VITROS Immunodiagnostic Products hs Troponin I

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03581578

Enrollment

1630

Registered

2018-07-10

Start date

2018-06-07

Completion date

2021-06-30

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome (ACS), Myocardial Infarction

Keywords

Troponin

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity of the VITROS hs Troponin I test	VITROS hs Troponin I value at baseline	Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).

Secondary

Measure	Time frame	Description
Risk stratification of subjects	Up to 12 months after last enrollment	Assess the use of cardiac Troponin I measurement in the risk stratification of subjects.
Rule in and rule out myocardial infarction (MI)	VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours)	Evaluate the VITROS hs Troponin I test to rule in and rule out MI.

Countries

United States

Outcome results