Acute Coronary Syndrome (ACS)NCT03581578
VITROS Immunodiagnostic Products hs Troponin I
An observational study of Acute Coronary Syndrome (ACS) and Myocardial Infarction, run by Ortho-Clinical Diagnostics, Inc. at 24 sites in United States.
Trial summary
The purpose of this clinical study is to collect data to substantiate the use of the VITROS hs Troponin I test as an aid in the diagnosis of myocardial infarction (MI). The test is further indicated for risk stratification of mortality, myocardial infarction or coronary revascularization in patients with acute… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Acute Coronary Syndrome (ACS), Myocardial Infarction
- How many people
- 1,630 participants
- Where
- 24 sitesUnited States
- Study dates
- 7 Jun 2018to Jun 2021
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS).
Who may be able to join
- Subject must be ≥22 years of age at the time of consent.
- Subject presenting with symptoms suggestive of acute coronary syndrome including chest pain, or chest pain equivalent.
- Must have an Electrocardiogram (ECG) ordered as part of the subject's standard of care.
- Subject willing and able to provide informed consent.
Who cannot join
- Subject is unable to comply with the study requirements.
- Any samples which were not obtained under IRB approved protocol.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
INOVA Alexandria Hospital
Alexandria, Virginia, 22304
University of Maryland
Baltimore, Maryland, 21201
Mass General Hospital
Boston, Massachusetts, 02114
Cooper University Hospital
Camden, New Jersey, 08103
Chandler Regional Medical Center
Chandler, Arizona, 85224
Medical University of South Carolina
Charleston, South Carolina, 29425
Charleston Area Medical Center
Charleston, West Virginia, 25304
University of Cincinnati
Cincinnati, Ohio, 45267
UT Southwestern Medical Center
Dallas, Texas, 75390
Wayne State University/Detroit Receiving Hospital
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905
Ben Taub General Hospital / Baylor College of Medicine/Harris Health System
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
Medical College of Wisconsin and Froedtert Hospital
Milwaukee, Wisconsin, 53226
Hennepin County Medical Center/Minneapolis Medical Research Foundation
Minneapolis, Minnesota, 55404
Drug Research and Analysis Corp
Montgomery, Alabama, 36106
Yale New Haven Hospital
New Haven, Connecticut, 06519
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Oregon Health Science University Hospital
Portland, Oregon, 97239
Virginia Commonwealth University Medical Center
Richmond, Virginia, 29298
Beaumont
Royal Oak, Michigan, 48073
Stony Brook University Hospital
Stony Brook, New York, 11794
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The purpose of this clinical study is to collect data to substantiate the use of the VITROS hs Troponin I test as an aid in the diagnosis of myocardial infarction (MI). The test is further indicated for risk stratification of mortality, myocardial infarction or coronary revascularization in patients with acute coronary syndrome.
Read the detailed description
A prospective clinical sample collection and cardiac troponin I testing will be conducted in individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS) at geographically dispersed sites in the US. Individuals who meet the inclusion/exclusion criteria, including having signed an informed consent form will be included in the study.
Clinical and laboratory data will be collected to demonstrate product performance compared to an adjudicated clinical diagnosis.
Sample collection and testing of clinical samples with the VITROS hs Troponin I test will be performed under two separate protocols.
- Keywords
- Troponin
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the VITROS hs Troponin I test
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
Measured: VITROS hs Troponin I value at baseline
Sensitivity and specificity of the VITROS hs Troponin I test
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
Measured: VITROS hs Troponin I value > 1 hour and up to 3 hours
Sensitivity and specificity of the VITROS hs Troponin I test
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
Measured: VITROS hs Troponin I value at > 3 hours and up to 6 hours
Sensitivity and specificity of the VITROS hs Troponin I test
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
Measured: VITROS hs Troponin I value at > 6 hours and up to 9 hours
Secondary outcomes (2)
Risk stratification of subjects
Assess the use of cardiac Troponin I measurement in the risk stratification of subjects.
Measured: Up to 12 months after last enrollment
Rule in and rule out myocardial infarction (MI)
Evaluate the VITROS hs Troponin I test to rule in and rule out MI.
Measured: VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start7 Jun 2018
- Primary completion30 May 2020
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome (ACS)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ortho-Clinical Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Apple, PhD, Principal investigator, Hennepin Healthcare Research InstituteRichard Nowak, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581578
- Sponsor's protocol ID
- 16-002
- Status last verified
- Sep 2020
- First submitted
- 19 Apr 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITROS Immunodiagnostic Products hs Troponin I
- ClinicalTrials.gov ID
- NCT03581578
- Acronym / sponsor ID
- 16-002
- Keywords
- Troponin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,630 participants (estimated)
- Lead sponsor
- Ortho-Clinical Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- Jun 2021 (estimated)
- First posted
- 10 Jul 2018 (actual)
- 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 purpose of this clinical study is to collect data to substantiate the use of the VITROS hs Troponin I test as an aid in the diagnosis of myocardial infarction (MI). The test is further indicated for risk stratification of mortality, myocardial infarction or coronary revascularization in patients with acute coronary syndrome.
Detailed description
A prospective clinical sample collection and cardiac troponin I testing will be conducted in individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS) at geographically dispersed sites in the US. Individuals who meet the inclusion/exclusion criteria, including having signed an informed consent form will be included in the study.
Clinical and laboratory data will be collected to demonstrate product performance compared to an adjudicated clinical diagnosis.
Sample collection and testing of clinical samples with the VITROS hs Troponin I test will be performed under two separate protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS).
Key inclusion criteria (4 listed)
- Subject must be ≥22 years of age at the time of consent.
- Subject presenting with symptoms suggestive of acute coronary syndrome including chest pain, or chest pain equivalent.
- Must have an Electrocardiogram (ECG) ordered as part of the subject's standard of care.
- Subject willing and able to provide informed consent.
Key exclusion criteria (2 listed)
- Subject is unable to comply with the study requirements.
- Any samples which were not obtained under IRB approved protocol.
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
Sensitivity and specificity of the VITROS hs Troponin I test
Time frame: VITROS hs Troponin I value at baseline
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
Sensitivity and specificity of the VITROS hs Troponin I test
Time frame: VITROS hs Troponin I value > 1 hour and up to 3 hours
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
Sensitivity and specificity of the VITROS hs Troponin I test
Time frame: VITROS hs Troponin I value at > 3 hours and up to 6 hours
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
Sensitivity and specificity of the VITROS hs Troponin I test
Time frame: VITROS hs Troponin I value at > 6 hours and up to 9 hours
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
2 secondary outcomes
Risk stratification of subjects
Time frame: Up to 12 months after last enrollment
Rule in and rule out myocardial infarction (MI)
Time frame: VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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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.
Fred Apple, PhD principal investigator
Hennepin Healthcare Research Institute
Richard Nowak, MD principal investigator
Henry Ford Health System
24 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 (ACS) and Myocardial Infarction, run by Ortho-Clinical Diagnostics, Inc. at 24 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 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: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
Results are not available in the source record.
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?
Sensitivity and specificity of the VITROS hs Troponin I test (time frame: VITROS hs Troponin I value at baseline). The study lists 4 primary outcomes in all. 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 16 Sep 2020.