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SpinChip Hs-cTnI Sample Type Validation

NCT06453707 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2024-08-22

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 demonstrate that different types of blood samples (finger prick, venous whole blood and plasma) return comparable results when analysed using the SpinChip hs-cTnI test. Blood samples from at least 150 patients will be analyzed and the testing will be carried out by healthcare personnel.

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

  • University Hospital, Akershus

    collaborator OTHER

  • SpinChip Diagnostics ASA

    lead INDUSTRY

Principal Investigators

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

  • Gro Leite Størvold, PhD · SpinChip Diagnostics ASA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-12
Primary Completion
2024-07-03
Completion
2024-07-03

Countries

  • Norway

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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 NCT06453707 on ClinicalTrials.gov