Acute Myocardial InfarctionHEAT-2NCT06453707
SpinChip Hs-cTnI Sample Type Validation
An observational study of Acute Myocardial Infarction, run by SpinChip Diagnostics ASA at 1 site 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
- What is being tested?
- SpinChip hs-cTnI
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- 12 Apr 2024to 3 Jul 2024
- 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: Minimum 150 hospitalized patients identified based on cardiac troponin levels obtained from clinical records at Akershus University Hospital.
Who may be able to join
- Able and willing to provide signed written informed consent
- Subjects >18 years old
- Clinical cardiac Troponin T concentration available
Who cannot join
- Cognitive impairment precluding informed consent
- Self-reported pregnancy
- General clinical condition which 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 measuring range of the SpinChip hs-cTnI test
Trial locations and contacts
1 site in 1 country.
Norway1 site
Akershus University hospital, Akershus Clinical Research Center (ACR)
Lørenskog, Akershus, 1474
About this study
Official title: Sample Type Validation: Finger Prick and Plasma vs Whole Blood in a Clinical Setting 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 demonstrate that different types of blood samples (finger prick, venous whole blood and plasma) return comparable results when analysed using the SpinChip hs-cTnI test. Blood samples from at least 150 patients will be analyzed and the testing will be carried out by healthcare personnel.
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.
The purpose of this study is to demonstrate that different sample types (finger prick, venous whole blood or plasma) give comparable results when analysed using the SpinChip hs-cTnI test when the testing is performed by healthcare professionals. Samples from minimum 150 patients with troponin levels covering the measuring range of the SpinChip hs-cTnI test will be collected and analysed.
- 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
- 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.
Sample type validation
Establish if the hs-cTnI results obtained from finger prick capillary blood and fresh plasma are equivalent to results obtained for venous whole blood for the SpinChip hs-cTnI test when the analysis is performed by healthcare professionals. Equivalence between sample types will be evaluated using Bland Altman difference plots for evaluation of bias and regression analysis.
Measured: 1 day
Secondary outcomes (1)
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: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start12 Apr 2024
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpinChip Diagnostics ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aurevia, University Hospital, Akershus
- Responsible party
- Sponsor
- Investigators
- Helge Røsjø, MD/Professor, Principal investigator, Akershus University Hospital, Akershus Clinical Research Center (ACR)Gro Leite Størvold, PhD, Study director, SpinChip Diagnostics ASA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453707
- Sponsor's protocol ID
- Design Protocol-03645
- Other IDs
- CIV-NO-24-01-045754
- Acronym
- HEAT-2
- Status last verified
- Aug 2024
- First submitted
- 29 May 2024
- Last updated
- 22 Aug 2024
- 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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sample Type Validation: Finger Prick and Plasma vs Whole Blood in a Clinical Setting for the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
- ClinicalTrials.gov ID
- NCT06453707
- Acronym / sponsor ID
- HEAT-2 / Design Protocol-03645
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, High-sensitive, Point of Care, Troponin I, Near-patient test, Heart attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- SpinChip Diagnostics ASAIndustry (pharma, biotech, devices)
- Collaborators
- Aurevia, University Hospital, Akershus
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 12 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. 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 demonstrate that different types of blood samples (finger prick, venous whole blood and plasma) return comparable results when analysed using the SpinChip hs-cTnI test. Blood samples from at least 150 patients will be analyzed and the testing will be carried out by healthcare personnel.
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.
The purpose of this study is to demonstrate that different sample types (finger prick, venous whole blood or plasma) give comparable results when analysed using the SpinChip hs-cTnI test when the testing is performed by healthcare professionals. Samples from minimum 150 patients with troponin levels covering the measuring range of the SpinChip hs-cTnI test will be collected and analysed.
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
- Minimum 150 hospitalized patients identified based on cardiac troponin levels obtained from clinical records at Akershus University Hospital.
Key inclusion criteria (3 listed)
- Able and willing to provide signed written informed consent
- Subjects >18 years old
- Clinical cardiac Troponin T concentration available
Key exclusion criteria (4 listed)
- Cognitive impairment precluding informed consent
- Self-reported pregnancy
- General clinical condition which 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 measuring range of the SpinChip hs-cTnI test
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
Sample type validation
Time frame: 1 day
Establish if the hs-cTnI results obtained from finger prick capillary blood and fresh plasma are equivalent to results obtained for venous whole blood for the SpinChip hs-cTnI test when the analysis is performed by healthcare professionals. Equivalence between sample types will be evaluated using Bland Altman difference plots for evaluation of bias and regression analysis.
1 secondary outcome
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 22 Aug 2024.
- 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)
Gro Leite Størvold, PhD study director
SpinChip Diagnostics ASA
1 site 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 1 site 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 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Sample type validation (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 22 Aug 2024.