Study to determine the 99th percentile upper reference limit (URL) for the Minicare Cardiac Troponin (cTn-l) testing device in male and female adults

Study to determine the 99th percentile upper reference limit (URL) for the Minicare Cardiac Troponin (cTn-l) testing device in male and female adults - Minicare cTn-I system study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42657

Enrollment

850

Registered

2015-04-02

Start date

2015-09-14

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

myocardial infarction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male and female subjects *18 years old

Exclusion criteria

Exclusion criteria: 1. Personal history of AMI or other cardiac diseases (MI, angina, stroke, atrial fibrillation, peripheral vascular disease (PVD), deep vein thrombosis (DVT), pulmonary embolism (PE), cardiac valve disease, heart failure), chronic obstructive pulmonary disease (COPD), immunological disease (eg. systemic lupus erythematosis [SLE] and reumatoid arthritis), diabetes mellitus, hypertension (except for subjects *70 years on stable medication for hypertension and normal/stabilized blood pressure) or drug-of-abuse (based on questionnaire) 2. History of cancer in last 5 years (evaluation through questionnaire).

Design outcomes

Primary

Measure	Time frame
To determine the 99th percentile URL of the Minicare cardiac troponin-I (cTn-I) system in healthy male and female adults according to clinical laboratory standards institute (CLSI) C28 A3 recommendations.	—

Countries

Netherlands

Outcome results