SpinChip Hs-cTnI Sample Type Validation (HEAT-2)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Diagnostic test: SpinChip hs-cTnI

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.

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Norway
  • Akershus
    • Lørenskog, Akershus, Norway, 1474
      • Akershus University hospital, Akershus Clinical Research Center (ACR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Minimum 150 hospitalized patients identified based on cardiac troponin levels obtained from clinical records at Akershus University Hospital.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: SpinChip Diagnostics ASA
• Collaborators: University Hospital, Akershus; Scandinavian Contract Research Organization
• Investigators: Principal Investigator: Helge Røsjø, MD/Professor, Akershus University hospital, Akershus Clinical Research Center (ACR); Study Director: Gro Leite Størvold, PhD, SpinChip Diagnostics ASA

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Actual): July 3, 2024
• Study Completion (Actual): July 3, 2024

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Troponin I; Point of Care; Heart attack; High-sensitive; Near-patient test
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: Design Protocol-03645; CIV-NO-24-01-045754 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No