NCT06453707

SpinChip Hs-cTnI Sample Type Validation

Sample Type Validation: Finger Prick and Plasma vs Whole Blood in a Clinical Setting for the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (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 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.

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. The purpose of this study is to demonstrate that different sample types (finger prick, venous whole blood or plasma) give comparable results when analysed using the SpinChip hs-cTnI test when the testing is performed by healthcare professionals. Samples from minimum 150 patients with troponin levels covering the measuring range of the SpinChip hs-cTnI test will be collected and analysed.

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: 2024-04-12
• Primary completion: 2024-07-03
• Completion: 2024-07-03
• First posted: 2024-06-12
• Last updated: 2024-08-22

Locations

1 site across 1 country: Norway