Acute Myocardial Infarction (AMI)HEAT-1NCT06851013
SpinChip Hs-cTnI Multisite Precision
An observational study of Acute Myocardial Infarction (AMI), run by SpinChip Diagnostics ASA at 3 sites in Norway.
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 (AMI)
- What is being tested?
- SpinChip hs-cTnI
- How many people
- 37 participants
- Where
- 3 sitesNorway
- Study dates
- 3 Feb 2025to 28 Mar 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: Hospitalized, adult subjects with known cTn values obtained from medical records. The study population will be recruited from two clinical sites in Norway.
Who may be able to join
- Able and willing to provide signed written informed consent
- Subjects >18 years old
- Clinical cTn concentrations available
Who cannot join
- Cognitive impairment precluding informed consent
- Self-reported pregnancy
- General clinical condition that affects the patient in a major way and the patient is considered to be in an unstable clinical condition
- Previously included in the study with a sample within the required concentration ranges for the SpinChip hs-cTnI test
- No venous blood sample collected for the study
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Akershus University Hospital, Akershus Clinical Research Center (ACR)
Lørenskog, Akershus, 1478
SpinChip Diagnostics
Oslo, Oslo, 0275
Vestre Viken Bærum Hospital
Sandvika, Akershus, 1346
About this study
Official title: Multisite Precision Study 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. 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 establish the precision of the SpinChip hs-cTnI test when using Li-Heparin plasma and whole blood samples in the hands of the intended user in the intended use setting at multiple sites.
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 multisite prospective, observational, non-randomized validation study will establish the repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test for Li-Heparin plasma and repeatability for Li-Heparin whole blood samples. Potential subjects will be identified based on clinical cardiac troponin levels obtained from medical records at the individual study site.
- Conditions
- Acute Myocardial Infarction (AMI)
- 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.
Precision of the SpinChip hs-cTnI test using Li-heparin plasma and whole blood samples
Calculation of repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin plasma. Calculation of repeatability of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin whole blood.
Measured: 1 day
Secondary outcomes (2)
Precision of the recommended commercially available control material
Calculation of repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test using cTnI results obtained from analysis of commercial control material
Measured: 1 day
Incidence of AEs, ADEs and DDs
Evaluate 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 posted28 Feb 2025
- Study start3 Feb 2025
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpinChip Diagnostics ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aurevia
- Responsible party
- Sponsor
- Investigators
- Hlge Røsjø, MD/Professor, Principal investigator, Akershus University Hospital, Akershus Clinical Research Center (ACR), Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851013
- Sponsor's protocol ID
- Design Protocol-03821
- Other IDs
- CIV-NO-24-09-049195
- Acronym
- HEAT-1
- Status last verified
- May 2025
- First submitted
- 19 Feb 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Precision Study for the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
- ClinicalTrials.gov ID
- NCT06851013
- Acronym / sponsor ID
- HEAT-1 / Design Protocol-03821
- Conditions
- Acute Myocardial Infarction (AMI)
- 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
- 37 participants (actual)
- Lead sponsor
- SpinChip Diagnostics ASAIndustry (pharma, biotech, devices)
- Collaborators
- Aurevia
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 28 Feb 2025 (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 establish the precision of the SpinChip hs-cTnI test when using Li-Heparin plasma and whole blood samples in the hands of the intended user in the intended use setting at multiple sites.
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 multisite prospective, observational, non-randomized validation study will establish the repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test for Li-Heparin plasma and repeatability for Li-Heparin whole blood samples. Potential subjects will be identified based on clinical cardiac troponin levels obtained from medical records at the individual study site.
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
- Hospitalized, adult subjects with known cTn values obtained from medical records. The study population will be recruited from two clinical sites in Norway.
Key inclusion criteria (3 listed)
- Able and willing to provide signed written informed consent
- Subjects >18 years old
- Clinical cTn concentrations available
Key exclusion criteria (5 listed)
- Cognitive impairment precluding informed consent
- Self-reported pregnancy
- General clinical condition that affects the patient in a major way and the patient is considered to be in an unstable clinical condition
- Previously included in the study with a sample within the required concentration ranges for the SpinChip hs-cTnI test
- No venous blood sample collected for the study
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
Precision of the SpinChip hs-cTnI test using Li-heparin plasma and whole blood samples
Time frame: 1 day
Calculation of repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin plasma. Calculation of repeatability of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin whole blood.
2 secondary outcomes
Precision of the recommended commercially available control material
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 14 May 2025.
- 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.
Hlge Røsjø, MD/Professor principal investigator
Akershus University Hospital, Akershus Clinical Research Center (ACR), Norway
3 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 (AMI), run by SpinChip Diagnostics ASA at 3 sites in Norway.
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 5 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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?
Precision of the SpinChip hs-cTnI test using Li-heparin plasma and whole blood samples (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 14 May 2025.