SpinChip Hs-cTnI Determination of the 99th Percentile URL

Acute Myocardial Infarction Clinical Trial

— HEAT-3  

Official title:

Determination of the 99th Percentile Upper Reference Limits (URLs) for the SpinChip High Sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06463275
• Other study ID #: Design Protocol-03542
• Secondary ID: CIV-SE-23-12-045
• Status: Recruiting
• Start date: May 20, 2024
• Est. completion date: January 20, 2025

Study information

• Verified date: June 2024
• Source: SpinChip Diagnostics ASA
• Contact: Gro Leite Størvold, PhD
• Phone: +47 95203051
• Email: gls[@]spinchip.no; clinicaltrial[@]spinchip.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: January 20, 2025
• Est. primary completion date: January 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• SpinChip hs-cTnI
SpinChip Platform, consisting of the SpinChip hs-cTnI test (self-contained cartridge) and SpinChip Analyzer (instrument).

Locations

Country	Name	City	State
Sweden	Phase I-IV Research Unit Karolinska	Solna
Sweden	CTC Clinical Trial Consultants AB	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
SpinChip Diagnostics ASA	CTC Clinical Trial Consultants AB, Scandinavian Contract Research Organization

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day
Secondary	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.	1 day
Secondary	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).	1 day
Secondary	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).	1 day