Clinical trial NCT02620397: Clinical Study to Validate the Use of a New Point of Care Troponin I Test
Official title: Clinical Study to Validate the Use of a New Point of Care Troponin I Test as an Aid in the Diagnosis of Myocardial Infarction and Prognosis of Subjects Presenting With Symptoms of Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Lead sponsor: Trinity Biotech
Sponsor class: INDUSTRY
First posted: 2015-12-03
Enrollment: 1500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 1000 to 1500 adult subjects presenting to emergency departments (ED) with symptoms suggestive of acute coronary sydrome (ACS) and/or myocardial ischemia

Brief summary: This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating emergency departments with symptoms suggestive of acute coronary syndrome (ACS)

Detailed description: This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating Emergency Departments (EDs) with symptoms suggestive of ACS and/or myocardial ischemia. Subjects presenting with symptoms suggestive of ACS will be screened and approached for consent for study enrollment by trained personnel.

After obtaining written informed consent, subjects will have up to 4 blood samples collected for cTnI testing using the Meritas Troponin I test and Meritas point-of-care (POC) Analyzer. Blood draws and testing will occur at 4 intervals over 24 hours.

Eligibility criteria: Inclusion Criteria:

1. The informed consent must be signed by the subject, or the subject's legal authorized representative.
2. 21 years of age or greater at the time of enrollment
3. Subjects presenting to the ED with any symptoms suggestive of ACS and/or myocardial ischemia, such as but not limited to: subjects currently having chest pain, pressure or a burning sensation across the precordium and epigastrium, pain that radiates to neck, shoulder, jaw, back, upper abdomen and either arm.

Exclusion Criteria:

1. Informed consent form not signed
2. Age \<21 years
3. Known pregnancy -

Primary outcomes:
measure: Clinical performance of the Meritas Troponin I test
timeFrame: 24-hours
Secondary outcomes:
measure: Prognostic capability of sponsor's Meritas Troponin I to predict mortality (all-cause death) and cardiac events (i.e., MI, cardiac death).
timeFrame: 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital & Trauma Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Idaho Falls
country: United States
facility: Eastern Idaho Regional Medical Center
state: Idaho
city: Louisville
country: United States
facility: Kentucky Clinical Trials Laboratories
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Minneapolis
country: United States
facility: Hennepin County Medical Ctr
state: Minnesota
city: Las Vegas
country: United States
facility: Sunrise Hospital
state: Nevada
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson Univeristy
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Ben Taub
state: Texas
Study officials:
affiliation: Trinity Biotech
name: Jim Rock
role: STUDY_DIRECTOR
References: