An observational study in Myocardial Infarction (MI) and Acute Coronary Syndromes (ACS), sponsored by Central Denmark Region. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Central Denmark Region · Observational
Among 100 studies in Myocardial Infarction with a site in Denmark — 13 open to participants now, 24 under way, 6 of them phase 3. Myocardial Infarction · Denmark.
Among the 100 studies in Myocardial Infarction with a site in Denmark, this one is the 11th largest by planned enrollment of the 20 observational ones, is one of 5 that started in 2026, is one of 20 observational ones, reaches primary completion later than 10 of the 23 other live ones, and was the 98th registered.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's planned enrollment of 500 is below the median of 568 across 814 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →13 of the 100 studies in Myocardial Infarction with a site in Denmark are open now, in 12 countries. Each count lists the studies.
Of the 255 Myocardial Infarction studies recruiting now, 172 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →100 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 5 started in 2026.
Median enrollment 811 across the 80 interventional studies, 703 across the 20 observational. Of the 64 that completed or were terminated, 16 (25%) have results posted.
35 of 100 have an industry lead sponsor. The 10 most frequent:
Central Denmark Region is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Central Denmark Region has 1 study filed under Myocardial Infarction — fewer than ten, so there is no comparison to draw.
5 of the studies in Myocardial Infarction with a site in Denmark that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06118281Phase 3Novo Nordisk A/SARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack | 2027-01-29 |
| NCT04957719Phase 3Viatris Innovation GmbHSelatogrel Outcome Study in Suspected Acute Myocardial Infarction | 2027-07 |
| NCT03620266Ole Frobert, MD, PhDEffects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI | 2026-12-31 |
| NCT07563998Central Denmark RegionPrehospital Point-of-Care Hs-Troponin I for Rule-Out of Acute Myocardial Infarction in Patients Without ST-Segment Elevation | 2027-05-14 |
| NCT05665608Charite University, Berlin, GermanyPrevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation | 2027-11-30 |
Among the 100 studies in Myocardial Infarction with a site in Denmark, from their registry updates:
People who call emergency medical services (EMS) with chest pain or other possible heart-related symptoms are often taken to hospital for further testing. However, only a small proportion of these patients are ultimately diagnosed with a serious heart condition such as a heart attack. This means that many patients undergo hospital transport and evaluation even though their risk is low.
In hospitals, a blood test called high-sensitivity cardiac troponin is commonly used to help diagnose or rule out heart attacks. It is not yet well established whether this type of test can be used safely and effectively earlier, in the prehospital setting.
This study will investigate whether it is feasible to measure high-sensitivity troponin in the ambulance and how well the test can identify patients at low risk of serious heart conditions. A small blood sample will be taken as part of routine care and analyzed using a portable device. The test result will not be used to guide treatment or decisions during the study.
The study will assess how well the test predicts heart-related events within 30 days and how practical it is to perform the test in real-life emergency settings. The results may help guide future research on how to improve early assessment and decision-making for patients with suspected heart disease.
This is a prospective observational diagnostic accuracy and feasibility study conducted in the Central Denmark Region.
Adult patients assessed by participating emergency medical services (EMS) units with symptoms suggestive of acute coronary syndrome (ACS), without ST-segment elevation on the prehospital electrocardiogram, and managed with planned transport to hospital are eligible for inclusion.
During routine EMS assessment, a venous blood sample (\<0.5 mL) is obtained and analyzed using a portable point-of-care device for measurement of high-sensitivity cardiac troponin I (hs-TnI). The measurement is performed according to manufacturer instructions and local procedures. Troponin values are recorded for research purposes only and are not used to guide clinical decision-making. EMS personnel are not provided with interpretation guidance or clinical thresholds for hs-TnI.
Clinical assessment, treatment, triage, and transport decisions follow standard regional protocols and are independent of study participation.
Clinical data are obtained from prehospital records and hospital electronic health records. Final diagnoses, including acute coronary syndrome, are determined based on standard clinical evaluation, including serial in-hospital troponin measurements and other diagnostic procedures as clinically indicated.
The primary analysis evaluates the diagnostic performance of prehospital hs-TnI for identifying acute coronary syndrome and predicting major adverse cardiac events within 30 days. Diagnostic performance will be reported using sensitivity, specificity, positive and negative predictive values, likelihood ratios, and area under the receiver operating characteristic curve.
Secondary analyses assess associations between hs-TnI concentrations and clinical outcomes, including hospital admission, length of stay, coronary angiography, coronary revascularization, and 30-day mortality.
Feasibility outcomes include the proportion of successful blood sampling, the proportion of valid measurements, and the time from patient contact to availability of the biomarker result.
The study is designed to generate feasibility and diagnostic accuracy data to inform the design and statistical planning of future interventional studies in the prehospital setting.
The study has been assessed by The Central Denmark Region Committees on Health Research Ethics, which determined that the project does not require notification or approval under Danish legislation.
