Skip to main content
OpenTrials
Completed

NCT Number: NCT06453707

SpinChip Hs-cTnI Sample Type Validation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University hospital, Akershus Clinical Research Center (ACR)

Lørenskog, Akershus, 1474, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to provide signed written informed consent
  • Subjects >18 years old
  • Clinical cardiac Troponin T concentration available

Exclusion criteria

  • Cognitive impairment precluding informed consent
  • Self-reported pregnancy
  • General clinical condition which affects the patient in a major way and the patient is considered to be in an unstable clinical condition
  • Previously included in the study with a sample within the measuring range of the SpinChip hs-cTnI test

Treatment and study plan

SpinChip hs-cTnI

Diagnostic Test

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

Primary outcomes

  1. Sample type validation

    Time frame: 1 day

    Establish if the hs-cTnI results obtained from finger prick capillary blood and fresh plasma are equivalent to results obtained for venous whole blood for the SpinChip hs-cTnI test when the analysis is performed by healthcare professionals. Equivalence between sample types will be evaluated using Bland Altman difference plots for evaluation of bias and regression analysis.

Secondary outcomes

  1. Incidence of AEs, ADEs and DDs

    Time frame: 1 day

    Assess the safety of the SpinChip Platform, as measured by adverse events (AEs), adverse device effects (ADEs) and device deficiencies (DDs).

Sponsors and collaborators

Lead sponsor

SpinChip Diagnostics ASA

Industry

Collaborators

  • Aurevia
  • University Hospital, Akershus

Registry information

Official study title

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

Acronym: HEAT-2

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 12, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.