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99th Percentile Upper Reference Limit (URL) for the Meritas Troponin I Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638311
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Trinity Biotech

Brief Summary:
Prospective multicenter sample collection and testing study.

Condition or disease
Acute Coronary Syndrome

Detailed Description:
Prospective multicenter sample collection and testing study. Approximately 750 apparently healthy subjects, including healthy subjects with stable co-morbidities, age, gender and ethnicity dispersed will be eligible for enrollment

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Study Type : Observational
Actual Enrollment : 769 participants
Time Perspective: Prospective
Official Title: Using Normal Volunteer Whole Blood or Plasma Samples to Establish the 99th Percentile Upper Reference Limit (URL) for the Meritas Troponin I Test
Study Start Date : May 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015



Primary Outcome Measures :
  1. 99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population [ Time Frame: 1 day ]

Biospecimen Retention:   Samples With DNA
EDTA plasma samples


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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Males and females >21 years of age from diverse geographical locations and ethnicity-dispersed populations with an equal gender distribution
Criteria

Inclusion Criteria:

  1. Male or female at least 21 years of age at the time of enrollment in the study.
  2. Subjects with no medications or no changes in their medications in the last 3 months.
  3. Subjects with and without chronic stable morbidities (i.e., renal insufficiency, hypertension, diabetes, hypercholesterolemia, pulmonary disorders, coronary disease, musculoskeletal disorders, etc.).
  4. Subjects able to understand and sign the informed consent and the patient questionnaire.

Exclusion Criteria:

  1. Subjects with a history of heart failure and/or, having received treatment for heart failure.
  2. Subject with renal failure.
  3. Subjects with a history of unstable heart disease or angina complaints.
  4. Subjects with any change in their medication in the last 3 months (diabetics may have small variations in glucose medications but may not have unstable disease, or have suffered a diabetic crisis in the last 6 months).
  5. Any known acute infection in the last 30 days.
  6. Marathon runners or extreme athletes.
  7. Pregnant (self-reported).

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): NCT02638311


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical Research South
Charleston, South Carolina, United States, 29407
United States, Utah
Tanner Clinic
Layton, Utah, United States, 84041
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: NCT02638311    
Other Study ID Numbers: CP7001_6URL
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases