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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638311
• Other study ID #: CP7001_6URL
• Status: Completed
• Phase: N/A
• First received: December 14, 2015
• Last updated: December 17, 2015
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Trinity Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Prospective multicenter sample collection and testing study.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 769
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Locations

Country	Name	City	State
United States	Medical Research South	Charleston	South Carolina
United States	Tanner Clinic	Layton	Utah
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Trinity Biotech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population		1 day	No