NCT06499519

SpinChip Hs-cTnI Clinical Diagnostic Performance

Clinical Diagnostic Performance of the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,551 (actual)
• Sponsor: SpinChip Diagnostics ASA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Acute Myocardial Infarction

Interventions

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

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-09-08
• Completion: 2025-10-30
• First posted: 2024-07-12
• Last updated: 2026-01-26

Locations

9 sites across 6 countries: Denmark, Germany, Norway, Sweden, Switzerland, United Kingdom