VITROS Immunodiagnostic Products hs Troponin I

Ortho-Clinical Diagnostics

Status: Unknown

Conditions: Myocardial Infarction; Acute Coronary Syndrome (ACS)

Study type: Observational

Funder types: Industry

Identifiers

NCT03581578

16-002

Details and patient eligibility

About

The purpose of this clinical study is to collect data to substantiate the use of the VITROS hs Troponin I test as an aid in the diagnosis of myocardial infarction (MI). The test is further indicated for risk stratification of mortality, myocardial infarction or coronary revascularization in patients with acute coronary syndrome.

Full description

A prospective clinical sample collection and cardiac troponin I testing will be conducted in individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS) at geographically dispersed sites in the US. Individuals who meet the inclusion/exclusion criteria, including having signed an informed consent form will be included in the study.

Clinical and laboratory data will be collected to demonstrate product performance compared to an adjudicated clinical diagnosis.

Sample collection and testing of clinical samples with the VITROS hs Troponin I test will be performed under two separate protocols.

Enrollment: 1,630 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject must be ≥22 years of age at the time of consent.
2. Subject presenting with symptoms suggestive of acute coronary syndrome including chest pain, or chest pain equivalent.
3. Must have an Electrocardiogram (ECG) ordered as part of the subject's standard of care.
4. Subject willing and able to provide informed consent.

Exclusion criteria

1. Subject is unable to comply with the study requirements.
2. Any samples which were not obtained under IRB approved protocol.