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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01852123
First Posted: May 13, 2013
Last Update Posted: November 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
NHS Lothian
NHS Greater Glasgow and Clyde
Abbott Diagnostics Division
Information provided by (Responsible Party):
University of Edinburgh
April 29, 2013
May 13, 2013
November 3, 2016
May 2013
March 2017   (Final data collection date for primary outcome measure)
Recurrent myocardial infarction or cardiovascular death at 1 year [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01852123 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
  • 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 ]
  • 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 ]
 
High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome
High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome: A Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Acute Coronary Syndrome
  • Myocardial Infarction
Device: High-sensitivity troponin I assay
Other Name: ARCHITECT STAT high-sensitive troponin I assay
  • Early implementation
    The high-sensitivity troponin I assay will be implemented after a 6 month validation phase
    Intervention: Device: High-sensitivity troponin I assay
  • Late implementation
    The high-sensitivity troponin I assay will be implemented after a 12 month validation phase
    Intervention: Device: High-sensitivity troponin I assay
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-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: a cohort study. Lancet. 2015 Dec 19;386(10012):2481-8. doi: 10.1016/S0140-6736(15)00391-8. Epub 2015 Oct 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70000
March 2017
March 2017   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Suspected acute coronary syndrome
  • Troponin I measurement as part of routine clinical care

Exclusion criteria:

- None

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01852123
High-STEACS
SP/12/10/29922 ( Other Grant/Funding Number: British Heart Foundation )
Yes
Not Provided
Not Provided
University of Edinburgh
University of Edinburgh
  • NHS Lothian
  • NHS Greater Glasgow and Clyde
  • Abbott Diagnostics Division
Principal Investigator: Nicholas L Mills, MD, PhD University of Edinburgh
Study Chair: Ian Ford, PhD University of Glasgow
University of Edinburgh
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP