Coronary Syndrome, AcuteDanRUSHNCT07727135
Rapid or Ultra-rapid Diagnosis of Myocardial Infarction Using High-Sensitivity Cardiac Troponin on Hospital Presentation
A study testing 0/3-hour high-sensitivity cardiac troponin algorithm and 0/1-hour high-sensitivity cardiac troponin algorithm in people with Coronary Syndrome, Acute and Myocardial Infarction, run by Herlev and Gentofte Hospital at 11 sites in Denmark.
Trial summary
People with chest pain are often tested for a heart attack using a blood test called high-sensitivity cardiac troponin (hs-cTn). Traditionally, this blood test is repeated 3 hours after the first sample. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Syndrome, Acute, Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- 0/3-hour high-sensitivity cardiac troponin algorithm and 0/1-hour high-sensitivity cardiac troponin algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28,000 participants
- Where
- 11 sitesDenmark
- Study dates
- 1 Sep 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adults (≥18 years) presenting with suspected acute coronary syndrome (ACS) with a clinical indication for high-sensitivity cardiac troponin testing
Who cannot join
- Age <18 years.
- ST-segment elevation myocardial infarction (STEMI) identified on the presenting electrocardiogram and requiring immediate reperfusion therapy.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Denmark11 sites
Aalborg University Hospital
Aalborg, 9000
Bispebjerg & Frederiksberg Hospital
Bispebjerg, 2400
Esbjerg og Grindsted Sygehus
Esbjerg, 6700
Gødstrup Regional Hospital
Gødstrup, 7400
Herlev & Gentofte Hospital
Herlev, 2730
Nordsjællands Hospital
Hillerød, 3400
Amager & Hvidovre Hospital
Hvidovre, 2650
Nykøbing Falster County Hospital
Nykøbing Falster, 4800
Odense University Hospital
Odense, 5000
Svendborg Hospital
Svendborg, 5700
Central Jutland Regional Hospital (Viborg Hospital & Silkeborg Hospital)
Viborg, 8800
About this study
Official title: Danish Randomized Trial of Rapid or Ultra-rapid Diagnosis of Myocardial Infarction Using High-Sensitivity Cardiac Troponin on Hospital Presentation
People with chest pain are often tested for a heart attack using a blood test called high-sensitivity cardiac troponin (hs-cTn). Traditionally, this blood test is repeated 3 hours after the first sample. Newer guidelines recommend repeating the test after 1 hour instead, which may allow patients to receive a diagnosis and leave the hospital sooner.
The purpose of the DanRUSH trial is to compare these two strategies: repeating the blood test after 1 hour versus after 3 hours in adults with suspected acute coronary syndrome. The study will evaluate whether the 1-hour strategy is as safe as the 3-hour strategy while reducing the length of hospital stay.
DanRUSH is a nationwide, pragmatic, cluster-randomized trial conducted in emergency- and cardiology departments across Denmark. The results will help determine the best timing for blood testing in patients with suspected heart attack and improve future care for these patients.
Read the detailed description
Each year, approximately 80,000 individuals present to the Danish healthcare system with chest pain. Of these, around 25,000 are admitted to hospital and approximately 8,000 are diagnosed with acute myocardial infarction. High-sensitivity cardiac troponin (hs-cTn) is the cornerstone biomarker for the diagnosis of myocardial infarction and is essential for the rapid rule-in and rule-out of acute coronary syndromes. Because the diagnosis of myocardial infarction relies not only on troponin concentration but also on changes in troponin levels over time, serial blood sampling is required to distinguish acute myocardial injury from chronic elevations.
Advances in hs-cTn assay sensitivity have enabled progressively shorter intervals between serial blood sampling. Traditionally, most emergency departments have used a 0/3-hour algorithm, in which hs-cTn is measured at presentation and again after 3 hours. However, contemporary European guidelines recommend accelerated diagnostic pathways using a 0/1-hour or 0/2-hour algorithm.
The primary purpose of the DanRUSH trial is to determine whether shortening the interval between serial hs-cTn measurements from 3 hours to 1 hour is both safe and effective in adults presenting with suspected acute coronary syndrome.
The primary safety endpoint is defined as the risk of new (missed or recurrent) myocardial infarction or cardiovascular death after dischage from the index hospitalization -of the 0/1-hour algorithm compared with the 0/3-hour algorithm. Efficacy will be assessed as hospital length of stay, defined as the time from presentation to discharge. The study aims to demonstrate that the 0/1-hour algorithm is non-inferior to the 0/3-hour algorithm with respect to safety while improving efficiency through shorter hospital stays.
The study is designed as a nationwide, pragmatic, open-label, stepped-wedge cluster randomized trial. Participating emergency- and cardiology departments in Denmark will sequentially and randomly transition from the conventional 0/3-hour hs-cTn algorithm to the 0/1-hour hs-cTn algorithm until all sites are exposed to the intervention. A study-specific order set in the electronic medical record will ensure the correct timing of serial blood sampling and facilitate identification of study participants. Relevant baseline and outcome information will be obtained from routinely collected data in the electronic medical record and Danish nationwide health registries.
The results of DanRUSH are expected to provide definitive randomized evidence regarding the safety and effectiveness of the 0/1-hour hs-cTn algorithm. If the accelerated diagnostic strategy is shown to be safe, it may support broader implementation and improve patient flow by reducing unnecessary hospital stays. Conversely, if safety cannot be confirmed, the study may prevent widespread adoption of an insufficiently validated diagnostic strategy.
- Conditions
- Coronary Syndrome, Acute, Myocardial Infarction, Coronary Artery Disease, Cardiovascular Diseases, Cardiovascular Disease Acute
- Being tested
- 0/3-hour high-sensitivity cardiac troponin algorithm, 0/1-hour high-sensitivity cardiac troponin algorithm
- Keywords
- Myocardial infarction, Troponin, Biomarker, Clinical assessment, Myocardial injury, Coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery Disease, Cardiovascular Diseases, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0/3-hour high-sensitivity cardiac troponin algorithmDiagnostic test
High-sensitivity cardiac troponin measurements obtained at presentation and 3 hours after the initial sample as part of the conventional diagnostic strategy for suspected acute coronary syndrome.
0/1-hour high-sensitivity cardiac troponin algorithmDiagnostic test
High-sensitivity cardiac troponin measurements obtained at presentation and 1 hour after the initial sample as part of the accelerated diagnostic strategy for suspected acute coronary syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Conventional 0/3-hour hs-cTn Algorithm | Active comparator | Participants are managed according to the conventional diagnostic strategy for suspected acute coronary syndrome using a 0/3-hour high-sensitivity cardiac troponin (hs-cTn) algorithm. Blood samples are obtained at presentation and 3 hours later in accordance with local clinical practice and study procedures. Receives: Diagnostic Test: 0/3-hour high-sensitivity cardiac troponin algorithm |
| Accelerated 0/1-hour hs-cTn Algorithm | Experimental | Participants are managed according to the accelerated diagnostic strategy for suspected acute coronary syndrome using a 0/1-hour high-sensitivity cardiac troponin (hs-cTn) algorithm. Blood samples are obtained at presentation and 1 hour later in accordance with local clinical practice and study procedures. Receives: Diagnostic Test: 0/1-hour high-sensitivity cardiac troponin algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome: New myocardial infarction or cardiovascular death
The risk of new (missed or recurrent) myocardial infarction or cardiovascular death after dischage -of the 0/1-hour algorithm compared with the 0/3-hour algorithm.
Measured: From discharge from the index hospitalization until 30 days after discharge.
Efficacy outcome: Length of hospital stay
Length of stay, defined as the time from presentation to the emergency department until discharge from hospital.
