Clinical trial NCT03581578: VITROS Immunodiagnostic Products hs Troponin I
Official title: VITROS Immunodiagnostic Products hs Troponin I
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome (ACS)
Myocardial Infarction
Keywords: Troponin
Lead sponsor: Ortho-Clinical Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-10
Enrollment: 1630
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity of the VITROS hs Troponin I test
timeFrame: VITROS hs Troponin I value at baseline
measure: Sensitivity and specificity of the VITROS hs Troponin I test
timeFrame: VITROS hs Troponin I value > 1 hour and up to 3 hours
measure: Sensitivity and specificity of the VITROS hs Troponin I test
timeFrame: VITROS hs Troponin I value at > 3 hours and up to 6 hours
measure: Sensitivity and specificity of the VITROS hs Troponin I test
timeFrame: VITROS hs Troponin I value at > 6 hours and up to 9 hours
Secondary outcomes:
measure: Risk stratification of subjects
timeFrame: Up to 12 months after last enrollment
measure: Rule in and rule out myocardial infarction (MI)
timeFrame: VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours)
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Drug Research and Analysis Corp
state: Alabama
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University/Detroit Receiving Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center/Minneapolis Medical Research Foundation
state: Minnesota
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Oregon Health Science University Hospital
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center El Paso
state: Texas
city: Houston
country: United States
facility: Ben Taub General Hospital / Baylor College of Medicine/Harris Health System
state: Texas
city: Alexandria
country: United States
facility: INOVA Alexandria Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin and Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: Fred Apple, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health System
name: Richard Nowak, MD
role: PRINCIPAL_INVESTIGATOR
References: