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Clinical Trials/NCT01852123
NCT01852123CompletedNot Applicable

High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome: A Randomized Controlled Trial

University of Edinburgh2 sites in 1 country48,282 target enrollmentStarted: June 10, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48,282
Locations
2
Primary Endpoint
Recurrent myocardial infarction or cardiovascular death at 1 year

Study Overview

Brief Summary

In patients with chest pain the diagnosis of a heart attack (myocardial infarction) is made where there is evidence of heart muscle damage using a blood test to measure the heart muscle protein troponin. A new a more sensitive troponin test may help us to identify patients with myocardial infarction more easily.

The investigators propose to evaluate whether use of a novel high-sensitivity troponin test to lower the threshold for diagnosis of myocardial infarction is appropriate. If increased sensitivity does not reduce specificity for the diagnosis, then this new test will improve patient outcome through better targeting of therapies for coronary heart disease. However, if increased sensitivity leads to poor specificity, then patients may be misdiagnosed and given inappropriate cardiac medications with potentially detrimental outcomes.

In ten secondary and tertiary care hospitals across Scotland, the investigators will undertake a stepped wedge cluster randomized controlled trial of the implementation of a novel high-sensitivity troponin test. The primary end-point will be the one-year rate of cardiovascular death or recurrent myocardial infarction. This will establish whether the introduction of this high-sensitivity troponin test into routine clinical practice is beneficial to patient management and outcomes.

A subset of patients will be asked to give consent for inclusion into a sub-study that will permit storage of blood samples and will require the completion of a survey during the index admission and after 6 and 12 months of follow up.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Diagnostic
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Recurrent myocardial infarction or cardiovascular death at 1 year

Time Frame: 1 year

Secondary Outcomes

  • Cardiovascular death(1 year)
  • All cause death(1 year)
  • Minor hemorrhage(1 year)
  • Recurrent unplanned hospitalization excluding acute coronary syndrome(30 days)
  • Duration of stay(Initial episode)
  • Recurrent myocardial infarction(1 year)
  • Unplanned coronary revascularization(1 year)
  • Major hemorrhage(1 year)
  • Non-cardiovascular death(1 year)
  • Heart failure hospitalization(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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