Myocardial Infarction Clinical Trial
Official title:
VITROS Immunodiagnostic Products hs Troponin I
NCT number | NCT03581578 |
Other study ID # | 16-002 |
Secondary ID | |
Status | Active, not recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 7, 2018 |
Est. completion date | June 2021 |
Verified date | September 2020 |
Source | Ortho-Clinical Diagnostics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 1630 |
Est. completion date | June 2021 |
Est. primary completion date | May 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility |
Inclusion Criteria: 1. Subject must be =22 years of age at the time of consent. 2. Subject presenting with symptoms suggestive of acute coronary syndrome including chest pain, or chest pain equivalent. 3. Must have an Electrocardiogram (ECG) ordered as part of the subject's standard of care. 4. Subject willing and able to provide informed consent. Exclusion Criteria: 1. Subject is unable to comply with the study requirements. 2. Any samples which were not obtained under IRB approved protocol. |
Country | Name | City | State |
---|---|---|---|
United States | INOVA Alexandria Hospital | Alexandria | Virginia |
United States | University of Maryland | Baltimore | Maryland |
United States | Mass General Hospital | Boston | Massachusetts |
United States | Cooper University Hospital | Camden | New Jersey |
United States | Chandler Regional Medical Center | Chandler | Arizona |
United States | Charleston Area Medical Center | Charleston | West Virginia |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Wayne State University/Detroit Receiving Hospital | Detroit | Michigan |
United States | Texas Tech University Health Sciences Center El Paso | El Paso | Texas |
United States | Ben Taub General Hospital / Baylor College of Medicine/Harris Health System | Houston | Texas |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Medical College of Wisconsin and Froedtert Hospital | Milwaukee | Wisconsin |
United States | Hennepin County Medical Center/Minneapolis Medical Research Foundation | Minneapolis | Minnesota |
United States | Drug Research and Analysis Corp | Montgomery | Alabama |
United States | Yale New Haven Hospital | New Haven | Connecticut |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | Oregon Health Science University Hospital | Portland | Oregon |
United States | Virginia Commonwealth University Medical Center | Richmond | Virginia |
United States | Beaumont | Royal Oak | Michigan |
United States | Stony Brook University Hospital | Stony Brook | New York |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Ortho-Clinical Diagnostics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Risk stratification of subjects | Assess the use of cardiac Troponin I measurement in the risk stratification of subjects. | Up to 12 months after last enrollment | |
Secondary | Rule in and rule out myocardial infarction (MI) | Evaluate the VITROS hs Troponin I test to rule in and rule out MI. | VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours) |
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