Myocardial Infarction, AcuteBIOMACNCT04167904
Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction
An observational study of Myocardial Infarction, Acute, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The concentration of troponins in plasma is used for diagnosing acute myocardial infarction. Different types of heart-specific troponins can be measured and with different analytical methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute
- How many people
- 4,446 participants
- Where
- 1 siteNorway
- Study dates
- 10 Dec 2019to 1 Apr 2023
- 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: Patients admitted to St. Olavs Hospital (Trondheim University Hospital) with suspected acute myocardial infarction without ST-elevations on ECG (NSTEMI).
Who may be able to join
- hospitalized at St. Olavs hospital
- blood sampled for troponin analysis due to suspicion of acute myocardial infarction without ST-elevations on ECG less than 4 hours after admitted to the hospital
Who cannot join
- residency outside Norway
- does not understand Norwegian
Trial locations and contacts
1 site in 1 country.
About this study
The concentration of troponins in plasma is used for diagnosing acute myocardial infarction. Different types of heart-specific troponins can be measured and with different analytical methods. The primary aim of this study is to evaluate the diagnostic characteristics of a new analytical method for measuring troponin I in diagnosing acute myocardial infarction.
- Conditions
- Myocardial Infarction, Acute
- Keywords
- Troponin I, Myocardial Infarction, Sensitivity and Specificity, Receiver operation characteristics curve, Biomarkers
- Medical subject headings
- Myocardial Infarction, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute myocardial infarction according to the 4th universal definition of myocardial infarction
Metric: Yes/No
Measured: Before discharge from hospital, a median of 2 days
Secondary outcomes (3)
Days between hospital discharge and death
Metric: Days. The secondary outcome measures will be combined into a composite endpoint reflecting the time between hospital admission and the first secondary outcome measure
Measured: Within 30 days after hospital discharge
Days between hospital discharge and acute myocardial infarction according to the 4th universal definition of myocardial infarction
Metric: Days.
Measured: Within 30 days after hospital discharge
Days between hospital discharge and coronary revascularization
Metric: Days
Measured: Within 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start10 Dec 2019
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,446 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Gustav Mikkelsen, MD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167904
- Sponsor's protocol ID
- 2018/648
- Acronym
- BIOMAC
- Status last verified
- Jun 2025
- First submitted
- 3 Sep 2018
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04167904
- Acronym / sponsor ID
- BIOMAC / 2018/648
- Conditions
- Myocardial Infarction, Acute
- Keywords
- Troponin I, Myocardial Infarction, Sensitivity and Specificity, Receiver operation characteristics curve, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,446 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 19 Nov 2019 (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.
The concentration of troponins in plasma is used for diagnosing acute myocardial infarction. Different types of heart-specific troponins can be measured and with different analytical methods. The primary aim of this study is to evaluate the diagnostic characteristics of a new analytical method for measuring troponin I in diagnosing acute myocardial infarction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to St. Olavs Hospital (Trondheim University Hospital) with suspected acute myocardial infarction without ST-elevations on ECG (NSTEMI).
Key inclusion criteria (2 listed)
- hospitalized at St. Olavs hospital
- blood sampled for troponin analysis due to suspicion of acute myocardial infarction without ST-elevations on ECG less than 4 hours after admitted to the hospital
Key exclusion criteria (2 listed)
- residency outside Norway
- does not understand Norwegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute myocardial infarction according to the 4th universal definition of myocardial infarction
Time frame: Before discharge from hospital, a median of 2 days
Metric: Yes/No
3 secondary outcomes
Days between hospital discharge and death
Time frame: Within 30 days after hospital discharge
Days between hospital discharge and acute myocardial infarction according to the 4th universal definition of myocardial infarction
Time frame: Within 30 days after hospital discharge
Days between hospital discharge and coronary revascularization
Time frame: Within 30 days after hospital discharge
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 8 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Gustav Mikkelsen, MD principal investigator
St. Olavs Hospital
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 Myocardial Infarction, Acute, run by St. Olavs Hospital 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 2 inclusion and 2 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 8 Jun 2025. 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?
Acute myocardial infarction according to the 4th universal definition of myocardial infarction (time frame: Before discharge from hospital, a median of 2 days). 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 8 Jun 2025.