Myocardial InfarctionNCT02624024
Clinical Performance Evaluation of AQT90 FLEX TnI and TnT
An observational study of Myocardial Infarction, run by Radiometer Medical ApS at 8 sites in United States.
Trial summary
The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and laboratory settings. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 1,743 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2016to Jun 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects 21 years of age or older presenting to the emergency department (ED) with acute chest pain or equivalent ischemic symptoms suggestive of acute coronary syndromes (ACS) or acute myocardial infarction (MI).
Who may be able to join
- Subject is 21 years of age or older.
- Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study.
- Subject is presenting to the ED with acute chest pain or equivalent ischemic symptoms suggestive of ACS or MI (e.g., acute chest pain/pressure, shortness of breath, discomfort in upper extremity, jaw or epigastrium, diaphoresis, nausea, vomiting, lightheadedness, dizziness, weakness, and/or syncope).
Who cannot join
- Subject is pregnant or may be pregnant.
- Subject has an invalid written informed consent or has withdrawn consent.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Cincinnati Department of Emergency Medicine
Cincinnati, Ohio, 45267
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, 47303
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Honor Health Scottsdale Osborn Medical Center
Scottsdale, Arizona, 85251
Honor Health Scottsdale Shea Medical Center
Scottsdale, Arizona, 85258
Catholic Health Initiatives Institute for Research and Innovation -CHI Franciscan Health
Tacoma, Washington, 98405
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: AQT90 FLEX TnI and TnT - Clinical Sensitivity and Specificity Study
The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX TnI and TnT assays for both whole blood and plasma in the intended use population.
- Conditions
- Myocardial Infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute chest pain or equivalent ischemic symptoms | acute chest pain or equivalent ischemic symptoms suggestive of acute coronary syndromes (ACS) or acute myocardial infarction (MI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of acute myocardial infarction (MI)
Diagnosis of acute myocardial infarction (MI) that a subject was experiencing at the time of the subject's presentation to the ED, as determined by independent adjudication panel and based on the Third Universal Definition of Myocardial Infarction.
Measured: during the first 24 hours after presentation to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,743 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiometer Medical ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624024
- Sponsor's protocol ID
- DC-059975
- Status last verified
- Jun 2017
- First submitted
- 4 Dec 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AQT90 FLEX TnI and TnT - Clinical Sensitivity and Specificity Study
- ClinicalTrials.gov ID
- NCT02624024
- Acronym / sponsor ID
- DC-059975
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,743 participants (actual)
- Lead sponsor
- Radiometer Medical ApSIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 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.
The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX TnI and TnT assays for both whole blood and plasma in the intended use population.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute chest pain or equivalent ischemic symptoms | – | –acute chest pain or equivalent ischemic symptoms suggestive of acute coronary syndromes (ACS) or acute myocardial infarction (MI) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 21 years of age or older presenting to the emergency department (ED) with acute chest pain or equivalent ischemic symptoms suggestive of acute coronary syndromes (ACS) or acute myocardial infarction (MI).
Key inclusion criteria (3 listed)
- Subject is 21 years of age or older.
- Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study.
- Subject is presenting to the ED with acute chest pain or equivalent ischemic symptoms suggestive of ACS or MI (e.g., acute chest pain/pressure, shortness of breath, discomfort in upper extremity, jaw or epigastrium, diaphoresis, nausea, vomiting, lightheadedness, dizziness, weakness, and/or syncope).
Key exclusion criteria (2 listed)
- Subject is pregnant or may be pregnant.
- Subject has an invalid written informed consent or has withdrawn consent.
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
Diagnosis of acute myocardial infarction (MI)
Time frame: during the first 24 hours after presentation to the emergency department
Diagnosis of acute myocardial infarction (MI) that a subject was experiencing at the time of the subject's presentation to the ED, as determined by independent adjudication panel and based on the Third Universal Definition of Myocardial Infarction.
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 2 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Radiometer Medical ApS at 8 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 3 inclusion and 2 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Diagnosis of acute myocardial infarction (MI) (time frame: during the first 24 hours after presentation to the emergency department). 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 2 Jul 2017.