MedDataX Logo

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

NCT ID: NCT02638311

Last Updated: 2015-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

769 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective multicenter sample collection and testing study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Coronary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Trinity Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jim Rock

Role: STUDY_DIRECTOR

Trinity Biotech

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Medical Research South

Charleston, South Carolina, United States

Site Status

Tanner Clinic

Layton, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CP7001_6URL

Identifier Type: -

Identifier Source: org_study_id