Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SB, United Kingdom
NCT Number: NCT01852123
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Edinburgh, Lothian, EH16 4SB, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: ARCHITECT STAT high-sensitive troponin I assay
Time frame: 1 year
Time frame: Initial episode
Duration of the index hospital stay, an expected average of 2 weeks
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 30 days
Time frame: 1 year
Time frame: Duration of the index hospital stay, an expected average of 2 weeks
Time frame: 3 months
Time frame: 6 months
University of Edinburgh
Other
High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome: A Randomized Controlled Trial
Acronym: High-STEACS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04475380
Acute Coronary Syndrome, Angina Pectoris
Enschede, Netherlands
View Trial DetailsNCT06404515
ASCVD, Acute Coronary Syndrome
New York, United States
View Trial DetailsNCT04125992
Acute Coronary Syndrome, Angina Pectoris
Nablus, Palestinian Territories
View Trial DetailsNCT04231097
Acute Coronary Syndrome, Angina Pectoris
Boston, Massachusetts, United States
View Trial Details