SpinChip Hs-cTnI Clinical Diagnostic Performance (HEAT-4)

Clinical Diagnostic Performance of 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 evaluate the diagnostic accuracy and safety of the SpinChip hs-cTnI test relative to a clinically validated hs-cTnI method.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction
• 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 study is a multicentre, prospective, observational, non-randomised, open clinical performance study for evaluation of the diagnostic accuracy and safety of the SpinChip hs-cTnI test as an aid in the diagnosis of AMI. Subjects presenting with acute chest discomfort or other symptoms suggestive of AMI will be recruited at the emergency departments (EDs).

• Study Type: Observational
• Enrollment (Actual): 1551

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, DK-8200
    • Aarhus Universitetshospital
• Germany
  • Göttingen, Germany, 37099
    • Universitätsmedizin Göttingen (University Medical Center Göttingen)
• Norway
  • Akerhus
    • Lørenskog, Akerhus, Norway, 1474
      • Akershus University hospital, Akershus Clinical Research Center (ACR)
  • Vestland
    • Bergen, Vestland, Norway, 5021
      • Haukland University Hospital, Department of Heart Disease
• Sweden
  • Danderyd, Sweden, 182 88
    • Danderyd University Hospital
• Switzerland
  • Lucerne, Switzerland, 6000
    • Luzerner Kantonsspital
  • Basel
    • Basel, Basel, Switzerland, 4056
      • University hospital Basel, Cardiovascular Research Institute of Basel (CRIB)
• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SB
    • Royal Infirmary of Edinburgh
  • Paisley, United Kingdom, PA2 9PN
    • Royal Alexandra Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting to the emergency department with acute chest discomfort or other symptoms suggestive of AMI. This multicentre study will be conducted at up to 10 sites in the EU/EEA, Switzerland and UK.

Description

Inclusion Criteria:

• Able and willing to provide signed written informed consent
• Subjects ≥ 18 years old
• Subjects presenting at the ED with acute chest discomfort including "pain", "pressure", "tightness", "burning", or "stabbing" and/or other symptoms suggestive of AMI such as upper abdominal pain, left shoulder/arm pain, pain in the jaw, or pain between the scapulae.

Exclusion Criteria:

• Subjects experiencing shock
• Self-reported pregnancy
• Previously included in the study (e.g., in case of a second presentation)
• Patient incapable of judgement, for example due to severe pain

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the receiver operating characteristics (AUROC) curve for cTnI concentrations measured at admission to the emergency department (ED)	Calculate and compare the area under the curve (AUC) for both SpinChip hs-cTnI and clinically validated hs-cTnI method using centrally adjudicated diagnosis of AMI	Day of admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUROC for cTnI concentrations measured at 1, 2 and 3 hours after admission to the ED	Calculate and compare the area under the curve (AUC) for both SpinChip hs-cTnI and clinically validated hs-cTnI method using centrally adjudicated diagnosis of AMI for the given timepoints	Day of admission
Negative predictive value (NPV) at 0, 1, 2, and 3 hours after admission to the ED using the 99th percentile upper reference limit as clinical cut-off	NPV is defined as the proportion of subjects with measured cTnI concentrations below a clinical cut-off value, who are correctly diagnosed as not having MI. The NPVs of the SpinChip hs-cTnI test will be calculated for 0, 1, 2, and 3 hours timepoints, using the overall and sex-specific 99th percentile upper reference limits as clinical cut-offs.	Day of admission
Positive predictive value (PPV) at 0, 1, 2, and 3 hours after admission to the ED using the 99th percentile upper reference limit as clinical cut-off	PPV is defined as the proportion of subjects with measured cTnI concentrations above a clinical cut-off value, who are diagnosed with MI. The PPV of the SpinChip hs-cTnI test will be calculated for cTnI concentrations obtained 0, 1, 2, and 3 hours timepoints, using the overall and sex-specific 99th percentile URL as clinical cut-offs.	Day of admission
Occurrence of MI and/or cardiovascular death (CV) within 30 days	Prognostic accuracy for risk of MI/CV death for 30 days evaluated using Kaplan-Meier plots Cox proportional hazard model will be used to evaluate the prognostic performance of the SpinChip hs-cTnI test for outcomes MI and CV death within 30 days.	30 days
Derivation and validation of rule-in/rule-out 0/1h and 0/2h algorithms	Rule-in/rule-out algorithms will be calculated in accordance with the European Society of Cardiology (ESC) rapid rule-in/rule-out protocols for cTnI results obtained at admission (0h) and 1 hours, as well as 0 h and 2 hours after admission. The rule-out limit will be derived so that the sensitivity and NPV is > 99%, and rule-in limit so that the diagnostic specificity and PPV is > 70% using 60% of the study population. The derived rule-out and rule-in limits will be validated using a remaining population.	Day of admission
Incidence of AEs, ADEs and DDs	Assess the safety of the SpinChip Platform, as measured by adverse events (AEs), adverse device effects (ADEs) and device deficiencies (DDs).	Day of admission

Collaborators and Investigators

• Sponsor: SpinChip Diagnostics ASA
• Collaborators: Aurevia
• Investigators: Principal Investigator: Helge Røsjø, MD/Professor, Akershus University Hospital, Akershus Clinical Research Center (ACR), Norway; Principal Investigator: Christian Müller, MD/Professor, Cardiovascular Research Institute Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): September 8, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 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; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction
• Other Study ID Numbers: Design Protocol-02856; CIV-23-12-045095 (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