Measured: During the index hospitalization (from emergency department presentation until hospital discharge)
Secondary outcomes (8)
New myocardial infarction at 12 months
New myocardial infarction within 12 months following discharge from the index hospitalization, excluding myocardial infarction diagnosed during the index hospitalization.
Measured: From discharge from the index hospitalization until 12 months after discharge.
All-cause mortality
Death from any cause following discharge from the index hospitalization
Measured: 30 days and 12 months following discharge
Overall myocardial infarction rate
Occurrence of myocardial infarction during follow-up
Measured: 30 days and 12 months following discharge
Diagnostic coronary angiography
Performance of diagnostic coronary angiography following the index presentation
Measured: During the index hospitalization, at 30 days, and at 12 months after the index presentation
Invasive treatment
Invasive coronary treatment, including percutaneous coronary intervention or coronary artery bypass grafting.
Measured: During the index hospitalization, at 30 days, and at 12 months after the index presentation
Re-presentation to hospital
Presentation to the emergency department or hospital following discharge from the index hospitalization
Measured: 30 days and 12 months following discharge
Re-hospitalization
Hospital admission following discharge from the index hospitalization
Measured: 30 days and 12 months following discharge
Time to treatment initiation
Time from presentation to initiation of relevant treatment for acute coronary syndrome
Measured: From emergency department presentation until initiation of treatment, assessed during the index hospitalization (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Syndrome, AcuteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a nationwide, pragmatic, open-label, stepped-wedge cluster randomized trial. Emergency- and cardiology departments serve as the unit of randomization (clusters). All participating clusters initially apply the control strategy, consisting of a 0/3-hour high-sensitivity cardiac troponin algorithm. Clusters subsequently transition sequentially, in a randomized order, to the intervention strategy, consisting of a 0/1-hour high-sensitivity cardiac troponin algorithm, until all clusters have crossed over to the intervention. Individual participants are exposed to only one of the two diagnostic strategies according to the cluster assignment at the time of presentation.
- Masking
- None (open label)
- Enrolment
- 28,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispeberg and Frederiksberg Hospital, Hvidovre and Amager Hospital, North Zealand (Hillerød) Hospital, Nykøbing Falster Sygehus, Gødstrup Hospital, Regionshospitalet Viborg, Skive, Odense Universitetshospital, Esbjerg sygehus, Aalborg University Hospital
- Responsible party
- Principal investigator, Manan Pareek, Herlev and Gentofte Hospital
- Investigators
- Manan Pareek, MD, MSc PhD, FAHA, FESC, FACC, Principal investigator, Center for Translational Cardiology and Pragmatic Randomized Trials and Department of Cardiology, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727135
- Sponsor's protocol ID
- DanRUSH
- Other IDs
- 2024-12587-22218
- Acronym
- DanRUSH
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 6 Aug 2026
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Randomized Trial of Rapid or Ultra-rapid Diagnosis of Myocardial Infarction Using High-Sensitivity Cardiac Troponin on Hospital Presentation
- ClinicalTrials.gov ID
- NCT07727135
- Acronym / sponsor ID
- DanRUSH / DanRUSH
- Conditions
- Coronary Syndrome, Acute, Myocardial Infarction, Coronary Artery Disease, Cardiovascular Diseases, Cardiovascular Disease Acute
- Keywords
- Myocardial infarction, Troponin, Biomarker, Clinical assessment, Myocardial injury, Coronary syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28,000 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Bispeberg and Frederiksberg Hospital, Hvidovre and Amager Hospital, North Zealand (Hillerød) Hospital, Nykøbing Falster Sygehus, Gødstrup Hospital, Regionshospitalet Viborg, Skive, Odense Universitetshospital, Esbjerg sygehus, Aalborg University Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 27 Jul 2026 (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.
