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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03581578
Other study ID # 16-002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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)
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