SpinChip Hs-cTnI Sample Type Validation

Acute Myocardial Infarction Clinical Trial

— HEAT-2  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453707
• Other study ID #: Design Protocol-03645
• Secondary ID: CIV-NO-24-01-045
• Status: Recruiting
• Start date: April 12, 2024
• Est. completion date: December 31, 2033

Study information

• Verified date: June 2024
• Source: SpinChip Diagnostics ASA
• Contact: Gro Leite Størvold, PhD
• Phone: +47 95203051
• Email: gls[@]spinchip.no; clinicaltrial[@]spinchip.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2033
• Est. primary completion date: October 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Norway	Akershus University hospital, Akershus Clinical Research Center (ACR)	Lørenskog	Akershus

Sponsors (3)

Lead Sponsor	Collaborator
SpinChip Diagnostics ASA	Scandinavian Contract Research Organization, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sample type validation	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.	1 day
Secondary	Incidence of AEs, ADEs and DDs	Assess the safety of the SpinChip Platform, as measured by adverse events (AEs), adverse device effects (ADEs) and device deficiencies (DDs).	1 day