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

Trinity Biotech

Status: Completed

Conditions: Acute Coronary Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT02638311

CP7001_6URL

Details and patient eligibility

About

Prospective multicenter sample collection and testing study.

Full 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

Enrollment: 769 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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).