SpinChip Hs-cTnI Clinical Diagnostic Performance

NCT06499519 | Completed

• 2 other identifiers: Design Protocol-02856CIV-23-12-045095
• Study Type: observational
• Target: 1,551
• Locations: 6 countries
• Sites: 9

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

Conditions

Acute Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• AUROC for cTnI concentrations measured at 1, 2 and 3 hours after admission to the ED

  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

  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

  Day of admission

• Occurrence of MI and/or cardiovascular death (CV) within 30 days

  30 days

• Derivation and validation of rule-in/rule-out 0/1h and 0/2h algorithms

  Day of admission

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SpinChip Diagnostics ASA: lead
• Aurevia: collaborator

Study Sites (9)

Aarhus Universitetshospital

Aarhus, DK-8200, Denmark

Location

Universitätsmedizin Göttingen (University Medical Center Göttingen)

Göttingen, 37099, Germany

Location

Akershus University hospital, Akershus Clinical Research Center (ACR)

Lørenskog, Akerhus, 1474, Norway

Location

Haukland University Hospital, Department of Heart Disease

Bergen, Vestland, 5021, Norway

Location

Danderyd University Hospital

Danderyd, 182 88, Sweden

Location

University hospital Basel, Cardiovascular Research Institute of Basel (CRIB)

Basel, Basel, 4056, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SB, United Kingdom

Location

Royal Alexandra Hospital

Paisley, PA2 9PN, United Kingdom

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

• Helge Røsjø, MD/Professor

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

  PRINCIPAL INVESTIGATOR

• Christian Müller, MD/Professor

  Cardiovascular Research Institute Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: July 15, 2024
• Primary Completion: September 8, 2025
• Study Completion: October 30, 2025
• Last Updated: January 26, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); CH (2); GB (2); DE (1); DK (1); NO (2)