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NCT07636642Recruiting

Sixth Generation High-sensitivity Cardiac Troponin T for the Early Rule Out of Myocardial Infarction: a Controlled Before and After Study

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

Cardiac troponin is a protein released into the blood when the heart muscle is damaged. Measuring this protein helps doctors diagnose a heart attack (also called a myocardial infarction). Modern blood tests, known as high-sensitivity cardiac troponin assays, can detect very small amounts of this protein. A new version of this test, called Troponin T high-sensitivity Gen 6, has recently been developed and approved for use. It is designed to be more accurate and reliable, detecting smaller changes in troponin levels and being less affected by technical interference. The investigators believe this improved test will allow doctors to diagnose heart attacks more quickly and decide sooner who needs to stay in hospital and who can safely go home. This could help reduce overcrowding in Accident and Emergency (A\&E) departments, a major challenge for the NHS. This study will examine whether switching to this new test across a health board shortens the time patients with suspected heart attacks spend in the Emergency Department. The investigators will use information from the DataLoch Heart Disease Registry, which automatically collects anonymised hospital data for patients attending with possible heart attacks. The investigators will compare data from one year before and one year after implementation to see whether average length of stay changes and to confirm that patient safety remains high. This investigators will also measure both the current and new versions of the troponin test in surplus blood samples collected during two six-month periods-one before and one after the new test is introduced. This will allows the investigators to directly compare the two tests reliably. Patients will not need to do anything extra to take part - the study uses information and samples already collected as part of their usual care.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
19500 (estimated)
First submitted
22 May 2026
Start date
1 Jun 2026
Primary completion date
May 2028
Lead sponsor
University of Edinburgh
NCT number
NCT07636642

What you commit to

  • Study type: Interventional
  • Planned participants: 19500
  • From 1 Jun 2026 to the primary completion date, May 2028
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous enrolment in the study.

Other

  • Insufficient clinical information to perform record linkage.
  • Not resident in Scotland.

Who the study is looking for

  • Age 18 years and over.
  • Attending clinician suspects acute coronary syndrome.
  • At least one measurement of cardiac troponin using the Gen 5 or Gen 6 hs-cTnT assay.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Royal Infirmary of Edinburgh
Coordinator of this site? Confirm its status
EdinburghUnited KingdomRecruiting
Western General Hospital
Coordinator of this site? Confirm its status
EdinburghUnited KingdomRecruiting
St John's Hospital
Coordinator of this site? Confirm its status
LivingstonUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.