An observational study in Acute Myocardial Infarction, sponsored by SpinChip Diagnostics ASA. Completed at 4 sites in Sweden. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.
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. Low levels of troponin are also present in the blood stream of healthy individuals and can be detected by high-sensitive troponin tests. 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 determine the upper reference limits (URLs) for the SpinChip hs-cTnI test in a healthy population.
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.
According to the European Society of Cardiology (ESC) 2023 guideline for acute coronary syndrome (ACS) in patients presenting without persistent ST-segment elevation, an elevated cTn value above the 99th percentile upper reference limit (URL) indicates myocardial injury, and when accompanied by evidence of acute myocardial ischemia, the disease is defined as AMI. The diagnostic threshold (99th percentile URL) for each hs-cTn test method must be specifically established.
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 using fresh venous whole blood and plasma samples.
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.
This study is a multicentre, prospective, observational, non-randomised, clinical performance study in healthy subjects to determine the 99th percentile URLs for the SpinChip hs-cTnI test according to recommendations from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 1,355 is above 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.
A minimum of 800 healthy subjects with a balanced gender distribution (minimum 400 females and 400 males).
Exclusion Criteria:
SpinChip Platform, consisting of the SpinChip hs-cTnI test (self-contained cartridge) and SpinChip Analyzer (instrument).
Overall 99th percentile URL
Determine the overall 99th percentile URL of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin whole blood and Li-Heparin plasma samples using the non-parametric method
Time frame: 1 day
Sex-specific 99th percentile URLs
Calculate the sex-specific 99th percentile URLs of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin whole blood and Li-Heparin plasma samples using the non-parametric method.
Time frame: 1 day
Percentage of measurable values above LoD
To assess the sensitivity of the SpinChip hs-cTnI test quantified as the percentage (%) of measurable values (\>limit of detection, LoD) for males, females, and the overall population, for each sample type (Li-Heparin whole blood and Li-Heparin plasma).
Time frame: 1 day
Incidence of AEs, ADEs, and DDs
Assess 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
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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SpinChip Diagnostics ASA