Patients are recruited from the prehospital emergency medical services (EMS) system in the Central Denmark Region, Denmark. Participants are identified during routine ambulance missions by EMS personnel in units equipped with point-of-care testing (POCT) devices and trained in study procedures. The study population reflects real-world prehospital patients encountered in a publicly funded, tax-supported healthcare system with universal access to emergency care. Patients are included consecutively during the study period based on operational availability of participating EMS units.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients assessed by participating emergency medical services (EMS) units with symptoms suggestive of acute coronary syndrome (ACS), in whom ST-segment elevation myocardial infarction (STEMI) is not identified on the prehospital electrocardiogram, and who are managed with planned transport to hospital for further evaluation. Patients undergo prehospital blood sampling for high-sensitivity cardiac troponin I (hs-TnI) measurement using a point-of-care device. Clinical management, triage, and transport decisions are not influenced by study participation or biomarker results.
Diagnostic Test: Prehospital high-sensitivity cardiac troponin I measurement
Prehospital measurement of high-sensitivity cardiac troponin I (hs-TnI) using a point-of-care device during routine emergency medical services (EMS) assessment. Blood samples are analyzed according to manufacturer instructions and local procedures. The test is performed for research purposes only, and results are not available for clinical decision-making and do not influence patient management.
Also known as: hs-TnI, Point-of-care troponin, i-STAT hs-TnI
Major adverse cardiac events (MACE) within 30 days
Composite outcome including acute myocardial infarction, coronary revascularization, or cardiovascular death within 30 days of the index emergency medical services contact.
Time frame: 30 days
Final diagnosis of acute coronary syndrome
Final hospital diagnosis of acute coronary syndrome based on standard clinical evaluation, including serial cardiac troponin measurements and other diagnostic procedures as clinically indicated.
Time frame: 24 hours
All-cause 30-day mortality
Death from any cause within 30 days of the index emergency medical services contact.
Time frame: 30 days
Coronary revascularization within 30 days
Percutaneous coronary intervention or coronary artery bypass grafting performed within 30 days of the index emergency medical services contact.
Time frame: 30 days
Diagnostic performance of prehospital hs-TnI for acute coronary syndrome
Diagnostic performance of prehospital high-sensitivity cardiac troponin I for identifying acute coronary syndrome, reported as sensitivity, specificity, positive and negative predictive values, likelihood ratios, and area under the receiver operating characteristic curve.
Time frame: 24 hours
Diagnostic performance of prehospital hs-TnI for 30-day MACE
Diagnostic performance of prehospital high-sensitivity cardiac troponin I for predicting major adverse cardiac events within 30 days, reported as sensitivity, specificity, positive and negative predictive values, likelihood ratios, and area under the receiver operating characteristic curve.
Time frame: 30 days
Successful prehospital blood sampling
Proportion of eligible patients in whom a prehospital blood sample for high-sensitivity cardiac troponin I measurement is successfully obtained and analyzed.
Time frame: 24 hours
Valid hs-TnI measurement
Proportion of prehospital high-sensitivity cardiac troponin I measurements yielding a valid result without device or cartridge error.
Time frame: 24 hours
Time to hs-TnI result
Time from first EMS patient contact to availability of the prehospital high-sensitivity cardiac troponin I result.
Time frame: 24 hours
Agreement between prehospital and in-hospital hs-TnI measurements
Agreement between prehospital point-of-care high-sensitivity cardiac troponin I (hs-TnI) measurements and in-hospital hs-TnI measurements performed on the same blood sample. This analysis is conducted in a subset of patients admitted directly to the Department of Cardiology, where blood samples obtained prehospitally are handed over at hospital admission for laboratory analysis. Agreement will be assessed using appropriate statistical methods (e.g., correlation and agreement analyses).
Time frame: 24 hours
Exploratory risk stratification based on prehospital hs-TnI concentrations and symptom onset timing
Exploratory classification of patients according to prehospital high-sensitivity cardiac troponin I (hs-TnI) concentrations in relation to time from symptom onset. Patients will be categorized into groups with: (1) low hs-TnI concentrations associated with low risk of acute coronary syndrome and major adverse cardiac events; (2) intermediate or moderately elevated hs-TnI concentrations representing a potential observation group, including patients with elevated hs-TnI concentrations who remain at low risk of acute coronary syndrome and major adverse cardiac events; and (3) higher hs-TnI concentrations associated with increased risk of acute coronary syndrome and major adverse cardiac events. Analyses will explore the potential for serial prehospital hs-TnI measurements and the identification of patient groups with differing risk profiles. These analyses are descriptive and exploratory and are not used to guide clinical decision-making.
Time frame: 30 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be made publicly available due to Danish data protection legislation (GDPR) and regional regulations governing the use of health data. The study relies on linked prehospital and hospital registry data obtained under specific approvals, which do not permit sharing of individual-level data outside the secure research environment. Data access is restricted to authorized personnel. Aggregated and anonymized results may be shared upon reasonable request and subject to relevant approvals.
Started Jul 2026 (actual). Primary completion is estimated for May 2027, 10 months after the start.
Of 296 non-industry observational studies under Myocardial Infarction, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 140. This study's planned 10 months is below that.
Counting every sponsor, half of 333 studies reached it within 48 months; a quarter within 17 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
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Central Denmark Region