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
1 other identifier
observational
769
1 country
3
Brief Summary
Prospective multicenter sample collection and testing study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 14, 2015
CompletedFirst Posted
Study publicly available on registry
December 23, 2015
CompletedDecember 23, 2015
December 1, 2015
2 months
December 14, 2015
December 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population
1 day
Eligibility Criteria
Males and females \>21 years of age from diverse geographical locations and ethnicity-dispersed populations with an equal gender distribution
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trinity Biotechlead
Study Sites (3)
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Medical Research South
Charleston, South Carolina, 29407, United States
Tanner Clinic
Layton, Utah, 84041, United States
Biospecimen
EDTA plasma samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jim Rock
Trinity Biotech
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2015
First Posted
December 23, 2015
Study Start
May 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
December 23, 2015
Record last verified: 2015-12
Data Sharing
- IPD Sharing
- Will not share