An observational study in Acute Myocardial Infarction, sponsored by SpinChip Diagnostics ASA. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by SpinChip Diagnostics ASA · Observational
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.
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 180 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →SpinChip Diagnostics ASA is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Minimum 150 hospitalized patients identified based on cardiac troponin levels obtained from clinical records at Akershus University Hospital.
Exclusion Criteria:
SpinChip Platform, consisting of the SpinChip hs-cTnI test (self-contained cartridge) and SpinChip Analyzer (instrument)
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.
Time frame: 1 day
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).
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
SpinChip Diagnostics ASA