SpinChip Hs-cTnI Determination of the 99th Percentile URL

Launched by SPINCHIP DIAGNOSTICS ASA · Jun 12, 2024

Keywords

ClinConnect Summary

This clinical trial, called the SpinChip Hs-cTnI Determination of the 99th Percentile URL, is studying a new test that measures a protein called cardiac troponin I in the blood. This protein is released during a heart attack, and doctors use its levels to help diagnose if someone is having a heart attack. The goal of this study is to find out what the normal or healthy levels of this protein should be when using the new SpinChip test.

To participate in this study, you need to be between 18 and 80 years old and generally healthy, meaning you shouldn't have any known heart diseases or conditions that could affect your heart health. If you qualify, you will provide written consent and undergo some simple health assessments. This study is currently looking for participants, and your involvement could help improve heart attack diagnosis for everyone in the future.

Gender

ALL

Eligibility 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