People with chest pain are often tested for a heart attack using a blood test called high-sensitivity cardiac troponin (hs-cTn). Traditionally, this blood test is repeated 3 hours after the first sample. Newer guidelines recommend repeating the test after 1 hour instead, which may allow patients to receive a diagnosis and leave the hospital sooner.
The purpose of the DanRUSH trial is to compare these two strategies: repeating the blood test after 1 hour versus after 3 hours in adults with suspected acute coronary syndrome. The study will evaluate whether the 1-hour strategy is as safe as the 3-hour strategy while reducing the length of hospital stay.
DanRUSH is a nationwide, pragmatic, cluster-randomized trial conducted in emergency- and cardiology departments across Denmark. The results will help determine the best timing for blood testing in patients with suspected heart attack and improve future care for these patients.
Detailed description
Each year, approximately 80,000 individuals present to the Danish healthcare system with chest pain. Of these, around 25,000 are admitted to hospital and approximately 8,000 are diagnosed with acute myocardial infarction. High-sensitivity cardiac troponin (hs-cTn) is the cornerstone biomarker for the diagnosis of myocardial infarction and is essential for the rapid rule-in and rule-out of acute coronary syndromes. Because the diagnosis of myocardial infarction relies not only on troponin concentration but also on changes in troponin levels over time, serial blood sampling is required to distinguish acute myocardial injury from chronic elevations.
Advances in hs-cTn assay sensitivity have enabled progressively shorter intervals between serial blood sampling. Traditionally, most emergency departments have used a 0/3-hour algorithm, in which hs-cTn is measured at presentation and again after 3 hours. However, contemporary European guidelines recommend accelerated diagnostic pathways using a 0/1-hour or 0/2-hour algorithm.
The primary purpose of the DanRUSH trial is to determine whether shortening the interval between serial hs-cTn measurements from 3 hours to 1 hour is both safe and effective in adults presenting with suspected acute coronary syndrome.
The primary safety endpoint is defined as the risk of new (missed or recurrent) myocardial infarction or cardiovascular death after dischage from the index hospitalization -of the 0/1-hour algorithm compared with the 0/3-hour algorithm. Efficacy will be assessed as hospital length of stay, defined as the time from presentation to discharge. The study aims to demonstrate that the 0/1-hour algorithm is non-inferior to the 0/3-hour algorithm with respect to safety while improving efficiency through shorter hospital stays.
The study is designed as a nationwide, pragmatic, open-label, stepped-wedge cluster randomized trial. Participating emergency- and cardiology departments in Denmark will sequentially and randomly transition from the conventional 0/3-hour hs-cTn algorithm to the 0/1-hour hs-cTn algorithm until all sites are exposed to the intervention. A study-specific order set in the electronic medical record will ensure the correct timing of serial blood sampling and facilitate identification of study participants. Relevant baseline and outcome information will be obtained from routinely collected data in the electronic medical record and Danish nationwide health registries.
The results of DanRUSH are expected to provide definitive randomized evidence regarding the safety and effectiveness of the 0/1-hour hs-cTn algorithm. If the accelerated diagnostic strategy is shown to be safe, it may support broader implementation and improve patient flow by reducing unnecessary hospital stays. Conversely, if safety cannot be confirmed, the study may prevent widespread adoption of an insufficiently validated diagnostic strategy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a nationwide, pragmatic, open-label, stepped-wedge cluster randomized trial. Emergency- and cardiology departments serve as the unit of randomization (clusters). All participating clusters initially apply the control strategy, consisting of a 0/3-hour high-sensitivity cardiac troponin algorithm. Clusters subsequently transition sequentially, in a randomized order, to the intervention strategy, consisting of a 0/1-hour high-sensitivity cardiac troponin algorithm, until all clusters have crossed over to the intervention. Individual participants are exposed to only one of the two diagnostic strategies according to the cluster assignment at the time of presentation.
| Arm | Type | Receives |
|---|---|---|
| Conventional 0/3-hour hs-cTn Algorithm | Active comparator | Diagnostic Test: 0/3-hour high-sensitivity cardiac troponin algorithmParticipants are managed according to the conventional diagnostic strategy for suspected acute coronary syndrome using a 0/3-hour high-sensitivity cardiac troponin (hs-cTn) algorithm. Blood samples are obtained at presentation and 3 hours later in accordance with local clinical practice and study procedures. |
| Accelerated 0/1-hour hs-cTn Algorithm | Experimental | Diagnostic Test: 0/1-hour high-sensitivity cardiac troponin algorithmParticipants are managed according to the accelerated diagnostic strategy for suspected acute coronary syndrome using a 0/1-hour high-sensitivity cardiac troponin (hs-cTn) algorithm. Blood samples are obtained at presentation and 1 hour later in accordance with local clinical practice and study procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (≥18 years) presenting with suspected acute coronary syndrome (ACS) with a clinical indication for high-sensitivity cardiac troponin testing
Key exclusion criteria (2 listed)
- Age <18 years.
- ST-segment elevation myocardial infarction (STEMI) identified on the presenting electrocardiogram and requiring immediate reperfusion therapy.
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 |
|---|---|---|
| 0/3-hour high-sensitivity cardiac troponin algorithmHigh-sensitivity cardiac troponin measurements obtained at presentation and 3 hours after the initial sample as part of the conventional diagnostic strategy for suspected acute coronary syndrome. | Diagnostic test | Conventional 0/3-hour hs-cTn Algorithm |
| 0/1-hour high-sensitivity cardiac troponin algorithmHigh-sensitivity cardiac troponin measurements obtained at presentation and 1 hour after the initial sample as part of the accelerated diagnostic strategy for suspected acute coronary syndrome. | Diagnostic test | Accelerated 0/1-hour hs-cTn Algorithm |
Primary outcome
Safety outcome: New myocardial infarction or cardiovascular death
Time frame: From discharge from the index hospitalization until 30 days after discharge.
The risk of new (missed or recurrent) myocardial infarction or cardiovascular death after dischage -of the 0/1-hour algorithm compared with the 0/3-hour algorithm.
Efficacy outcome: Length of hospital stay
Time frame: During the index hospitalization (from emergency department presentation until hospital discharge)
Length of stay, defined as the time from presentation to the emergency department until discharge from hospital.
8 secondary outcomes
New myocardial infarction at 12 months
Time frame: From discharge from the index hospitalization until 12 months after discharge.
All-cause mortality
Time frame: 30 days and 12 months following discharge
Overall myocardial infarction rate
Time frame: 30 days and 12 months following discharge
Diagnostic coronary angiography
Time frame: During the index hospitalization, at 30 days, and at 12 months after the index presentation
Invasive treatment
Time frame: During the index hospitalization, at 30 days, and at 12 months after the index presentation
Re-presentation to hospital
Time frame: 30 days and 12 months following discharge
Re-hospitalization
Time frame: 30 days and 12 months following discharge
Time to treatment initiation
Time frame: From emergency department presentation until initiation of treatment, assessed during the index hospitalization (up to 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- 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.
Manan Pareek, MD, MSc PhD, FAHA, FESC, FACC principal investigator
Center for Translational Cardiology and Pragmatic Randomized Trials and Department of Cardiology, Herlev and Gentofte Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0/3-hour high-sensitivity cardiac troponin algorithm and 0/1-hour high-sensitivity cardiac troponin algorithm in people with Coronary Syndrome, Acute and Myocardial Infarction, run by Herlev and Gentofte Hospital at 11 sites in Denmark.
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 1 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: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Majid Afzal, MD (+45 40 29 26 59, raja.majid.ghafoor.afzal@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcome: New myocardial infarction or cardiovascular death (time frame: From discharge from the index hospitalization until 30 days after discharge.). The study lists 2 primary outcomes in all. 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 6 Aug 2026.