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Trial record 78 of 636 for:    test AND point-of-care

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

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ClinicalTrials.gov Identifier: NCT02620397
Recruitment Status : Unknown
Verified December 2015 by Trinity Biotech.
Recruitment status was:  Active, not recruiting
First Posted : December 3, 2015
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Trinity Biotech

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)

Condition or disease
Acute Coronary Syndrome

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.


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Study Type : Observational
Estimated Enrollment : 1500 participants
Time Perspective: Prospective
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 Start Date : March 2015
Actual Primary Completion Date : October 2015
Estimated Study Completion Date : November 2016



Primary Outcome Measures :
  1. Clinical performance of the Meritas Troponin I test [ Time Frame: 24-hours ]
    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)


Secondary Outcome Measures :
  1. Prognostic capability of sponsor's Meritas Troponin I to predict mortality (all-cause death) and cardiac events (i.e., MI, cardiac death). [ Time Frame: 1 year ]
    Kaplan-Meier survival curves and risk ratios. A multivariate Cox proportional model with known risk factors as covariates in addition to the Troponin test result will be included in the data analysis


Biospecimen Retention:   Samples Without DNA
EDTA Whole Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620397


Locations
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United States, California
San Francisco General Hospital & Trauma Center
San Francisco, California, United States, 94110
United States, Florida
University of Florida
Gainesville, Florida, United States, 32608
United States, Idaho
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, United States, 83404
United States, Kentucky
Kentucky Clinical Trials Laboratories
Louisville, Kentucky, United States, 40202
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Minnesota
Hennepin County Medical Ctr
Minneapolis, Minnesota, United States, 55404
United States, Nevada
Sunrise Hospital
Las Vegas, Nevada, United States, 89109
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28293
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Thomas Jefferson Univeristy
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Ben Taub
Houston, Texas, United States, 77030
Sponsors and Collaborators
Trinity Biotech
Investigators
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Study Director: Jim Rock Trinity Biotech

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Responsible Party: Trinity Biotech
ClinicalTrials.gov Identifier: NCT02620397     History of Changes
Other Study ID Numbers: CP7001_5ACS
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
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Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases