Using Normal Volunteer Whole Blood or Plasma Samples to Establish the 99th Percentile Upper Reference Limit (URL) for the Meritas Troponin I Test

Trinity Biotech3 sites in 1 country769 target enrollmentMay 2015

ConditionsAcute Coronary Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Coronary Syndrome
Sponsor: Trinity Biotech
Enrollment: 769
Locations: 3
Primary Endpoint: 99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective multicenter sample collection and testing study.

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

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

July 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Trinity Biotech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Subjects with a history of heart failure and/or, having received treatment for heart failure.
•Subject with renal failure.
•Subjects with a history of unstable heart disease or angina complaints.
•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).
•Any known acute infection in the last 30 days.
•Marathon runners or extreme athletes.
•Pregnant (self-reported).