High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome

Myocardial Infarction Clinical Trial

— High-STEACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852123
• Other study ID #: High-STEACS
• Secondary ID: SP/12/10/29922
• Status: Completed
• Phase: N/A
• Start date: June 10, 2013
• Est. completion date: March 3, 2017

Study information

• Verified date: June 2021
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48282
• Est. completion date: March 3, 2017
• Est. primary completion date: March 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Suspected acute coronary syndrome

• Troponin I measurement as part of routine clinical care

Exclusion criteria:

• None

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Hypersensitivity
• Infarction
• Myocardial Infarction
• Syndrome

Intervention

Device:
• High-sensitivity troponin I assay

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Lothian

Sponsors (4)

Lead Sponsor	Collaborator
University of Edinburgh	Abbott Diagnostics Division, NHS Greater Glasgow and Clyde, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Shah AS, Anand A, Sandoval Y, Lee KK, Smith SW, Adamson PD, Chapman AR, Langdon T, Sandeman D, Vaswani A, Strachan FE, Ferry A, Stirzaker AG, Reid A, Gray AJ, Collinson PO, McAllister DA, Apple FS, Newby DE, Mills NL; High-STEACS investigators. High-sensi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physician diagnosis on discharge		Duration of the index hospital stay, an expected average of 2 weeks
Other	Sensitivity and specificity of sex-specific thresholds for the diagnosis of myocardial infarction		3 months
Other	Evaluate thresholds to rule out myocardial infarction on presentation and change criteria to rule in myocardial infarction with serial sampling.		6 months
Primary	Recurrent myocardial infarction or cardiovascular death at 1 year		1 year
Secondary	Duration of stay	Duration of the index hospital stay, an expected average of 2 weeks	Initial episode
Secondary	Recurrent myocardial infarction		1 year
Secondary	Unplanned coronary revascularization		1 year
Secondary	Cardiovascular death		1 year
Secondary	All cause death		1 year
Secondary	Heart failure hospitalization		1 year
Secondary	Major hemorrhage		1 year
Secondary	Minor hemorrhage		1 year
Secondary	Recurrent unplanned hospitalization excluding acute coronary syndrome		30 days
Secondary	Non-cardiovascular death		1 year