Acute Myocardial InfarctionHEAT-4NCT06499519
SpinChip Hs-cTnI Clinical Diagnostic Performance
An observational study of Acute Myocardial Infarction, run by SpinChip Diagnostics ASA at 9 sites in 6 countries.
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 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- SpinChip hs-cTnI
- How many people
- 1,551 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 15 Jul 2024to 30 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects presenting to the emergency department with acute chest discomfort or other symptoms suggestive of AMI. This multicentre study will be conducted at up to 10 sites in the EU/EEA, Switzerland and UK.
Who may be able to join
- Able and willing to provide signed written informed consent
- Subjects ≥ 18 years old
- Subjects presenting at the ED with acute chest discomfort including "pain", "pressure", "tightness", "burning", or "stabbing" and/or other symptoms suggestive of AMI such as upper abdominal pain, left shoulder/arm pain, pain in the jaw, or pain between the scapulae.
Who cannot join
- Subjects experiencing shock
- Self-reported pregnancy
- Previously included in the study (e.g., in case of a second presentation)
- Patient incapable of judgement, for example due to severe pain
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Norway2 sites
Haukland University Hospital, Department of Heart Disease
Bergen, Vestland, 5021
Akershus University hospital, Akershus Clinical Research Center (ACR)
Lørenskog, Akerhus, 1474
Switzerland2 sites
University hospital Basel, Cardiovascular Research Institute of Basel (CRIB)
Basel, Basel, 4056
Luzerner Kantonsspital
Lucerne, 6000
United Kingdom2 sites
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SB
Royal Alexandra Hospital
Paisley, PA2 9PN
Germany1 site
Universitätsmedizin Göttingen (University Medical Center Göttingen)
Göttingen, 37099
About this study
Official title: Clinical Diagnostic Performance of 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. 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 evaluate the diagnostic accuracy and safety of the SpinChip hs-cTnI test relative to a clinically validated hs-cTnI method.
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.
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.
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, open clinical performance study for evaluation of the diagnostic accuracy and safety of the SpinChip hs-cTnI test as an aid in the diagnosis of AMI. Subjects presenting with acute chest discomfort or other symptoms suggestive of AMI will be recruited at the emergency departments (EDs).
- 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, Diagnostic accuracy
- 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.
Area under the receiver operating characteristics (AUROC) curve for cTnI concentrations measured at admission to the emergency department (ED)
Calculate and compare the area under the curve (AUC) for both SpinChip hs-cTnI and clinically validated hs-cTnI method using centrally adjudicated diagnosis of AMI
Measured: Day of admission
Secondary outcomes (6)
AUROC for cTnI concentrations measured at 1, 2 and 3 hours after admission to the ED
Calculate and compare the area under the curve (AUC) for both SpinChip hs-cTnI and clinically validated hs-cTnI method using centrally adjudicated diagnosis of AMI for the given timepoints
Measured: Day of admission
Negative predictive value (NPV) at 0, 1, 2, and 3 hours after admission to the ED using the 99th percentile upper reference limit as clinical cut-off
NPV is defined as the proportion of subjects with measured cTnI concentrations below a clinical cut-off value, who are correctly diagnosed as not having MI.
The NPVs of the SpinChip hs-cTnI test will be calculated for 0, 1, 2, and 3 hours timepoints, using the overall and sex-specific 99th percentile upper reference limits as clinical cut-offs.
Measured: Day of admission
Positive predictive value (PPV) at 0, 1, 2, and 3 hours after admission to the ED using the 99th percentile upper reference limit as clinical cut-off
PPV is defined as the proportion of subjects with measured cTnI concentrations above a clinical cut-off value, who are diagnosed with MI.
The PPV of the SpinChip hs-cTnI test will be calculated for cTnI concentrations obtained 0, 1, 2, and 3 hours timepoints, using the overall and sex-specific 99th percentile URL as clinical cut-offs.
Measured: Day of admission
Occurrence of MI and/or cardiovascular death (CV) within 30 days
Prognostic accuracy for risk of MI/CV death for 30 days evaluated using Kaplan-Meier plots
Cox proportional hazard model will be used to evaluate the prognostic performance of the SpinChip hs-cTnI test for outcomes MI and CV death within 30 days.
Measured: 30 days
Derivation and validation of rule-in/rule-out 0/1h and 0/2h algorithms
Rule-in/rule-out algorithms will be calculated in accordance with the European Society of Cardiology (ESC) rapid rule-in/rule-out protocols for cTnI results obtained at admission (0h) and 1 hours, as well as 0 h and 2 hours after admission. The rule-out limit will be derived so that the sensitivity and NPV is > 99%, and rule-in limit so that the diagnostic specificity and PPV is > 70% using 60% of the study population. The derived rule-out and rule-in limits will be validated using a remaining population.
