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

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT02638311
• Lead Sponsor: Trinity Biotech

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

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-12
• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2015-12-17
• Last Update Submitted: 2015-12-17
• Study First Posted: 2015-12-23
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 769

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population	1 day

Trial Locations

Locations (3)

Tanner Clinic; 🇺🇸 Layton, Utah, United States

Medical Research South; 🇺🇸 Charleston, South Carolina, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States