High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome (High-STEACS)
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ClinicalTrials.gov Identifier: NCT01852123 |
Recruitment Status :
Completed
First Posted : May 13, 2013
Last Update Posted : June 24, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Coronary Syndrome Myocardial Infarction | Device: High-sensitivity troponin I assay | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48282 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome: A Randomized Controlled Trial |
Actual Study Start Date : | June 10, 2013 |
Actual Primary Completion Date : | March 3, 2017 |
Actual Study Completion Date : | March 3, 2017 |

Arm | Intervention/treatment |
---|---|
Early implementation
The high-sensitivity troponin I assay will be implemented after a 6 month validation phase
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Device: High-sensitivity troponin I assay
Other Name: ARCHITECT STAT high-sensitive troponin I assay |
Late implementation
The high-sensitivity troponin I assay will be implemented after a 12 month validation phase
|
Device: High-sensitivity troponin I assay
Other Name: ARCHITECT STAT high-sensitive troponin I assay |
- Recurrent myocardial infarction or cardiovascular death at 1 year [ Time Frame: 1 year ]
- Duration of stay [ Time Frame: Initial episode ]Duration of the index hospital stay, an expected average of 2 weeks
- Recurrent myocardial infarction [ Time Frame: 1 year ]
- Unplanned coronary revascularization [ Time Frame: 1 year ]
- Cardiovascular death [ Time Frame: 1 year ]
- All cause death [ Time Frame: 1 year ]
- Heart failure hospitalization [ Time Frame: 1 year ]
- Major hemorrhage [ Time Frame: 1 year ]
- Minor hemorrhage [ Time Frame: 1 year ]
- Recurrent unplanned hospitalization excluding acute coronary syndrome [ Time Frame: 30 days ]
- Non-cardiovascular death [ Time Frame: 1 year ]
- Physician diagnosis on discharge [ Time Frame: Duration of the index hospital stay, an expected average of 2 weeks ]
- Sensitivity and specificity of sex-specific thresholds for the diagnosis of myocardial infarction [ Time Frame: 3 months ]
- Evaluate thresholds to rule out myocardial infarction on presentation and change criteria to rule in myocardial infarction with serial sampling. [ Time Frame: 6 months ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Suspected acute coronary syndrome
- Troponin I measurement as part of routine clinical care
Exclusion criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852123
United Kingdom | |
Royal Infirmary of Edinburgh | |
Edinburgh, Lothian, United Kingdom, EH16 4SB |
Principal Investigator: | Nicholas L Mills, MD, PhD | University of Edinburgh | |
Study Chair: | Ian Ford, PhD | University of Glasgow |
Documents provided by University of Edinburgh:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT01852123 |
Other Study ID Numbers: |
High-STEACS SP/12/10/29922 ( Other Grant/Funding Number: British Heart Foundation ) |
First Posted: | May 13, 2013 Key Record Dates |
Last Update Posted: | June 24, 2021 |
Last Verified: | June 2021 |
High-sensitivity troponin assay Myocardial infarction Unstable angina Myocardial injury Cluster randomized trial |
Myocardial Infarction Acute Coronary Syndrome Hypersensitivity Syndrome Infarction Disease Pathologic Processes |
Ischemia Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Immune System Diseases |