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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02638311

Enrollment

769

Registered

2015-12-23

Start date

2015-05-31

Completion date

2015-07-31

Last updated

2015-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

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

Countries

United States

Outcome results