VITROS Immunodiagnostic Products hs Troponin I

Myocardial Infarction Clinical Trial

Official title:

VITROS Immunodiagnostic Products hs Troponin I

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03581578
• Other study ID #: 16-002
• Status: Active, not recruiting
• Start date: June 7, 2018
• Est. completion date: June 2021

Study information

• Verified date: September 2020
• Source: Ortho-Clinical Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1630
• Est. completion date: June 2021
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	INOVA Alexandria Hospital	Alexandria	Virginia
United States	University of Maryland	Baltimore	Maryland
United States	Mass General Hospital	Boston	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	Chandler Regional Medical Center	Chandler	Arizona
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Wayne State University/Detroit Receiving Hospital	Detroit	Michigan
United States	Texas Tech University Health Sciences Center El Paso	El Paso	Texas
United States	Ben Taub General Hospital / Baylor College of Medicine/Harris Health System	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Medical College of Wisconsin and Froedtert Hospital	Milwaukee	Wisconsin
United States	Hennepin County Medical Center/Minneapolis Medical Research Foundation	Minneapolis	Minnesota
United States	Drug Research and Analysis Corp	Montgomery	Alabama
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Oregon Health Science University Hospital	Portland	Oregon
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Beaumont	Royal Oak	Michigan
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ortho-Clinical Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the VITROS hs Troponin I test	Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).	VITROS hs Troponin I value at baseline
Primary	Sensitivity and specificity of the VITROS hs Troponin I test	Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).	VITROS hs Troponin I value > 1 hour and up to 3 hours
Primary	Sensitivity and specificity of the VITROS hs Troponin I test	Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).	VITROS hs Troponin I value at > 3 hours and up to 6 hours
Primary	Sensitivity and specificity of the VITROS hs Troponin I test	Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).	VITROS hs Troponin I value at > 6 hours and up to 9 hours
Secondary	Risk stratification of subjects	Assess the use of cardiac Troponin I measurement in the risk stratification of subjects.	Up to 12 months after last enrollment
Secondary	Rule in and rule out myocardial infarction (MI)	Evaluate the VITROS hs Troponin I test to rule in and rule out MI.	VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours)