Other Clinical Trial - Clinical & Economic Outcomes of High Sensitivity

Status Completed

Clinical Trial Summary

Myocardial infarction is one of the leading causes of death and disability worldwide. In addition to standard diagnostic methods, it has been shown that high-sensitivity cardiac troponin assays allow greater sensitivity in the diagnosis of myocardial infarction and assume a central role for both exclusion ("rule out") and confirmation ("rule in") of acute myocardial infarction , while allowing to reduce the time interval between ER admission and presumptive diagnosis. Considering the relevance of this topic, we propose to conduct an observational study in real world clinical practice settings at Emergency Departments, aiming to evaluate clinical and economic aspects deriving from the use of the different quantitative assays of high-sensitivity cardiac troponin currently available in patients with suspected acute myocardial infarction and non-ST-elevation ECG (NSTEMI) on the admission, including time of diagnosis and number of laboratory and imaging tests performed.

Clinical Trial Description

Observational, prospective, real-world clinical practice, multicentric study, conducted at 12 Emergency Departments in Italy. Patients with suspected non-ST-elevation myocardial infarction (NSTEMI) who have undergone at least one high-sensitivity cardiac troponin test will be included. Patients will be enrolled in the study after verification of selection criteria. Enrollment is consecutive; each Center will suspend enrollment when it has reached the expected number of patients. An electronic data collection form (eCRF) will be used to automatically generate an enrollment number to identify each patient. Given the observational nature of the study, high-sensitivity cardiac troponin assays will be used according to current clinical practice. Patients will be examined in the ED, and on a 30-day follow-up. ;

Study Design

Related Conditions & MeSH terms

Non-ST Elevated Myocardial Infarction
NSTEMI - Non-ST Segment Elevation MI

Clinical Trial Details

NCT number	NCT03489603
Study type	Observational
Source	Istituto Superiore di Sanità
Contact
Status	Completed
Phase
Start date	October 11, 2017
Completion date	June 15, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical and Economic Outcomes of High Sensitivity Troponin for no ST Elevation Myocardial Infarction in Patients With Chest Pain in Emergency Departments in Italy-An Observational Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms