SpinChip Diagnostics ASA
• Collaborators: Scandinavian Contract Research Organization
• Investigators: Principal Investigator: Hlge Røsjø, MD/Professor, Akershus University Hospital, Akershus Clinical Research Center (ACR), Norway

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Actual): March 28, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Diagnostic accuracy; Troponin I; Point of care; Heart attack; High-sensitive; Near-patient test
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Myocardial Infarction; Infarction
• Other Study ID Numbers: Design Protocol-03821; CIV-NO-24-09-049195 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No