Acute Coronary SyndromeNCT02638311
99th Percentile Upper Reference Limit (URL) for the Meritas Troponin I Test
An observational study of Acute Coronary Syndrome, run by Trinity Biotech at 3 sites in United States.
Trial summary
Prospective multicenter sample collection and testing study. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 769 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2015to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and females >21 years of age from diverse geographical locations and ethnicity-dispersed populations with an equal gender distribution
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical Research South
Charleston, South Carolina, 29407
Tanner Clinic
Layton, Utah, 84041
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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
Prospective multicenter sample collection and testing study.
Read the 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
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 769 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Rock, Study director, Trinity Biotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638311
- Sponsor's protocol ID
- CP7001_6URL
- Status last verified
- Dec 2015
- First submitted
- 14 Dec 2015
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02638311
- Acronym / sponsor ID
- CP7001_6URL
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 769 participants (actual)
- Lead sponsor
- Trinity BiotechIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective multicenter sample collection and testing study.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females >21 years of age from diverse geographical locations and ethnicity-dispersed populations with an equal gender distribution
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Rock study director
Trinity Biotech
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Trinity Biotech at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.