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

NCT07727135 | Not Yet Recruiting

• 2 other identifiers: DanRUSH2024-12587-22218
• Study Type: interventional
• Target: 28,000
• Locations: 1 country
• Sites: 11

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• Safety outcome: new myocardial infarction

  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

  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 Outcomes (8)

• New myocardial infarction at 12 months

  From discharge from the index hospitalization until 12 months after discharge.

• All-cause mortality

  30 days and 12 months following discharge

• Overall myocardial infarction rate

  30 days and 12 months following discharge

• Diagnostic coronary angiography

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

• Invasive treatment

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

Study Arms (2)

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.

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.

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

Interventions

0/3-hour high-sensitivity cardiac troponin algorithm DIAGNOSTIC_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.

Conventional 0/3-hour hs-cTn Algorithm

0/1-hour high-sensitivity cardiac troponin algorithm DIAGNOSTIC_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.

Accelerated 0/1-hour hs-cTn Algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (11)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Bispebjerg & Frederiksberg Hospital

Bispebjerg, 2400, Denmark

Location

Esbjerg og Grindsted Sygehus

Esbjerg, 6700, Denmark

Location

Gødstrup Regional Hospital

Gødstrup, 7400, Denmark

Location

Herlev & Gentofte Hospital

Herlev, 2730, Denmark

Location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Amager & Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Nykøbing Falster County Hospital

Nykøbing Falster, 4800, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Svendborg Hospital

Svendborg, 5700, Denmark

Location

Central Jutland Regional Hospital (Viborg Hospital & Silkeborg Hospital)

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Coronary Artery Disease; Cardiovascular Diseases; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Manan Pareek, MD, MSc PhD, FAHA, FESC, FACC

  Center for Translational Cardiology and Pragmatic Randomized Trials and Department of Cardiology, Herlev and Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Majid Afzal, MD

CONTACT

+45 40 29 26 59; raja.majid.ghafoor.afzal@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, PhD, FAHA, FESC, Senior researcher

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

DK (11)