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

Prospective multicenter sample collection and testing study.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome

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

• Study Type: Observational
• Enrollment (Actual): 769

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Medical Research South
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Males and females >21 years of age from diverse geographical locations and ethnicity-dispersed populations with an equal gender distribution

Description

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).

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Trinity Biotech
• Investigators: Study Director: Jim Rock, Trinity Biotech

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 23, 2015

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: CP7001_6URL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No