Determining the upper limits for a new heart attack test
Determination of the 99th Percentile Upper Reference Limits (URLs) for the SpinChip High Sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
SpinChip Diagnostics ASA · NCT06463275
This study is testing a new quick blood test for heart attacks to see what normal troponin levels are in healthy people aged 18 to 80.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | SpinChip Diagnostics ASA (industry) |
| Locations | 2 sites (Solna and 1 other locations) |
| Trial ID | NCT06463275 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish the upper reference limits (URLs) for the SpinChip high-sensitivity cardiac troponin I (hs-cTnI) test in a healthy population. The SpinChip hs-cTnI test is designed to measure troponin I levels in the bloodstream, which are critical for diagnosing acute myocardial infarction (AMI). By analyzing blood samples close to the patient, results can be obtained within 10 minutes, significantly faster than traditional laboratory methods. The study will involve healthy participants aged 18-80 who meet specific eligibility criteria, ensuring accurate reference values for this new diagnostic tool.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals aged 18-80 with no known cardiovascular diseases.
Not a fit: Patients with existing cardiovascular conditions or those on treatments for hypertension or diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses of heart attacks, improving patient outcomes.
How similar studies have performed: Other studies have successfully established reference limits for similar high-sensitivity troponin tests, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Treatment for hyperlipidaemia (medication reported in questionnaire) * 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) * Abnormal BMI (body mass index) (\< 18 kg/m2 or \> 35 kg/m2), calculated from data collected during enrolment visit * Current smokers (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) * Recent acute hospitalisation (within last 3 months, reported in questionnaire) * Pregnancy (reported in questionnaire) * Already included in the study
Where this trial is running
Solna and 1 other locations
- Phase I-IV Research Unit Karolinska — Solna, Sweden (RECRUITING)
- CTC Clinical Trial Consultants AB — Uppsala, Sweden (RECRUITING)
Study contacts
- Principal investigator: Johan Nilsson, MD/PhD — CTC Clinical Trial Consultants AB
- Study coordinator: Gro Leite Størvold, PhD
- Email: gls@spinchip.no; clinicaltrial@spinchip.no
- Phone: +47 95203051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myocardial Infarction, High-sensitive, Point of Care, Troponin I, Near-patient test, Heart attack, 99th percentile upper reference limit