NCT06463275Completed
SpinChip Hs-cTnI Determination of the 99th Percentile URL
Determination of the 99th Percentile Upper Reference Limits (URLs) for the SpinChip High Sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1355 (actual)
- First submitted
- 7 Jun 2024
- Start date
- 20 May 2024
- Primary completion date
- 22 Jul 2025
- Lead sponsor
- SpinChip Diagnostics ASA
- Diseases
- Coronary artery disease
- NCT number
- NCT06463275
What you commit to
- Study type: Observational
- Participants enrolled: 1355
- From 20 May 2024 to the primary completion date, 22 Jul 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment for hyperlipidaemia (medication reported in questionnaire)
Other illness
- All known cardiovascular or cardiac diseases (evaluated using questionnaire; personal history of acute myocardial infarction (AMI) or other cardiac diseases (angina, stroke, atrial fibrillation, peripheral vascular disease (PVD), deep vein thrombosis (DVT), pulmonary embolism (PE), cardiac valve disease, heart failure)
- Hypertension (as judged by the investigator) or use of medication for hypertension (medication reported in questionnaire)
- Treatment for diabetes, including dietary treatment (reported in questionnaire)
- Major illness or chronic disease that could affect the heart (lung, liver, unstable or nontreated thyroid disease, or autoimmune diseases (evaluated using questionnaire)
- History of cancer within the last 5 years (based on questionnaire) except basal cell carcinoma (in situ)
Other
- Abnormal BMI (body mass index) (\< 18 kg/m2 or \> 35 kg/m2), calculated from data collected during enrolment visit
- Current smokers (reported in questionnaire)
- Recent acute hospitalisation (within last 3 months, reported in questionnaire)
- Pregnancy (reported in questionnaire)
- Already included in the study
Who the study is looking for
- Able and willing to provide signed written informed consent
- 18-80 years old
- Estimated glomerular filtration rate (eGFR) \> 60 mL/min/1.73 m2 for subjects 18-65 years and \> 50 mL/min/1.73 m2 for subjects \> 66 years
- Haemoglobin A1c (HbA1c) \< 6.5% (\< 48 mmol/mol)
- NT-proBNP (N-terminal prohormone of brain natriuretic peptide) \< 125 ng/L or BNP (brain natriuretic peptide) \< 35 ng/L
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Trial Consultants (CTC) Ebbepark Coordinator of this site? Confirm its status | Linköping | Sweden | Unknown status |
| Clinical Trial Consultants (CTC) GoCo Coordinator of this site? Confirm its status | Mölndal | Sweden | Unknown status |
| Phase I-IV Research Unit Karolinska Coordinator of this site? Confirm its status | Solna | Sweden | Unknown status |
| CTC Clinical Trial Consultants AB Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.