VITROS Immunodiagnostic Products hs Troponin I
1 other identifier
observational
1,630
1 country
24
Brief 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 coronary syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2018
CompletedStudy Start
First participant enrolled
June 7, 2018
CompletedFirst Posted
Study publicly available on registry
July 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedSeptember 16, 2020
September 1, 2020
2 years
April 19, 2018
September 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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).
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).
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).
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).
VITROS hs Troponin I value at > 6 hours and up to 9 hours
Secondary Outcomes (2)
Risk stratification of subjects
Up to 12 months after last enrollment
Rule in and rule out myocardial infarction (MI)
VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours)
Eligibility Criteria
Individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS).
You may qualify if:
- 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.
You may not qualify if:
- Subject is unable to comply with the study requirements.
- Any samples which were not obtained under IRB approved protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Drug Research and Analysis Corp
Montgomery, Alabama, 36106, United States
Chandler Regional Medical Center
Chandler, Arizona, 85224, United States
Yale New Haven Hospital
New Haven, Connecticut, 06519, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Mass General Hospital
Boston, Massachusetts, 02114, United States
Wayne State University/Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Beaumont
Royal Oak, Michigan, 48073, United States
Hennepin County Medical Center/Minneapolis Medical Research Foundation
Minneapolis, Minnesota, 55404, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Oregon Health Science University Hospital
Portland, Oregon, 97239, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905, United States
Ben Taub General Hospital / Baylor College of Medicine/Harris Health System
Houston, Texas, 77030, United States
INOVA Alexandria Hospital
Alexandria, Virginia, 22304, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 29298, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
Medical College of Wisconsin and Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Biospecimen
Prospective collection of serial blood samples with serum and lithium heparin plasma.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fred Apple, PhD
Hennepin Healthcare Research Institute
- PRINCIPAL INVESTIGATOR
Richard Nowak, MD
Henry Ford Health System
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2018
First Posted
July 10, 2018
Study Start
June 7, 2018
Primary Completion
May 30, 2020
Study Completion
June 1, 2021
Last Updated
September 16, 2020
Record last verified: 2020-09