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SpinChip Hs-cTnI Clinical Diagnostic Performance

NCT06499519 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1551

Last updated 2026-01-26

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

SpinChip hs-cTnI

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

Sponsors & Collaborators

  • Aurevia

    collaborator INDUSTRY

  • SpinChip Diagnostics ASA

    lead INDUSTRY

Principal Investigators

  • Helge Røsjø, MD/Professor · Akershus University Hospital, Akershus Clinical Research Center (ACR), Norway

  • Christian Müller, MD/Professor · Cardiovascular Research Institute Basel, Switzerland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2025-09-08
Completion
2025-10-30

Countries

  • Denmark
  • Germany
  • Norway
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06499519 on ClinicalTrials.gov