Clinical Study to Validate the Use of a New Point of Care Troponin I Test

Status unconfirmed

Conditions studied: Acute Coronary Syndrome

In brief

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)

Key facts

Study ID

NCT02620397

Run by

Trinity Biotech

People needed

1500

Starts

2015-03-01

Expected to finish

2016-11-01

Last updated by the study team

2015-12-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The informed consent must be signed by the subject, or the subject's legal authorized representative.
• 21 years of age or greater at the time of enrollment
• 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.

You may not qualify if…

• Informed consent form not signed
• Age <21 years
• Known pregnancy -

Where it is running

• San Francisco General Hospital & Trauma Center — San Francisco, California, United States
• University of Florida — Gainesville, Florida, United States
• Eastern Idaho Regional Medical Center — Idaho Falls, Idaho, United States
• Kentucky Clinical Trials Laboratories — Louisville, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Maryland — Baltimore, Maryland, United States
• Hennepin County Medical Ctr — Minneapolis, Minnesota, United States
• Sunrise Hospital — Las Vegas, Nevada, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• Thomas Jefferson Univeristy — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Ben Taub — Houston, Texas, United States

Full record on ClinicalTrials.gov

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