SpinChip Hs-cTnI Sample Type Validation

NCT06453707 | Completed

• 2 other identifiers: Design Protocol-03645CIV-NO-24-01-045754
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial Infarction; High-sensitive; Point of Care; Troponin I; Near-patient test; Heart attack

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of AEs, ADEs and DDs

  1 day

Interventions

SpinChip hs-cTnI DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• SpinChip Diagnostics ASA: lead
• Aurevia: collaborator
• University Hospital, Akershus: collaborator

Study Sites (1)

Akershus University hospital, Akershus Clinical Research Center (ACR)

Lørenskog, Akershus, 1474, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Li-heparin plasma

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Helge Røsjø, MD/Professor

  Akershus University Hospital, Akershus Clinical Research Center (ACR)

  PRINCIPAL INVESTIGATOR

• Gro Leite Størvold, PhD

  SpinChip Diagnostics ASA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 12, 2024
• Study Start: April 12, 2024
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)