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
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.
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.
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 →Herlev and Gentofte Hospital is the lead sponsor of 75 studies on the registry; 25 are open to participants now.
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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.
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
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
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.
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.
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.
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)
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.
All-cause mortality
Death from any cause following discharge from the index hospitalization
Time frame: 30 days and 12 months following discharge
Overall myocardial infarction rate
Occurrence of myocardial infarction during follow-up
Time frame: 30 days and 12 months following discharge
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
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
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
Re-hospitalization
Hospital admission following discharge from the index hospitalization
Time frame: 30 days and 12 months following discharge
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)
Plan to share: Undecided
No publications or documents are linked to this record.
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.
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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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Herlev and Gentofte Hospital