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SpinChip Hs-cTnI Determination of the 99th Percentile URL

NCT06463275 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1355

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. Low levels of troponin are also present in the blood stream of healthy individuals and can be detected by high-sensitive troponin tests. 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 determine the upper reference limits (URLs) for the SpinChip hs-cTnI test in a healthy population.

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

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • SpinChip Diagnostics ASA

    lead INDUSTRY

Principal Investigators

  • Johan Nilsson, MD/PhD · CTC Clinical Trial Consultants AB

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2025-07-22
Completion
2025-09-19

Countries

  • Sweden

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 NCT06463275 on ClinicalTrials.gov