Acute Myocardial InfarctionHEAT-3NCT06463275
SpinChip Hs-cTnI Determination of the 99th Percentile URL
An observational study of Acute Myocardial Infarction, run by SpinChip Diagnostics ASA at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- SpinChip hs-cTnI
- How many people
- 1,355 participants
- Where
- 4 sitesSweden
- Study dates
- 20 May 2024to 19 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A minimum of 800 healthy subjects with a balanced gender distribution (minimum 400 females and 400 males).
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Clinical Trial Consultants (CTC) Ebbepark
Linköping, 58213
Clinical Trial Consultants (CTC) GoCo
Mölndal, Gothenburg, 431 53
Phase I-IV Research Unit Karolinska
Solna, 171 64
CTC Clinical Trial Consultants AB
Uppsala, Uppsala County, 752 37
About this study
Official title: Determination of the 99th Percentile Upper Reference Limits (URLs) for the SpinChip High Sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
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.
Read the 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).
- Conditions
- Acute Myocardial Infarction
- Being tested
- SpinChip hs-cTnI
- Keywords
- Acute Myocardial Infarction, High-sensitive, Point of Care, Troponin I, Near-patient test, Heart attack, 99th percentile upper reference limit
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpinChip hs-cTnIDiagnostic test
SpinChip Platform, consisting of the SpinChip hs-cTnI test (self-contained cartridge) and SpinChip Analyzer (instrument).
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 1 day
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).
Measured: 1 day
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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start20 May 2024
- Primary completion22 Jul 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,355 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpinChip Diagnostics ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aurevia, CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Johan Nilsson, MD/PhD, Principal investigator, CTC Clinical Trial Consultants AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463275
- Sponsor's protocol ID
- Design Protocol-03542
- Other IDs
- CIV-SE-23-12-045358
- Acronym
- HEAT-3
- Status last verified
- Jan 2026
- First submitted
- 7 Jun 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the 99th Percentile Upper Reference Limits (URLs) for the SpinChip High Sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
- ClinicalTrials.gov ID
- NCT06463275
- Acronym / sponsor ID
- HEAT-3 / Design Protocol-03542
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,355 participants (actual)
- Lead sponsor
- SpinChip Diagnostics ASAIndustry (pharma, biotech, devices)
- Collaborators
- Aurevia, CTC Clinical Trial Consultants AB
- Study start
- 20 May 2024 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of 800 healthy subjects with a balanced gender distribution (minimum 400 females and 400 males).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpinChip hs-cTnISpinChip Platform, consisting of the SpinChip hs-cTnI test (self-contained cartridge) and SpinChip Analyzer (instrument). | Diagnostic test | – |
Primary outcome
Overall 99th percentile URL
Time frame: 1 day
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
3 secondary outcomes
Sex-specific 99th percentile URLs
Time frame: 1 day
Percentage of measurable values above LoD
Time frame: 1 day
Incidence of AEs, ADEs, and DDs
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Nilsson, MD/PhD principal investigator
CTC Clinical Trial Consultants AB
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by SpinChip Diagnostics ASA at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall 99th percentile URL (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.