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

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.
 
ClinicalTrials.gov Identifier: NCT01852123
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : June 24, 2021
Sponsor:
Collaborators:
NHS Lothian
NHS Greater Glasgow and Clyde
Abbott Diagnostics Division
Information provided by (Responsible Party):
University of Edinburgh

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Myocardial Infarction Device: High-sensitivity troponin I assay Not Applicable

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Early implementation
The high-sensitivity troponin I assay will be implemented after a 6 month validation phase
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




Primary Outcome Measures :
  1. Recurrent myocardial infarction or cardiovascular death at 1 year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Duration of stay [ Time Frame: Initial episode ]
    Duration of the index hospital stay, an expected average of 2 weeks

  2. Recurrent myocardial infarction [ Time Frame: 1 year ]
  3. Unplanned coronary revascularization [ Time Frame: 1 year ]
  4. Cardiovascular death [ Time Frame: 1 year ]
  5. All cause death [ Time Frame: 1 year ]
  6. Heart failure hospitalization [ Time Frame: 1 year ]
  7. Major hemorrhage [ Time Frame: 1 year ]
  8. Minor hemorrhage [ Time Frame: 1 year ]
  9. Recurrent unplanned hospitalization excluding acute coronary syndrome [ Time Frame: 30 days ]
  10. Non-cardiovascular death [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Physician diagnosis on discharge [ Time Frame: Duration of the index hospital stay, an expected average of 2 weeks ]
  2. Sensitivity and specificity of sex-specific thresholds for the diagnosis of myocardial infarction [ Time Frame: 3 months ]
  3. Evaluate thresholds to rule out myocardial infarction on presentation and change criteria to rule in myocardial infarction with serial sampling. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

- None


Information from the National Library of Medicine

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


Locations
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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom, EH16 4SB
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
NHS Greater Glasgow and Clyde
Abbott Diagnostics Division
Investigators
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Principal Investigator: Nicholas L Mills, MD, PhD University of Edinburgh
Study Chair: Ian Ford, PhD University of Glasgow
  Study Documents (Full-Text)

Documents provided by University of Edinburgh:
Study Protocol  [PDF] May 16, 2018
Statistical Analysis Plan  [PDF] May 16, 2018

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Neumann JT, Twerenbold R, Ojeda F, Sorensen NA, Chapman AR, Shah ASV, Anand A, Boeddinghaus J, Nestelberger T, Badertscher P, Mokhtari A, Pickering JW, Troughton RW, Greenslade J, Parsonage W, Mueller-Hennessen M, Gori T, Jernberg T, Morris N, Liebetrau C, Hamm C, Katus HA, Munzel T, Landmesser U, Salomaa V, Iacoviello L, Ferrario MM, Giampaoli S, Kee F, Thorand B, Peters A, Borchini R, Jorgensen T, Soderberg S, Sans S, Tunstall-Pedoe H, Kuulasmaa K, Renne T, Lackner KJ, Worster A, Body R, Ekelund U, Kavsak PA, Keller T, Lindahl B, Wild P, Giannitsis E, Than M, Cullen LA, Mills NL, Mueller C, Zeller T, Westermann D, Blankenberg S; COMPASS-MI Study Group. Application of High-Sensitivity Troponin in Suspected Myocardial Infarction. N Engl J Med. 2019 Jun 27;380(26):2529-2540. doi: 10.1056/NEJMoa1803377. Erratum In: N Engl J Med. 2022 Nov 3;387(18):1724.

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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
Keywords provided by University of Edinburgh:
High-sensitivity troponin assay
Myocardial infarction
Unstable angina
Myocardial injury
Cluster randomized trial
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Hypersensitivity
Syndrome
Infarction
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Immune System Diseases