Clinical trial NCT06463275: SpinChip Hs-cTnI Determination of the 99th Percentile URL
Official title: Determination of the 99th Percentile Upper Reference Limits (URLs) for the SpinChip High Sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
High-sensitive
Point of Care
Troponin I
Near-patient test
Heart attack
99th percentile upper reference limit
Lead sponsor: SpinChip Diagnostics ASA
Sponsor class: INDUSTRY
Collaborators: name: Aurevia
name: CTC Clinical Trial Consultants AB
First posted: 2024-06-17
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A minimum of 800 healthy subjects with a balanced gender distribution (minimum 400 females and 400 males).

Brief summary: 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.

Detailed description: 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).

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

Primary outcomes:
measure: Overall 99th percentile URL
timeFrame: 1 day
Secondary outcomes:
measure: Sex-specific 99th percentile URLs
timeFrame: 1 day
measure: Percentage of measurable values above LoD
timeFrame: 1 day
measure: Incidence of AEs, ADEs, and DDs
timeFrame: 1 day
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Phase I-IV Research Unit Karolinska
city: Uppsala
country: Sweden
facility: CTC Clinical Trial Consultants AB
Study officials:
affiliation: CTC Clinical Trial Consultants AB
name: Johan Nilsson, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: