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Completed

NCT Number: NCT02638311

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

Prospective multicenter sample collection and testing study.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Trinity Biotech

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 23, 2015
Registry last updated
Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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