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

NCT02620397 | Unknown

• 1 other identifier: CP7001_5ACS
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 14

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)

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Clinical performance of the Meritas Troponin I test

  Clinical performance indicators (Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) and their respective 95 % confidence intervals (CIs) will be calculated for the quantitative determination of cardiac troponin I (cTnI) for use as an aid in the diagnosis of myocardial infarction (MI)

  24-hours

Secondary Outcomes (1)

• Prognostic capability of sponsor's Meritas Troponin I to predict mortality (all-cause death) and cardiac events (i.e., MI, cardiac death).

  1 year

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• The informed consent must be signed by the subject, or the subject's legal authorized representative.
• 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 -

Sponsors & Collaborators

• Trinity Biotech: lead

Study Sites (14)

San Francisco General Hospital & Trauma Center

San Francisco, California, 94110, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Eastern Idaho Regional Medical Center

Idaho Falls, Idaho, 83404, United States

Location

Kentucky Clinical Trials Laboratories

Louisville, Kentucky, 40202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Hennepin County Medical Ctr

Minneapolis, Minnesota, 55404, United States

Location

Sunrise Hospital

Las Vegas, Nevada, 89109, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28293, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Thomas Jefferson Univeristy

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Ben Taub

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA Whole Blood

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jim Rock

  Trinity Biotech

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: December 3, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2016
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

US (14)