ClinicalTrials.gg
Not yet recruitingNCT07727135DanRUSHUpdated Aug 6, 2026

Rapid or Ultra-rapid Diagnosis of Myocardial Infarction Using High-Sensitivity Cardiac Troponin on Hospital Presentation

An interventional study of 0/3-hour high-sensitivity cardiac troponin algorithm and 0/1-hour high-sensitivity cardiac troponin algorithm in Coronary Syndrome, Acute, Myocardial Infarction and Coronary Artery Disease, sponsored by Herlev and Gentofte Hospital. Not yet recruiting at 11 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Herlev and Gentofte Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
28,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Coronary Syndrome, Acute
  • Myocardial Infarction
  • Coronary Artery Disease
  • Cardiovascular Diseases
  • Cardiovascular Disease Acute

Keywords

  • Myocardial infarction
  • Troponin
  • Biomarker
  • Clinical assessment
  • Myocardial injury
  • Coronary syndrome
03

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's planned enrollment of 28,000 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Herlev and Gentofte Hospital is the lead sponsor of 75 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Adults (≥18 years) presenting with suspected acute coronary syndrome (ACS) with a clinical indication for high-sensitivity cardiac troponin testing

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years.
  • ST-segment elevation myocardial infarction (STEMI) identified on the presenting and requiring immediate reperfusion therapy.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28,000 participants (estimated)

Study arms

  • Active comparator
    Conventional 0/3-hour hs-cTn Algorithm

    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.

    Diagnostic Test: 0/3-hour high-sensitivity cardiac troponin algorithm

  • Experimental
    Accelerated 0/1-hour hs-cTn Algorithm

    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.

    Diagnostic Test: 0/1-hour high-sensitivity cardiac troponin algorithm

Interventions

  • Diagnostic test0/3-hour high-sensitivity cardiac troponin algorithm

    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.

  • Diagnostic test0/1-hour high-sensitivity cardiac troponin algorithm

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From discharge from the index hospitalization until 30 days after discharge.

  2. Efficacy outcome: Length of hospital stay

    Length of stay, defined as the time from presentation to the emergency department until discharge from hospital.

    Time frame: During the index hospitalization (from emergency department presentation until hospital discharge)

Secondary outcomes

  1. 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.

    Time frame: From discharge from the index hospitalization until 12 months after discharge.

  2. All-cause mortality

    Death from any cause following discharge from the index hospitalization

    Time frame: 30 days and 12 months following discharge

  3. Overall myocardial infarction rate

    Occurrence of myocardial infarction during follow-up

    Time frame: 30 days and 12 months following discharge

  4. Diagnostic coronary angiography

    Performance of diagnostic coronary angiography following the index presentation

    Time frame: During the index hospitalization, at 30 days, and at 12 months after the index presentation

  5. Invasive treatment

    Invasive coronary treatment, including percutaneous coronary intervention or coronary artery bypass grafting.

    Time frame: During the index hospitalization, at 30 days, and at 12 months after the index presentation

  6. Re-presentation to hospital

    Presentation to the emergency department or hospital following discharge from the index hospitalization

    Time frame: 30 days and 12 months following discharge

  7. Re-hospitalization

    Hospital admission following discharge from the index hospitalization

    Time frame: 30 days and 12 months following discharge

  8. Time to treatment initiation

    Time from presentation to initiation of relevant treatment for acute coronary syndrome

    Time frame: From emergency department presentation until initiation of treatment, assessed during the index hospitalization (up to 7 days)

07

Study locations

11 sites
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.

Of 210 non-industry interventional studies with no phase under Acute Coronary Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 46. This study's planned 24 months is below that.

Counting every sponsor, half of 225 studies reached it within 34 months; a quarter within 18 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2026
First posted
Jul 27, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2028
CompletionEst.
Feb 1, 2029
Last update
Aug 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07727135
Lead sponsor
Herlev and Gentofte Hospital
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
Manan Pareek (MD, MSc, PhD, FAHA, FESC, Senior researcher, Herlev and Gentofte Hospital) — Principal investigator
First posted
Jul 27, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2028 (estimated)
Completion
Feb 1, 2029 (estimated)
Last update
Aug 6, 2026

Study contacts

Majid Afzal, MD
Contact
raja.majid.ghafoor.afzal@regionh.dk
+45 40 29 26 59
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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