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

July 22, 2026 updated by: Manan Pareek, Herlev and Gentofte Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

28000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Bispebjerg, Denmark, 2400
        • Bispebjerg & Frederiksberg Hospital
      • Esbjerg, Denmark, 6700
        • Esbjerg og Grindsted Sygehus
      • Gødstrup, Denmark, 7400
        • Gødstrup Regional Hospital
      • Herlev, Denmark, 2730
        • Herlev & Gentofte Hospital
      • Hillerød, Denmark, 3400
        • Nordsjællands Hospital
      • Hvidovre, Denmark, 2650
        • Amager & Hvidovre Hospital
      • Nykøbing Falster, Denmark, 4800
        • Nykøbing Falster County Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Svendborg, Denmark, 5700
        • Svendborg Hospital
      • Viborg, Denmark, 8800
        • Central Jutland Regional Hospital (Viborg Hospital & Silkeborg Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age <18 years.
  • ST-segment elevation myocardial infarction (STEMI) identified on the presenting electrocardiogram and requiring immediate reperfusion therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety outcome: new myocardial infarction
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.
From discharge from the index hospitalization until 30 days after discharge.
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.
During the index hospitalization (from emergency department presentation until hospital discharge)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New myocardial infarction at 12 months
Time Frame: From discharge from the index hospitalization until 12 months after discharge.
New myocardial infarction within 12 months following discharge from the index hospitalization, excluding myocardial infarction diagnosed during the index hospitalization.
From discharge from the index hospitalization until 12 months after discharge.
All-cause mortality
Time Frame: 30 days and 12 months following discharge
Death from any cause following discharge from the index hospitalization
30 days and 12 months following discharge
Overall myocardial infarction rate
Time Frame: 30 days and 12 months following discharge
Occurrence of myocardial infarction during follow-up
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
Performance of diagnostic coronary angiography following the index presentation
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
Invasive coronary treatment, including percutaneous coronary intervention or coronary artery bypass grafting.
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
Presentation to the emergency department or hospital following discharge from the index hospitalization
30 days and 12 months following discharge
Re-hospitalization
Time Frame: 30 days and 12 months following discharge
Hospital admission following discharge from the index hospitalization
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)
Time from presentation to initiation of relevant treatment for acute coronary syndrome
From emergency department presentation until initiation of treatment, assessed during the index hospitalization (up to 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev and Gentofte Hospital

Collaborators

Aalborg University Hospital
Regionshospitalet Viborg, Skive
Gødstrup Hospital
Nykøbing Falster Sygehus
Bispeberg and Frederiksberg Hospital
Hvidovre and Amager Hospital
North Zealand (Hillerød) Hospital
Odense Universitetshospital
Esbjerg sygehus

Investigators

  • Principal Investigator: Manan Pareek, MD, MSc PhD, FAHA, FESC, FACC, Center for Translational Cardiology and Pragmatic Randomized Trials and Department of Cardiology, Herlev and Gentofte Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DanRUSH
  • 2024-12587-22218 (Other Grant/Funding Number: Hjerteforeningen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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