Measured: Day of admission
Incidence of AEs, ADEs and DDs
Assess the safety of the SpinChip Platform, as measured by adverse events (AEs), adverse device effects (ADEs) and device deficiencies (DDs).
Measured: Day of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start15 Jul 2024
- Primary completion8 Sep 2025
- Study completion30 Oct 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
- 1,551 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpinChip Diagnostics ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aurevia
- Responsible party
- Sponsor
- Investigators
- Helge Røsjø, MD/Professor, Principal investigator, Akershus University Hospital, Akershus Clinical Research Center (ACR), NorwayChristian Müller, MD/Professor, Principal investigator, Cardiovascular Research Institute Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499519
- Sponsor's protocol ID
- Design Protocol-02856
- Other IDs
- CIV-23-12-045095
- Acronym
- HEAT-4
- Status last verified
- Jan 2025
- First submitted
- 5 Jul 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
- Clinical Diagnostic Performance of the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
- ClinicalTrials.gov ID
- NCT06499519
- Acronym / sponsor ID
- HEAT-4 / Design Protocol-02856
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, High-sensitive, Point of Care, Troponin I, Near-patient test, Heart attack, Diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,551 participants (actual)
- Lead sponsor
- SpinChip Diagnostics ASAIndustry (pharma, biotech, devices)
- Collaborators
- Aurevia
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 12 Jul 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. 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 evaluate the diagnostic accuracy and safety of the SpinChip hs-cTnI test relative to a clinically validated hs-cTnI method.
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.
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.
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, open clinical performance study for evaluation of the diagnostic accuracy and safety of the SpinChip hs-cTnI test as an aid in the diagnosis of AMI. Subjects presenting with acute chest discomfort or other symptoms suggestive of AMI will be recruited at the emergency departments (EDs).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting to the emergency department with acute chest discomfort or other symptoms suggestive of AMI. This multicentre study will be conducted at up to 10 sites in the EU/EEA, Switzerland and UK.
Key inclusion criteria (3 listed)
- Able and willing to provide signed written informed consent
- Subjects ≥ 18 years old
- Subjects presenting at the ED with acute chest discomfort including "pain", "pressure", "tightness", "burning", or "stabbing" and/or other symptoms suggestive of AMI such as upper abdominal pain, left shoulder/arm pain, pain in the jaw, or pain between the scapulae.
Key exclusion criteria (4 listed)
- Subjects experiencing shock
- Self-reported pregnancy
- Previously included in the study (e.g., in case of a second presentation)
- Patient incapable of judgement, for example due to severe pain
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
Area under the receiver operating characteristics (AUROC) curve for cTnI concentrations measured at admission to the emergency department (ED)
Time frame: Day of admission
Calculate and compare the area under the curve (AUC) for both SpinChip hs-cTnI and clinically validated hs-cTnI method using centrally adjudicated diagnosis of AMI
6 secondary outcomes
AUROC for cTnI concentrations measured at 1, 2 and 3 hours after admission to the ED
Time frame: Day of admission
Negative predictive value (NPV) at 0, 1, 2, and 3 hours after admission to the ED using the 99th percentile upper reference limit as clinical cut-off
Time frame: Day of admission
Positive predictive value (PPV) at 0, 1, 2, and 3 hours after admission to the ED using the 99th percentile upper reference limit as clinical cut-off
Time frame: Day of admission
Occurrence of MI and/or cardiovascular death (CV) within 30 days
Time frame: 30 days
Derivation and validation of rule-in/rule-out 0/1h and 0/2h algorithms
Time frame: Day of admission
Incidence of AEs, ADEs and DDs
Time frame: Day of admission
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
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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.
Helge Røsjø, MD/Professor principal investigator
Akershus University Hospital, Akershus Clinical Research Center (ACR), Norway
Christian Müller, MD/Professor principal investigator
Cardiovascular Research Institute Basel, Switzerland
9 sites in 6 countries: 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 9 sites in 6 countries.
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 3 inclusion and 4 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 9 sites in Norway, Switzerland, United Kingdom, Denmark, Germany and 1 more country. 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?
Area under the receiver operating characteristics (AUROC) curve for cTnI concentrations measured at admission to the emergency department (ED) (time frame: Day of admission). 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.